#209128 TOA FDA Deskbook P2 1.

Table of Authorities

(References are to pages.)

CASES

AAbel v. United States ................................................................. 22-11Admin. Compl., CTP v. C&C Supermarket, LLC ..................... 14-25Admin., Subpoena Doe v. United States, In re .......................... 22-11Advance Pharm., Inc. v. United States ...................................... 17-27Akzo Nobel Chems. Ltd. v. European Comm’n ........................ 20-39Amarin Pharma, Inc. v. FDA ............................. 18-21, 18-22, 22-32Amarin Pharma, Inc. v. Food and Drug Admin. ....................... 19-57Am. Snuff Co. v. United States ................................................. 14-18Anheuser-Busch, Inc., In re ......................................................... 4-29Avocent Redmond Corp. v. Rose Elecs., Inc. ............................. 22-23

BBackus v. Nestlé USA, Inc. .......................................................... 4-34Bank of Am., N.A. v. Terra Nova Ins. Co. ................................ 20-33Basic Research, LLC v. FTC ...................................................4-7, 4-8Bieter Co., In re ......................................................................... 22-19Braswell v. United States ........................................................... 22-14Burwell v. Hobby Lobby Stores, Inc. .......................................... 22-14Butterworth v. Smith ................................................................. 22-17

CCardwell v. Bechtol ...................................................................... 8-41Carter v. Cornell Univ. .............................................................. 20-18Ctr. for Food Safety v. Price ....................................................... 13-23

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Ctr. for Sci. in the Pub. Interest v. Price .................................... 13-31Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n .......... 22-31Christopher v. SmithKline Beecham Corp. ............................... 22-33Cigar Ass’n of Am. v. FDA ........................................................ 14-27Commonwealth Brands, Inc. v. FDA ........................................ 14-18Cmty. Nutrition Inst. v. Young ...................................................... 2-7Continental Oil Co. v. United States ........................................ 20-17Compl., Mager v. Quality Egg, LLC. ......................................... 13-42Cutler v. Hayes .............................................................................. 2-7Cyclops Vapor 2 v. FDA ............................................................. 14-27

DDe Keczer v. Tetley USA Inc. ..................................................... 16-14Discount Tobacco City & Lottery v. United States ................... 14-18Diversified Indus. v. Meredith ................................................... 20-33Doe v. United States .................................................................. 22-12Douglas Oil Co. v. Petrol Stops Nw. ......................................... 22-17

EEbner v. Fresh, Inc. ...................................................................... 4-31E.K. Ekcessories Inc., In re .......................................................... 4-10Elizabeth Luddy, et al. ............................................................... 15-29Ewing v. Mytinger & Casselberry, Inc. ........................................ 2-10

FFaircloth v. FDA ........................................................................ 14-27Farm Raised Salmon Cases, In re ............................................. 13-66FCC v. Fox Television Stations, Inc. .......................................... 22-33Firestone Tire & Rubber Co. v. FTC ............................................. 4-6Fisher v. United States ............................ 22-11, 22-15, 22-19, 22-21Florida v. Harden ....................................................................... 19-22Four Hundred and Forty-Three Cans of Frozen Egg Prod. v.

United States ........................................................................ 2-13Franks v. Delaware .................................................................... 22-24FTC v. 7 Day Mktg., Inc. ............................................................ 4-10FTC v. Chemence, Inc. ................................................................. 4-9FTC v. Colgate-Palmolive Co. ....................................................... 4-5FTC v. Iovate Health Scis. USA, Inc. ............................................ 4-4

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FTC v. POM Wonderful ............................................................ 16-20FTC v. Ruberoid Co. ...................................................................... 4-5FTC v. Skechers U.S.A. ............................................................. 16-20FTC v. TRW, Inc. ....................................................................... 20-18

GGilman v. Marsh ....................................................................... 20-15Grand Jury, In re ..................................... 20-17, 22-14, 22-16, 22-22Grand Jury Subpoena, In re ................................ 20-17, 22-16, 22-22

HHale v. Henkel ................................................................22-11, 22-14Hanlester Network v. Shalala ...................................................... 19-5Healthpoint, Ltd. v. Ethex Corp. ................................................... 2-7Heckler v. Chaney ......................................................................... 2-8Hickman v. Taylor ..........................................................20-18, 22-12HiFi DNA Tech, LLC v. Dep’t of Health & Human Servs. ........... 12-5

IIcaza v. FDA .............................................................................. 14-27Illinois v. Gates ......................................................................... 22-24In re Admin. Subpoena Doe v. United States ............................ 22-11In re Anheuser-Busch, Inc. .......................................................... 4-29In re Bieter Co. .......................................................................... 22-19In re E.K. Ekcessories Inc. ........................................................... 4-10In re Farm Raised Salmon Cases .............................................. 13-66In re Grand Jury ........................................ 20-17, 22-14, 22-26, 22-22In re Grand Jury Subpoena ................................. 20-17, 22-16, 22-22In re Kellogg Brown & Root, Inc. ...................................20-14, 20-18In re Leslie Fay Cos., Inc. Sec. Litig. ......................................... 20-33In re Nestlé HealthCare Nutrition, Inc. ........................................ 4-4In re Pharm. Indus. Average Wholesale Price Litig. ................. 19-22,

..................................................................................19-51, 19-53In re POM Wonderful and Roll Global LLC .................................. 4-6In re Qwest Commc’ns Int’l ..................................................... 20-33In re Royal Ahold ...........................................................20-32, 20-33In re Royal Ahold N.V. Sec. & ERISA Litig. ...................20-32, 20-33In re Schering Corp. ...........................................................4-4, 18-12



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In re Subpoena Duces Tecum v. Bailey ............... 22-11, 22-14, 22-15In re Swearingen Aviation Corp. ............................................... 22-17In re Thompson Medical Co. ........................................................ 4-4In re Vital Basics, Inc. ............................................................... 18-12Int’l Ctr. for Tech. Assessment v. Thompson ............................ 15-21Intex Recreation Corp. v. Team Worldwide Corp. ..................... 22-23Izquierdo v. Mondelez Int’l, Inc. .................................................. 4-31

JJones v. Rath Packing Co. ............................................................ 13-4Jones v. United States ................................................................ 22-24

KKeefe v. Bernard ......................................................................... 20-32Kellogg Brown & Root, Inc., In re ..................................20-14, 20-18Klaczak v. Consol. Med. Transp. ................................................. 19-9Koenig v. Boulder Brands, Inc. ................................................... 13-66Kordel v. United States ........................................... 1-10, 13-25, 18-5

LLeslie Fay Cos., Inc. Sec. Litig., In re ........................................ 20-33Lorillard, Inc. v. FDA ................................................................... 14-6Lost Art Liquids, LLC v. FDA .................................................... 14-27Loving v. United States .................................................................. 3-3

MMaryland v. Garrison ................................................................ 22-25Massachusetts v. Mylan Labs, Inc. ............................................ 19-53Masters Pharm., Inc. v. DEA ..................................................... 17-24Maxwell v. Unilever ................................................................... 16-14Med. Ctr. Pharmacy v. Mukasey ................................................... 7-4Medtronic, Inc. v. Lohr ............................................. 4-28, 4-33, 4-34Millet, Pit and Seed Co. v. United States .......................13-10, 13-11Monsanto Co. v. Kennedy ................................................13-20, 16-9Moore v. Publicis Groupe .......................................................... 20-23Murphy v. Waterfront Comm’n of N.Y. Harbor ........................ 22-14

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Mutual Pharm. Co. v. Bartlett ..................................................... 4-33M.W. Scott v. FDA ....................................................................... 16-9

NNatick Paperboard Corp. v. Weinberger ..................................... 13-20Neder v. United States ................................................................. 3-10Nestlé HealthCare Nutrition, Inc., In re ....................................... 4-4New Eng. Carpenters Health and Welfare Fund v.

AstraZeneca ........................................................................ 19-36Nicopure Labs, LLC v. FDA ....................................................... 14-27Nutrilab, Inc. v. Schweiker .......................................................... 13-4

PPearson v. Shalala ...................................................................... 13-28Pharm. Indus. Average Wholesale Price Litig., In re ................ 19-22,

..................................................................................19-51, 19-53Philip Morris USA Inc. v. FDA ........................................14-7, 14-10Planned Parenthood of Cent. Mo. v. Danforth ............................ 8-40PLIVA, Inc. v. Mensing ................................................................ 4-33POM Wonderful and Roll Global LLC, In re ..........................4-4, 4-6POM Wonderful, LLC v. FTC ....................................................... 4-6Premo Pharm. Labs., Inc. v. United States .................................... 5-4Prof ’ls and Patients for Customized Care v. Shalala ..................... 7-4Pub. Citizen v. Arthur Hull Hayes ............................................ 13-21Pub. Citizen v. Young .................................................................. 16-8

QQwest Commc’ns Int’l, In re .................................................... 20-33

RRichard M. Cooper et al. ............................................................. 4-29Riegel v. Medtronic, Inc. .............................................................. 4-34R.J. Reynolds Tobacco Co. v. FDA ............... 12-22, 14-7, 14-18, 14-19Royal Ahold, In re ..........................................................20-32, 20-33Royal Ahold N.V. Sec. & ERISA Litig., In re .................... 20-32, 20-33



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SSamet v. Proctor & Gamble Co. .................................................. 4-28Schering Corp., In re ..........................................................4-4, 18-12Sciortino v. Pepsico, Inc. .............................................................. 4-31SEC v. Texas Gulf Sulphur Co. .................................................. 20-36Sorrell v. IMS Health, Inc. ......................................................... 22-31Subpoena Duces Tecum v. Bailey, In re .............. 22-11, 22-14, 22-15Swearingen Aviation Corp., In re .............................................. 22-17

TThompson v. W. States Med. Ctr. ......................................7-4, 15-22Thompson Medical Co., In re ....................................................... 4-4TMJ Implants v. HHS ................................................................. 1-20Trentham v. Continental Mills, Inc. ............................................ 4-31

UUnited States v. 9/1 Kg. Containers, More or Less .................... 15-22United States v. 22 Rectangular or

Cylindrical Finished Devices ................................................ 2-19United States v. 25 Cases, More or Less, of an Article of

Device-Sensor Pad for Breast Examination ........................... 12-3United States v. 29 Cartons ...................................................... 13-19United States v. 39 Cases, More or Less,

Each Case Containing 72/100 ............................................ 13-41United States v. 101 Cases .......................................................... 2-11United States v. 216 Bottles, More or Less, Sudden Change

by Lanolin Plus Lab. Div. Hazel Bishop Inc. ........................ 2-13United States v. 1232 Cases Am. Beauty Brand Oysters ........... 13-11United States v. 1961 Labeled ..................................................... 2-11United States v. 1961 Labeled Cases and Ascend Labs., LLC ....... 2-21United States v. 2035, Inc. .......................................................... 2-21United States v. Abbott Labs. ...........................................2-22, 19-41United States v. ACRI Wholesale Grocery Co. .............................. 3-6United States v. Akhtar ............................................................. 17-14United States v. Alpha Therapeutic Corp. ................................... 2-22United States v. Anderson Seafoods, Inc. .........................13-9, 13-10United States v. Ariz. Canning Co. ............................................. 2-13United States v. Arlen ................................................................. 3-10United States v. Article of a Drug ............................................... 12-3United States v. Article of a Drug—OVA II ................................. 12-3

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United States v. Articles of Drug ................................................. 2-15United States v. Atrium Med. Corp. ........................................... 2-21United States v. Barr Labs., Inc. .................................................. 2-15United States v. Bayer Corp. ......................................................... 4-8United States v. Biomet Orthopedics, Inc. ................................ 19-41United States v. Borrasi ....................................................19-5, 19-15United States v. Bradshaw ........................................................... 3-10United States v. Carlson ................................................................ 3-4United States v. Caronia ................................... 18-21, 18-22, 18-23,

........................................................... 19-56, 19-57, 22-31, 22-32United States v. Celgene Corp. .........................................19-5, 19-42United States v. City and County of San Francisco ...................... 2-15United States v. Cole ................................................................... 2-21United States v. Collier ............................................................... 17-7United States v. ConAgra Grocery Prods., Co. .......................... 13-44United States v. Crown Rubber Sundries Co. ............................ 13-45United States v. Davis ............................................................... 20-18United States v. DeCoster ......................................................... 13-43United States v. Depuy Orthopaedics, Inc. ................................ 19-41United States v. Diapulse Corp. of Am. ...................................... 2-15United States v. Dotterweich ........................................ 3-4, 3-5, 22-5United States v. Endotec, Inc. ..................................................... 2-15United States v. FedEx Corp. ..........................................17-29, 17-30United States v. Franck’s Lab, Inc. ..................... 15-22, 15-23, 15-35United States v. Gaudin .............................................................. 3-10United States v. Gel Spice Co. ...............................................3-7, 3-8United States v. Gen. Nutrition, Inc. ........................................ 13-42United States v. Genzyme ........................................................... 2-23United States v. Grab Bag Distrib. ............................................ 17-15United States v. Greber ............................................................... 19-5United States v. Green Drugs .................................................... 17-14United States v. Grimaud .............................................................. 3-3United States v. Haga .................................................................... 3-9United States v. Hammer Corp. ................................................ 17-28United States v. Heim ............................................................... 17-18United States v. Hiland ................................................................. 3-9United States v. Hill .................................................................... 2-21United States v. Jason Pharm., Inc. ............................................... 4-4United States v. Jensen .............................................................. 13-44United States v. Kats ................................................................... 19-5United States v. Kensington Hosp. ............................................ 19-20United States v. Kos Pharm. ...................................................... 19-44United States v. Laclede, Inc. ...................................................... 2-21United States v. Lane Labs-USA, Inc. .................................2-15, 2-23



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United States v. Lecroy .............................................................. 20-17United States v. Lexington Mill & Elevator Co. ............... 13-10, 13-19United States v. Little .....................................................17-14, 17-15United States v. Luis ......................................................19-15, 19-26United States v. Matrix Biokinetics, Inc. ..................................... 2-20United States v. Mayfield .......................................................... 13-45United States v. Medina ............................................................ 19-29United States v. Mitcheltree .................................................3-9, 3-10United States v. Moore ................................................................ 17-7United States v. Morgan .............................................................. 22-5United States v. Morton Salt Co. .............................................. 22-10United States v. New Eng. Grocers Supply Co. ......................3-7, 3-8United States v. N.Y. Fish, Inc. ................................................... 2-16United States v. O.F. Bayer & Co. ............................................... 13-4United States v. Organic Pastures Dairy Co. ............................... 2-19United States v. Palazzo ................................................................. 3-3United States v. Parfait Powder Puff Co. ................................... 13-45United States v. Park .........................1-10, 3-5, 3-7, 6-3, 13-42, 13-43United States v. Parke-Davis ............................................3-17, 19-56United States v. Parnell ............................................................. 13-44United States v. Pfizer, Inc. ....................................................... 19-41United States v. Poulin .............................................................. 17-15United States v. Pro-Ag, Inc. ....................................................... 2-14United States v. R. Enters., Inc. ................................................ 22-10United States v. Rhody Dairy, LLC ........................................... 15-35United States v. Ross ................................................................. 22-25United States v. Ruehle ............................................................. 22-21United States v. Rx Depot, Inc. ................................................... 2-23United States v. Sawyer ............................................................. 22-23United States v. SB Pharmco Puerto Rico, Inc. ......................... 19-58United States v. Scenic View Dairy, LLC ................................... 15-35United States v. Schering-Plough Corp. ....................................... 2-23United States v. Sells Eng’g, Inc. ............................................... 22-17United States v. Serono Labs. Inc. ............................................. 19-43United States v. Shaw .................................................................. 19-8United States v. Smith .................................................................. 3-3United States v. Smith & Nephew, Inc. .................................... 19-41United States v. SmithKline Beecham Corp. ............................. 19-58United States v. Specialty Compounding LLC ............................ 2-21United States v. Starr .................................................................... 3-8United States v. Stein .....................................................20-16, 22-13United States v. Stepney ............................................................ 20-17United States v. Stidham ........................................................... 17-14United States v. Sunland, Inc. ................................................... 13-39

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United States v. Takeda Pharm. Co. .......................................... 19-57United States v. Terumo Cardiovascular Sys. .............................. 2-23United States v. Two Plastic Drums .......................................... 13-19United States v. Undetermined No. of

Unlabeled Cases—Clinical Reference Laboratory ........ 12-4, 12-30United States v. Undetermined Quantities of

Elderberry Juice ................................................................... 13-41United States v. Undetermined Quantities of

Elderberry Juice Concentrate ................................................ 2-11United States v. United Shoe Mach. Corp. ............................... 20-14United States v. Utah Med. Prods., Inc. ...................................... 2-20United States v. Vascular Sols., Inc. ..............................18-23, 19-57,

............................................................................ 20-9, 2-32, 2-33United States v. Warning ........................................................... 19-20United States v. Watkins ............................................................... 3-9United States v. Weissman ........................................................ 20-17United States v. Wiesenfeld Warehouse Co. .................................. 3-7United States v. Wilkerson ........................................................ 13-44United States v. X-Otag Plus Tablets ........................................... 2-14United States v. Y. Hata & Co. ..............................................3-6, 3-8United States v. Zimmer, Inc. ................................................... 19-41United States v. Parfait Powder Puff Co. ................................... 13-45United States ex rel. Banigan v. Organon USA, Inc. ........ 19-12, 19-49United States ex rel. Denk v. PharMerica Corp. ....................... 17-19United States ex rel. Herman v. Coloplast Corp., .................... 19-12,

..................................................................................19-13, 19-49United States ex rel. Jamison v. McKesson Corp. ....................... 19-9United States ex rel. Nowak v. Medtronic, Inc. .............19-51, 19-56United States ex rel. Polansky v. Pfizer ..................................... 19-57United States ex rel. Rostholder v. Omnicare, Inc. ................... 19-58United States ex rel. Walsh v. Eastman Kodak Co. ................... 19-12Upjohn Co. v. United States ............................. 20-17, 20-18, 20-22,

................................................... 20-28, 20-29, App. 20B-1, 22-2,

................................................22-12, 22-19, 22-20, 22-21, 22-22

VVictor v. R.C. Bigelow, Inc. ........................................................ 16-14Vital Basics, Inc., In re .............................................................. 18-12



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WWedgewood Vill. Pharm., Inc. v. United States ......................... 21-11Weinberger v. Bentex Pharm., Inc. ................................................. 5-4W. States Med. Ctr. v. Shalala ....................................................... 7-4Wilson v. Frito-Lay N. Am., Inc. ............................................... 16-14WLF v. Friedman ............................................................18-21, 22-31WLF v. Henney ...............................................................18-21, 22-31Wyeth v. Levine ........................................................................... 4-33

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STATUTES

Statutes by Name21st Century Cures Act ......................................................8-4, 18-11Affordable Care Act (ACA) ..................................... 4-18, 13-30, 19-5

§ 3301 ............................................................................... 19-7§ 6002 ............................................................................. 19-22§ 6004 ............................................................................. 19-23§ 6402(f)(1) .............................................................19-6, 19-51§ 6402(f)(2) ........................................................................ 19-5

Administrative Procedure Act (APA) .................. 5-6, 7-4, 14-6, 14-10Alcohol, Drug Abuse and

Mental Health Administration Reorganization Act ............ 14-20Alcoholic Beverage Labeling Act (ABLA) .................................... 13-61Animal Medicinal Drug Use Clarification Act of

1994 (AMDUCA) ............................................................... 15-30Animal Welfare Act ............................................................4-14, 4-15Anti-Kickback Act of 1986 ........................................................ 19-20California False Claims Act ....................................................... 19-39California’s Protection of Human Subjects in

Medical Experimentation Act ................................................. 8-5California’s Safe Drinking Water and

Toxic Enforcement Act of 1986 ............................................ 4-31Chemical Diversion and Trafficking Act of 1988 ........................ 4-11Civil Asset Forfeiture Reform Act of 2000 ................................ 17-16Clinical Laboratory Improvement Act (CLIA) ........................... 12-11Combat Methamphetamine Epidemic Act of

2005 (CMEA) ......................................... 4-11, 17-2, 17-7, 17-28Compounding Quality Act .................7-7, 7-8, 7-12, 7-13, 7-19, 7-20,

..................................... 7-21, 7-23, 7-25, 7-26, 7-27, 15-23, 15-24§ 102 ................................................................................. 7-18§ 103 ................................................................................. 7-20

Comprehensive Drug Abuse Prevention andControl Act of 1970 ....................................................4-11, 17-2

Comprehensive Smokeless Tobacco Health andEducation Act (CSTHEA) ................................................... 14-15

Consolidated Appropriations Act .....................................4-24, 13-30Consumers Legal Remedies Act .................................................. 4-28Controlled Substances Act (CSA) .......................... 4-11, 4-12, 17-10,

...................................................................... 17-19, 17-26, 17-28Deficit Reduction Act of 2005 (DRA) .......................................... 4-29Diagnostic Accuracy and Innovation Act .................................. 12-20



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Dietary Supplement and NonprescriptionDrug Consumer Protection Act ............................................ 21-7

Dietary Supplement Health and Education Act of1994 (DSHEA) ...........................................................13-4, 15-15

Drug Amendments Act of 1962 .................................................... 5-4§ 101 ................................................................................... 6-3

Drug Price Competition and Patent TermRestoration Act of 1984 ...................................................1-4, 1-7

Drug Quality and Security Act of 2013 (DQSA) ......... 7-7, 7-8, 7-26,..................................................7-27, 15-23, 15-24, 15-25, 15-26

Egg Product Inspection Act (EPIA) ............... 13-3, 13-5, 13-24, 13-48,..................................................13-49, 13-51, 13-53, 13-54, 13-66

Ensuring Patient Access and EffectiveDrug Enforcement Act of 2016 ...............................17-12, 17-13

Fair Packaging and Labeling Act (FPLA) .............. 13-3, 13-24, 13-54,............................................................. 16-2, 16-14, 16-15, 16-16

False Claims Act ........................ 3-16, 4-19, 4-22, 4-29, 4-30, 17-19,....................................... 19-4, 19-6, 19-10, 19-31, 19-33, 19-39,........................ 19-41, 19-48, 19-49, 19-50, 19-51, 19-52, 19-53,........................... 19-54, 19-55, 19-56, 19-57, 19-58, 19-59, 22-8

Family Smoking Prevention and TobaccoControl Act ........1-4, 14-2, 14-3, 14-4, 14-5, 14-7, 14-10, 14-15,................14-16, 14-18, 14-20, 14-21, 14-22, 14-23, 14-24, 14-25

FDA Modernization Act (FDAMA) ............................... 1-4, 7-3, 7-4,................................................................. 7-22, 7-25, 8-59, 13-28

§ 113 ........................................................................8-47, 8-48§ 114 ............................................................................... 18-11§ 130(a) ............................................................................. 8-59§ 503A ................................................................................. 7-4§ 519 ................................................................................. 11-3

FDC Act of 1906 ....................................................................1-4, 6-3FDC Act of 1962 ........................................................................... 5-2Federal Advisory Committee Act ................................................. 14-6Federal Alcohol Administration Act ................... 13-24, 13-61, 13-62Federal Anti-Tampering Act ................................................22-3, 22-6Federal Cigarette Labeling and Advertising Act (FCLAA) ............ 14-15Federal Fair Packaging and

Labeling Act (FPLA) ...................................... 13-3, 13-24, 13-54,............................................................. 16-2, 16-14, 16-15, 16-16

Federal False Claims Act ............................... 4-19, 19-4, 19-49, 22-8Federal Insecticide, Fungicide and Rodenticide Act ....................... 1-7Federal Meat Inspection Act (FMIA) .............. 13-3, 13-5, 13-6, 13-21,

.......................................13-24, 13-48, 13-49, 13-53, 13-66, 15-11Federal Penalties Inflation Adjustment Act

Improvements Act of 2015 ................................................... 4-30

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Federal Trade Commission Act (FTC Act) ............................1-7, 4-3,........................................................................ 5-23, 13-24, 16-19

Food Allergen Labeling and Consumer Protection Act of2004 (FALCPA) ................................................................... 13-26

Food and Drug Administration Modernization Act of1997 (FDAMA) ........................ 1-4, 7-3, 8-47, 10-3, 11-3, 22-31

§ 113 ................................................................................. 8-47§ 114 ............................................................................... 18-11

Food and Drug Administration Safety andInnovation Act (FDASIA) ...... 1-5, 1-18, 8-44, 8-62, 18-25, 21-8

§ 606 ................................................................................. 8-42Food Safety Modernization Act of 2011 (FSMA) .................1-4, 1-17,

.................................................13-8, 13-12, 13-16, 13-35, 13-36,

................................................13-37, 13-40, 13-46, 13-64, 15-11§ 419 ............................................................................... 13-18

Fox Television Stations, Inc. ...................................................... 22-33Freedom of Information Act (FOIA) .......... 4-15, 21-18, 21-21, 21-22FTC Act .................. 1-7, 4-3, 4-4, 4-6, 4-9, 4-28, 5-21, 16-19, 16-20

§ 5 ....................................................................................... 1-7§ 5(a) ............................................................................... 14-15§ 5(a)(1) ........................................................................... 12-10§ 18 ................................................................................... 5-23

Generic Drug Enforcement Act of 1992 (GDEA) ........................ 1-21Hatch-Waxman Act ....................................................................... 1-4Health Care and Education Reconciliation Act of 2010 ............... 4-18Health Insurance Portability and Accountability Act

(HIPAA) .............................................. 8-28, 12-14, 22-11, 22-16§ 248 ............................................................................... 22-10

Health Omnibus Programs Extension Act .................................. 8-47Infant Formula Act ...............................................................1-4, 21-7Inspector General Act of 1978 .................................................... 22-7Lanham Act ............................................................ 5-24, 16-2, 16-22Mail Fraud Act ...................................................................3-12, 3-14Medicare Prescription Drug Improvement and

Modernization Act of 2003 ................................................ 19-16Minor Use and Minor Species Animal Health Act of 2004 ........ 15-30MUMS Act .....................................................................15-30, 15-31National Research Act ................................................................... 8-3Nutrition Labeling and Education Act of 1990 ...........1-4, 4-28, 13-26OIG Guidelines for Evaluating State False Claims Acts

(Mar. 15, 2013) ..................................................................... 4-29Orphan Drug Act ...............................................................1-4, 15-31Patient Protection and Affordable Care Act ............ 4-18, 13-30, 19-5Pediatric Research Equity Act (PREA) .......................................... 8-64Physician Payments Sunshine Act ............................................. 19-22



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Poultry Product Inspection Act (PPIA) ......... 13-3, 13-5, 13-21, 13-24,..................................................13-48, 13-49, 13-53, 13-66, 15-11

Prescription Drug Manufacturing Act of 1987 ............................ 3-10Prescription Drug Marketing Act of 1987 .......................3-10, 19-18,

....................................................................................19-36, 22-4Public Health Safety Act (PHS Act) ........................................... 13-11

§ 311 ............................................................................... 13-11§ 361 ............................................................................... 13-11§ 369 ............................................................................... 13-11

Public Health Security and Bioterrorism Preparedness andResponse Act of 2002 ............................................................. 1-4

Public Health Service Act (PHSA) ....................................13-64, 22-3§ 351 ........................................................................12-3, 18-2§ 402 ................................................................................. 8-47

Pure Food and Drugs Act§§ 3–5 ................................................................................ 22-3

Racketeer Influenced and Corrupt Organizations Act(RICO) ................................................ 3-13, 13-14, 19-36, 19-53

Reauthorization Act of 2005 ....................................................... 17-7Safe Medical Devices Act ............................................ 9-4, 10-2, 11-3Sarbanes-Oxley Act of 2002 ........................................................ 20-7Social Security Act (SSA) ........................................................... 22-29

§ 1876(g) .......................................................................... 19-10§ 1903(m) ........................................................................ 19-10

State Food, Drug, and Cosmetic Acts ......................................... 4-27Sunscreen Innovation Act ..................................................5-14, 5-15Sunshine Act ...................................................... 19-22, 19-24, 19-37Tariff Act ...........................................................................4-26, 13-25Trade Agreements Act of 1979 .................................................... 4-22Uniform FD&C Act .................................................................. 13-63USA Patriot Improvement and Reauthorization Act of 2005 ....... 17-7Virus-Serum-Toxin Act of 1913 ......................................15-17, 15-19Wiley Act ....................................................................................... 6-3Wire Fraud Act ...................................................................3-12, 3-14

Food, Drug, and Cosmetic Actgenerally ....... 1-3, 1-4, 1-5, 1-6,

......... 1-7, 1-8, 1-10, 1-11,

..... 1-13, 1-14, 1-15, 1-20,

......... 1-23, 1-25, 2-2, 2-3,

...2-5, 2-7, 2-9, 2-10, 2-14,

...... 2-15, 2-16, 2-19, 2-23,

.......3-2, 3-3, 3-4, 3-5, 3-6,

............ 3-7, 3-8, 3-9, 3-10,

...... 3-11, 3-12, 3-13, 3-14,

...... 3-15, 3-16, 3-17, 4-24,

...... 4-26, 4-27, 4-28, 4-33,

.....4-34, 5-2, 5-3, 5-4, 5-7,

........ 5-8, 5-13, 5-14, 5-16,

...... 5-17, 5-18, 5-20, 5-23,

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............ 6-3, 6-4, 6-6, 6-18,

.....6-28, 7-2, 7-3, 7-4, 7-5,

........ 7-7, 7-12, 7-14, 7-16,

...... 7-18, 7-20, 7-26, 7-27,

.......... 8-4, 8-8, 8-55, 8-59,

...... 8-62, 8-69, 9-5, 10-12,

........... 10-12, 10-13, 12-2,

.... 12-6, 12-9, 12-28, 13-3,

...... 13-4, 13-5, 13-8, 13-9,

......... 13-11, 13-15, 13-16,

......... 13-20, 13-21, 13-23,

......... 13-24, 13-25, 13-26,

......... 13-27, 13-29, 13-30,

......... 13-33, 13-34, 13-35,

......... 13-37, 13-38, 13-39,

......... 13-42, 13-43, 13-44,

......... 13-45, 13-46, 13-52,

......... 13-54, 13-57, 13-61,

......... 13-62, 13-63, 13-66,

...... 14-2, 14-3, 14-4, 14-7,

........... 14-8, 14-14, 14-22,

......... 14-23, 14-24, 14-25,

...... 15-2, 15-4, 15-5, 15-9,

......... 15-10, 15-11, 15-12,

......... 15-15, 15-17, 15-19,

......... 15-20, 15-24, 15-25,

........... 15-29, 15-31, 16-2,

...... 16-3, 16-4, 16-5, 16-9,

......... 16-10, 16-12, 16-13,

......... 16-14, 16-15, 16-17,

......... 16-19, 16-20, 16-21,

.... 16-22, 18-2, 18-3, 18-4,

........... 18-5, 18-11, 18-14,

......... 18-21, 18-22, 18-23,

........... 18-28, 18-30, 19-4,

......... 19-55, 19-56, 19-57,

............. 19-58, 20-3, 21-4,

...... 21-5, 21-6, 21-7, 21-8,

........... 21-9, 21-11, 21-12,

........... 21-14, 21-18, 22-3,

............. 22-7, 22-9, 22-30,

......................22-31, 22-32§ 201(f) ......... 13-4, 13-61, 15-3§ 201(ff)(1) ..............13-5, 15-15

§ 201(ff)(2) ......................... 13-5§ 201(ff)(3)(B) ..................... 13-5§ 201(g) .....................14-3, 18-2§ 201(g)(1) .... 13-27, 15-3, 15-4§ 201(g)(1)(B)–(C) ............ 16-17§ 201(g)(1)(C) ................... 13-30§ 201(g)(1)(D) ...................... 6-6§ 201(h) ......... 12-2, 12-3, 12-4,

............... 14-3, 15-3, 21-9§ 201(i) ...................16-3, 16-17§ 201(k) ...................1-9, 13-25,

.......................16-13, 18-5§ 201(m) ....................1-9, 13-8,

........... 13-25, 16-14, 18-5§ 201(n) ..................1-10, 13-25§ 201(nn) ................15-4, 15-31§ 201(oo) ................15-4, 15-31§ 201(p) ............................... 5-3§ 201(p)(1) ........................... 5-4§ 201(p)(2) ......................... 5-13§ 201(qq)(1) ..................... 13-26§ 201(rr) ............................. 14-3§ 201(s) ................13-20, 13-21,

........... 13-22, 14-4, 15-13§ 201(s)(6) ........................ 13-23§ 201(t)(1) ........................ 13-21§ 201(t)(1)(B) ...................... 16-7§ 201(t)(2) ...............13-22, 16-7§ 201(v) .......... 15-2, 15-4, 15-9§ 201(w) ........................... 15-10§ 201(z) .............................. 13-4§ 301 ................... 1-8, 2-7, 3-3,

............. 3-4, 3-5, 3-8, 3-9,

....... 3-10, 3-11, 3-17, 5-2,

.......... 13-8, 13-20, 13-42,

............. 15-25, 16-4, 22-3§ 301(a) ............. 1-8, 3-17, 5-4,

.............. 6-3, 13-9, 13-45,

............ 15-3, 15-5, 15-11,

........................16-4, 18-3,

.....................18-21, 18-28§ 301(a)–(d) .............13-8, 13-25§ 301(b) ....................1-8, 15-11§ 301(c) .......................1-8, 13-9



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§ 301(cc) .......................... 13-47§ 301(d) .....................1-8, 3-17,

......... 13-32, 13-45, 18-28§ 301(dd) ................13-8, 13-32§ 301(e) ................13-32, 13-33,

.......................13-34, 21-6§ 301(ee) .................13-8, 13-46§ 301(f) ........ 1-11, 13-9, 13-34,

........... 21-6, 21-12, 21-13§ 301(g) .............................. 13-8§ 301(h) ........................... 13-45§ 301(jj) ............................. 8-55§ 301(k) ........ 13-8, 13-9, 15-11§ 301(ll) ...... 2-10, 13-19, 13-20§ 301(ll)(2)–(4) ................. 13-20§ 301(mm) ....................... 13-33§ 301(tt)(4) ....................... 14-18§ 301(u) ............................... 3-3§ 301(xx) .......................... 13-37§ 302 ............................... 13-41§ 302(a) ............................. 2-14§ 303 .......... 3-3, 3-8, 3-9, 3-14,

........ 13-42, 13-43, 15-25,

............. 16-4, 16-15, 22-3§ 303(a) ........................3-3, 6-3§ 303(a)(1) ........... 3-3, 3-4, 3-8,

............ 3-10, 3-11, 13-42,

......... 13-44, 13-45, 18-21§ 303(a)(2) ......... 3-8, 3-9, 3-10,

........... 3-11, 13-42, 13-43§ 303(b)(1) ....... 3-10, 3-11, 3-14§ 303(b)(6) ......................... 3-11§ 303(b)(7) ......................... 3-11§ 303(c) ............................ 13-45§ 303(c)(2) ............13-44, 13-45§ 303(c)(3) ....................... 13-44§ 303(e) .............................. 3-10§ 303(e)(1) ......................... 3-11§ 303(e)(2) ......................... 3-11§ 303(f)(2) ........................ 13-37§ 303(f)(3)(A)–(B) ............... 8-55§ 303(f)(5)(B) .................... 14-24§ 303(f)(8) ........................ 14-24§ 303(f)(9) ........................ 14-23

§ 304 .............. 2-9, 2-10, 13-40§ 304(a) ............................... 2-9§ 304(a)(1) ......................... 2-10§ 304(a)(2)(A)–(C) .............. 2-10§ 304(a)(2)(D)–(E) .............. 2-10§ 304(b) ......................2-9, 2-14§ 304(g) .............................. 1-17§ 304(h) ....... 1-17, 13-39, 13-40§ 304(h)(2) ....................... 13-40§ 305 ................................. 22-5§ 306(a)(1) ......................... 1-21§ 306(a)(2) ......................... 1-21§ 306(b) ............................. 1-22§ 306(b)(1)(C) .................. 13-47§ 306(b)(3)(A) ................... 13-47§ 306(b)(3)(B) ................... 13-47§ 306(c)(2)(A)(i) .................. 1-21§ 306(c)(2)(A)(iii) ............... 1-22§ 306(c)(3)(A) ..................... 1-21§ 306(l)(2) ........................ 13-47§ 309 ........................2-7, 16-21§ 331 ................................. 2-14§ 355 ................................. 8-49§ 402 .....................13-9, 13-17,

......... 13-19, 13-20, 13-21§ 402(a)(1) ......................... 13-9§ 402(a)(2) ....................... 15-12§ 402(a)(2)(A) ................... 13-10§ 402(a)(2)(B) ................... 13-23§ 402(a)(2)(C) .................. 13-20§ 402(a)(3) ....................... 13-11§ 402(a)(4) ....................... 13-11§ 402(c) ............................ 13-22§ 402(f)(1)(A) ................... 13-23§ 402(f)(1)(B) .................... 13-24§ 402(f)(1)(C) ................... 13-24§ 402(g) .................13-11, 13-15§ 403A ....................4-34, 13-63§ 403(a) ....................1-9, 13-25§ 403(e)(1) ....................... 13-25§ 403(e)(2) ....................... 13-25§ 403(i) ............................ 13-25§ 403(i)(2) ........................ 13-25§ 403(k) ........................... 13-25

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§ 403(q) ........................... 13-25§ 403(q)(5)(H) .................. 13-30§ 403(r) ............................ 13-25§ 403(r)(1)(A) ................... 13-28§ 403(r)(1)(B) ................... 13-27§ 403(r)(2)(G) ................... 13-29§ 403(r)(3)(B) ................... 13-28§ 403(r)(3)(B)–(C) ............. 13-27§ 403(r)(3)(C) ................... 13-28§ 403(r)(6) ....................... 13-29,

.....................13-30, 13-38§ 403(r)(6)(A) ................... 13-29§ 403(s) ............................ 13-27§ 403(w) ................13-17, 13-26§ 403(y) ........................... 13-27§ 404 ......................2-10, 13-13§ 408 ................................... 1-7§ 408(a)(1)–(2) ................. 13-23§ 409 ....................13-20, 13-21§ 409(a) ........................... 15-12§ 409(c)(3)(A) .................. 13-20,

.....................13-22, 15-12§ 409(h) ........................... 13-21§ 409(h)(6) ....................... 13-21§ 411(c) .............................. 13-4§ 411(c)(1)(B) ..................... 13-5§ 412 ......................13-13, 21-7§ 412(a)(3) ....................... 13-11§ 412(b) ........................... 13-11§ 413(a) ................13-19, 13-24§ 413(d) ........................... 13-24§ 414 ....................13-32, 13-34§ 414(a) ............................. 21-7§ 414(a)(1) ....................... 13-32§ 414(b) ........................... 13-34§ 414(d)(4) ....................... 13-34§ 415 ............................... 13-32§ 415(a)(3) ....................... 13-32§ 415(b)(1) ....................... 13-39§ 415(b)(2) ....................... 13-39§ 415(b)(2)–(3) ................. 13-39§ 415(b)(3) ....................... 13-39§ 415(b)(4) ....................... 13-39§ 416 ................................. 21-7§ 417 ............................... 13-33

§ 417(a)(2) ....................... 13-33§ 417(d) ........................... 13-33§ 417(d)(2) ....................... 13-33§ 418 ............................... 15-11§ 419 ............................... 13-18§ 419(a)(1)(A) ................... 13-18§ 423 ............................... 13-36§ 423(b)(1) ....................... 13-37§ 423(c) ............................ 13-37§ 423(d)(1) ....................... 13-37§ 501 ................................... 6-6§ 501(a) ....................1-10, 15-4§ 501(a)(1) ......................... 7-13§ 501(a)(2) ........................... 6-3§ 501(a)(2)(A) .................... 7-13,

.......................7-15, 15-17§ 501(a)(2)(B) ...............6-3, 6-4,

.........................7-4, 15-25§ 501(a)(5) ..............15-4, 15-25§ 501(b) ............................. 5-20§ 501(f)(1) ........................ 18-28§ 501(f)(1)(B) .................... 18-28§ 501(j) ...................21-9, 21-13§ 502 ........................1-9, 15-17§ 502(a) ....... 1-9, 12-10, 15-17,

.............. 18-3, 18-3, 18-6,

......... 18-11, 18-28, 18-30§ 502(b) ............................... 5-7§ 502(b)(1) ........................... 5-7§ 502(b)(2) ........................... 5-7§ 502(c) ................................ 5-7§ 502(e) ................................ 5-7§ 502(e)(1)(A)(iii) ............... 5-10§ 502(f) .....................5-7, 18-30§ 502(f)(1) .................7-4, 15-17,

..... 15-25, 18-3, 18-3, 18-6§ 502(n) ..................18-6, 18-15§ 502(n)(3) ....................... 18-16§ 502(o) ................18-28, 18-30§ 502(q) ........................... 18-28§ 502(r) .................18-28, 18-30§ 502(x) ............................... 5-7§ 503A ................. 7-4, 7-5, 7-8,

....... 7-9, 7-10, 7-11, 7-12,

..... 7-13, 7-14, 7-16, 7-18,


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..... 7-23, 7-24, 7-25, 7-26,

........... 7-27, 15-24, 21-11§ 503A(1)(D) ........................ 7-9§ 503A(a)(2)(b) ..................... 7-9§ 503A(b)(1)(A) .................. 7-10§ 503A(b)(1)(C) .................... 7-9§ 503A(b)(3)(A) .................... 7-9§ 503A(b)(3)(B) .................. 7-16§ 503A(c) ............................. 7-4§ 503B ............. 7-8, 7-10, 7-12,

..... 7-14, 7-18, 7-19, 7-20,

..... 7-21, 7-22, 7-23, 7-24,

....7-25, 7-26, 7-27, 15-24,

......................15-28, 21-11§ 503B(a)(2)(A)(ii) .............. 7-22§ 503B(a)(10)(A)(iii)(IX) ..... 7-26§ 503B(b)(2) ..................... 15-26§ 503B(b)(4) ....................... 7-19§ 503B(b)(4)(C)(vi) ............. 7-21§ 503B(b)(5) ....................... 7-20§ 503B(c)(2) ....................... 7-26§ 503B(d)(2) ....................... 7-25§ 503BA ............................. 7-24§ 503C(a) ......................... 18-18§ 503C(c) ......................... 18-18§ 503(b)(1)(A) ....................... 5-3§ 503(g) ............................ 15-20§ 503(g)(1) ....................... 15-20§ 503(g)(3) ....................... 15-20§ 505 ......... 2-10, 7-4, 8-4, 8-60§ 505(a) ..... 5-4, 8-7, 18-3, 18-4§ 505(a)–(b) .......................... 5-3§ 505(b)(1)(A) ....................... 8-7§ 505(b)(2) ...... 5-19, 5-19, 5-20§ 505(d) ............................. 18-7§ 505(i)(1) ............................ 8-8§ 505(i)(2) ............................ 8-8§ 505(i)(3) ............................ 8-8§ 505(i)(4) .......................... 8-24§ 505(i)(4) .......................... 8-24§ 505(o) ............................. 8-60§ 505(o)(3) ......................... 8-60§ 509 ................................. 16-3§ 510 ................................. 7-24

§ 510(h) ............................. 21-4§ 510(j) .............................. 4-24§ 510(k) ......... 8-10, 8-49, 8-55,

.......................14-8, 15-16§ 512 ........ 13-20, 15-24, 15-25§ 512(a) ............................. 15-4§ 512(a)(1) ......................... 15-4§ 512(a)(3) ......................... 15-5§ 512(a)(4) ....................... 15-27§ 512(a)(4)(A) ................... 15-30§ 512(a)(4)(A)(ii) .............. 15-30§ 512(a)(5) ....................... 15-27§ 512(b)(1) ......................... 15-6§ 512(e) .............................. 15-9§ 512(e)(1) ......................... 15-9§ 512(j) .............................. 15-5§ 512(m) .......................... 15-10§ 513(a)(1) ............15-16, 15-17§ 513(a)(1)(C) .................... 12-8§ 513(a)(2) ......................... 12-8§ 513(f)(1) .......................... 12-8§ 513(f)(2) .......................... 12-8§ 513(i)(1)(A) ..................... 12-8§ 515 .......................8-49, 14-8,

.....................15-17, 18-28§ 515(a) ............................. 12-8§ 515(c)(1)(A) ..................... 8-10§ 518 ............................... 11-10§ 518(e) .............................. 1-14§ 518(e)(1) ......................... 10-6§ 518(e)(2)(A) ..................... 10-6§ 518(e)(2)(B) ..................... 10-6§ 519 ............ 11-2, 11-3, 15-17§ 519(f) .............................. 10-2§ 519(g) ...................10-2, 11-10§ 520(f) .........................9-3, 9-4§ 520(g) .............................. 8-10§ 520(g)(3) ......................... 8-24§ 520(g)(8) ......................... 8-42§ 520(m) ............................ 8-49§ 522 ........................8-49, 8-61§ 571–73 ............................ 15-4§ 571(a)(2) ....................... 15-31§ 571(a)(2)(F) ................... 15-31

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§ 571(d) ........................... 15-32§ 571(e)(1) ....................... 15-32§ 571(h) ........................... 15-32§ 572(a)(1) ....................... 15-32§ 572(c)(2)(A) ................... 15-32§ 572(f)(1)(E) .................... 15-32§ 573(c) ............................ 15-31§ 586D(a)(1) ...................... 5-15§ 586F(a)(5) ....................... 5-14§ 601 ................................. 16-4§ 601(a) ..................16-9, 16-13§ 601(c) ............................ 16-10§ 602 ......................16-4, 16-13§ 602(a) ....................1-9, 16-14§ 602(b)(1) ....................... 16-20§ 603 ................................. 16-4§ 701(a) ........................... 13-11§ 702(a) ........................... 13-64§ 702(a)(1)(A) ................... 13-64§ 702(B) ........................... 14-20§ 703 ......................13-34, 21-6§ 703(a) ............................. 21-6§ 704 ............... 1-18, 6-25, 7-6,

............ 7-19, 13-34, 21-5,

.............. 21-6, 21-8, 21-8,

.......................21-9, 21-13§ 704(a) ........ 6-4, 21-10, 21-16§ 704(a)(1) .............1-11, 13-34,

.........................21-5, 21-8§ 704(a)(1)(B) ........13-34, 21-10§ 704(a)(2) ........................... 7-6§ 704(a)(2)(A) .................... 7-19,

.....................21-10, 21-11§ 704(a)(4) ......................... 21-8§ 705(a) ............................. 1-23§ 705(b) ............................. 1-23§ 709 ................................. 2-10§ 721 ............................... 16-13§ 721(a) ........................... 13-22§ 721(b)(5)(B) ...........13-22, 16-8§ 721(b)(5)(B)(i) .................. 16-8§ 721(b)(5)(B)(ii) ................. 16-8§ 740(d)(1)(D) .................. 15-31§ 743(a)(1)(A) ................... 13-35

§ 743(a)(1)(B) ................... 13-37§ 743(a)(2)(A) ................... 13-35§ 743(a)(2)(B) ................... 13-35§ 761 ............................... 13-33§ 761(a)(2) ....................... 13-33§ 761(e)(2) ......................... 21-7§ 801 ............................... 13-46§ 801(a) ..................1-16, 13-47§ 801(b) ............................. 1-16§ 801(e)(1) ........................... 6-9§ 801(e)(4) ......................... 6-10§ 801(l)(1) ........................ 13-32§ 801(m) .......................... 13-46§ 801(m)(1) ...........13-46, 13-47§ 801(n)(1) ....................... 13-47§ 801(q) ........................... 13-47§ 805 ............................... 13-47§ 806 ............................... 13-47§ 807(a)–(b) ........................ 21-3§ 900(1) ............................. 14-4§ 900(6) ........................... 14-14§ 901(b) ............................. 14-3§ 902 ................................. 14-4§ 902(6)(A) ......................... 14-9§ 903(a) ......................1-9, 14-5§ 903(a)(6) ......................... 14-9§ 903(b) ............................. 14-5§ 903(b)(1) ........................... 1-5§ 904(a) ........................... 14-13§ 904(b) ........................... 14-13§ 904(c) ............................ 14-14§ 905(b) ................14-13, 14-23§ 905(i) ............................ 14-13§ 905(i)(1) ........................ 14-14§ 905(i)(3) ........................ 14-13§ 905(j) .....................14-8, 14-9§ 905(j)(3) .......................... 14-8§ 905(j)(3)(ii) ...................... 14-8§ 906(d) ..... 14-11, 14-24, 14-27§ 906(d)(1) ....................... 14-15§ 906(e) .............................. 14-4§ 907(a)(1)(A) ..................... 14-7§ 907(a)(3) ......................... 14-7§ 908(a)(1) ......................... 14-5



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§ 908(c) .............................. 14-5§ 910 ................................. 14-8§ 910(a) ............................. 14-7§ 910(a)(2) ......................... 14-8§ 910(a)(3) ......................... 14-8§ 910(a)(4) ......................... 14-9§ 910(b)(1) ....................... 14-10§ 910(c)(2)(A) ................... 14-10§ 910(c)(4) ....................... 14-11§ 910(d)(1)(A) .................. 14-11§ 910(d)(1)(B)–(F) ............. 14-11§ 910(d)(3) ....................... 14-12§ 910(f)(1) ........................ 14-12§ 910(f)(2) ........................ 14-12§ 910(g) .............................. 14-8

§ 911 ............................... 14-12§ 911(b)(1) ....................... 14-12§ 911(b)(2)(A)(iii) ............. 14-12§ 911(c) ............................ 14-12§ 916(a)(2) ....................... 14-19§ 917 ................................. 14-6§ 919 ................................. 14-4§ 920(b) ........................... 14-14§ 920(b)(1) ....................... 14-14§ 920(c) ............................ 14-14§ 920(d)(1) ....................... 14-15§ 920(d)(2) ....................... 14-15§ 1002(b) ........................... 13-5§ 1003(d)(1) ......................... 1-5

Food and Drug Administration AmendmentsAct of 2007 (FDAAA)

generally .............................................1-4, 8-48, 13-20, 13-33, 15-14§ 801 .................................. 8-48, 8-49, 8-50, 8-52, 8-54, 8-55§ 901 ................................................................................. 8-60

United States CodeTITLE 7

§ 136–36y ............................ 1-7§ 2131–59 .......................... 4-14§ 2131(1) ........................... 4-14§ 2133 ............................... 4-14§ 2136 ............................... 4-14§ 7711(a) ........................... 4-15

TITLE 10

§ 1074g(f) .......................... 4-23

TITLE 15

§ 41–58 .........................1-7, 4-3§ 45 ..................................... 4-9§ 45(a) ................................. 4-3§ 45(a)(1) ......................... 16-19§ 45(b) ......................4-5, 16-20§ 46(a) ................................. 4-4

§ 49 ..................................... 4-4§ 52–55 ............................ 16-19§ 52(a)(2) ............................. 4-3§ 53(b) ................................. 4-5§ 54 ................................. 16-20§ 55(a) ................................. 4-4§ 55(b) ............................. 16-20§ 57(b) ............................. 16-20§ 1051 et seq. ...........5-24, 16-2§ 1333(a)(1) ..................... 14-15§ 1333(a)(2) ..................... 14-15§ 1333(b)(2) ..................... 14-15§ 1333(c) .......................... 14-16§ 1333(d) ......................... 14-16§ 1451 ............................. 16-14§ 1452 ............................. 16-15§ 1453(a)(1) ..................... 16-15§ 1453(a)(2) ..................... 16-15

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§ 1454(a) ......................... 16-14§ 1454(c)(3) ..................... 16-15§ 1456(a) ......................... 16-15§ 1459(a) ......................... 16-15§ 4402(a)(1) ..................... 14-15§ 4402(a)(2)(A) ................. 14-15§ 4402(b)(3) ..................... 14-16§ 4402(b)(4) ..................... 14-15

TITLE 18

§ 371 ........................3-13, 3-14§ 1001 ......................3-13, 21-6§ 1341 ......................3-12, 3-14§ 1343 ............ 3-12, 3-13, 3-14§ 1347 ....................3-13, 19-28§ 1365 ............................... 22-6§ 1505 ............................... 3-14§ 1961–1968 ...................... 3-13§ 1962 ............................... 3-13§ 1963 ......................3-13, 3-14§ 3102 ............................. 22-24§ 3103a(a) ........................ 22-24§ 3282 ......................3-12, 3-14§ 3282(a) ........................... 3-12§ 3486 ..................22-10, 22-16§ 3486(a) ......................... 22-11§ 3486(a)(1)–(3) ............... 22-11§ 3559(a)(6) ....................... 3-11§ 3571 ......................3-11, 19-5§ 3571(b)(3) ....................... 3-11§ 3571(b)(5) ....................... 3-11§ 3571(c)(3) ....................... 3-11§ 3571(c)(5) ....................... 3-11§ 3571(d) ..................3-11, 3-12§ 3751(c)(3) ....................... 3-11§ 6002 ............................. 22-15

TITLE 19

§ 1304(a) ................4-26, 13-25

TITLE 21

§ 151 ............................... 15-18§ 151–59 .......................... 15-17§ 301–399d (2012) .............. 3-3§ 301 et seq. ........................ 2-4

§ 335a(a)(1) ...................... 22-30§ 335a(a)(2) ........................ 8-72§ 335a(a)(2)(B) ................. 22-30§ 335a(b)(2) ..................... 22-30§ 335a(b)(2)(B)(ii)(I) ......... 22-30§ 335a(c)(2)(A)(ii) ............... 8-72§ 335a(c)(2)(A)(iii) .............. 8-72§ 337 ................................. 4-28§ 337a ................................ 3-16§ 351(a)(1) ........................... 7-2§ 351(b) ............................... 7-2§ 351(h) ............................... 9-2§ 352(f) .............................. 21-8§ 353 ................................. 3-10§ 353a .................................. 7-4§ 353b(d)(2) ....................... 7-25§ 355-1(b)(3) ...................... 8-60§ 355a(a)(1) ........................ 8-72§ 355c(a)(1) ........................ 8-64§ 355c(a)(2) ........................ 8-64§ 355c(a)(3)(A) ................... 8-64§ 355c(a)(3)(A)(i) ................ 8-64§ 355(k) ............................. 8-60§ 355(o) ............................. 8-60§ 355(o)(3) ......................... 8-60§ 355(o)(3)(B) ..................... 8-61§ 355(o)(3)(C) .................... 8-60§ 356b ................................ 8-59§ 356b(a)(1) ....................... 8-59§ 356b(c) ............................ 8-60§ 356(c)(1)(A) ..................... 8-63§ 356(c)(1)(B) ..................... 8-63§ 360d(a)(2)(B)(v) ............... 21-8§ 360e(d)(1)(B)(ii) ............... 21-8§ 360ee(b) .......................... 13-4§ 360j(e) ............................. 21-8§ 360j(g)(3)(A)(i) ................. 8-34§ 360j(o) .......................... 12-15§ 360k(a) ............................ 4-34§ 381 ................................. 4-24§ 453(e) .............................. 13-6§ 453(f) .............................. 13-7§ 453(g)(3)–(4) ................. 13-49§ 453(h) ........................... 13-53§ 453(h)(12) ..................... 13-48



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§ 454(a)(1) ....................... 13-66§ 454(a)(2) ....................... 13-66§ 455(c) ............................ 13-55§ 456 ....................13-49, 13-55§ 457(c) ............................ 13-53§ 463 ............................... 13-49§ 467c .............................. 13-54§ 467e .............................. 13-66§ 467f(a) ............................ 13-5§ 601(j) .............................. 13-6§ 601(m)(3)–(4) ................ 13-49§ 601(n) ........................... 13-53§ 601(n)(12) ..................... 13-48§ 601(w) ............................. 13-6§ 601(w)(2) ........................ 13-6§ 604 ....................13-49, 13-55§ 606 ....................13-49, 13-55§ 607 ............................... 13-49§ 607(d) ........................... 13-53§ 608 ............................... 13-49§ 621 ............................... 13-49§ 661(a)(1) ....................... 13-66§ 661(a)(2) ....................... 13-66§ 676 ............................... 13-60§ 677 ............................... 13-55§ 678 ............................... 13-66§ 711(e) .............................. 17-7§ 801 et seq. .............4-11, 17-2§ 802(34)–(35) ................... 17-4§ 812(a) ............................. 17-4§ 812(b)(1) ......................... 17-4§ 812(b)(2)–(5) ................... 17-4§ 822 ................................. 17-4§ 822(a)(1) ......................... 17-5§ 822(c)(2) ....................... 17-29§ 823 ................................. 17-4§ 823(f) .............................. 17-5§ 824(a) ........................... 17-12§ 824(c)(2)(C) .........17-13, 17-18§ 824(c)(3) ....................... 17-13§ 824(c)(5) ....................... 17-13§ 824(d) ................17-13, 17-14§ 824(d)(2) ....................... 17-13§ 828 ................................. 17-6

§ 829(a)–(b) ........................ 17-7§ 830(b)(1)(A) ................... 17-28§ 830(e) .............................. 17-7§ 841 ....................17-15, 17-16§ 842 ............................... 17-14§ 842(c)(1) ....................... 17-14§ 843 ............................... 17-15§ 853 ............................... 17-16§ 881 ............................... 17-16§ 903 ................................. 17-3§ 957 ................................. 17-4§ 1033(a)(3)–(4) ............... 13-49§ 1033(f) ............................ 13-7§ 1033(g) ............................ 13-7§ 1034(c) .......................... 13-55§ 1035 ............................. 13-55§ 1035(a) ......................... 13-49§ 1036 ..................13-52, 13-53§ 1036(a) ......................... 13-48§ 1051 ............................. 13-55§ 1052(b) ......................... 13-66

TITLE 26

§ 3121(d) ......................... 19-15§ 4191(a) ........................... 4-24§ 4191(b)(2)(A)–(C) ............ 4-24§ 4191(b)(2)(D) .................. 4-24§ 5311 ............................. 13-63

TITLE 27

§ 201 et seq. .................... 13-61§ 204(e) ............................ 13-63§ 205(e) .................13-62, 13-63§ 207 ............................... 13-63§ 215 ............................... 13-61

TITLE 28

§ 530B(a) ......................... 22-20§ 541 ................................... 2-5§ 547 ................................... 2-5

TITLE 31

§ 3729 ............................... 4-29§ 3729–3733 .................... 19-49

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§ 3729(a)(1) ..................... 19-50§ 3729(b)(1) ..................... 19-50§ 3730(b) ..................3-16, 22-8

TITLE 38

§ 8126(a) ........................... 4-21§ 8126(a)–(b) ...................... 4-21§ 8126(a)–(d) ...................... 4-22§ 8126(e)(1) ....................... 4-22§ 8126(e)(2) ....................... 4-22§ 8126(e)(3) ....................... 4-22§ 8126(h)(5) ....................... 4-22

TITLE 41

§ 8701–8707 .................... 19-20

TITLE 42

§ 243(a) ........................... 13-64§ 256b(a)(1) ....................... 4-19§ 256b(a)(2) ....................... 4-19§ 256b(a)(4) ....................... 4-19§ 262 ........................1-14, 8-49§ 263a .......................1-6, 12-11§ 282 ................................. 8-47§ 282(j)(1)(A)(i) .................. 8-49§ 282(j)(1)(A)(ix) ................ 8-50§ 282(j)(2)(C)(ii) ................. 8-50§ 282(j)(2)(D)(i) .................. 8-51§ 282(j)(2)(D)(ii) ................. 8-51§ 282(j)(3)(D)(ii)(I) ............. 8-52§ 282(j)(3)(D)(ii)(II) ............ 8-52§ 282(j)(3)(D)(iv)(III) .......... 8-52§ 282(j)(3)(E)(v)(I) ............... 8-53§ 282(j)(3)(E)(v)(I)(aa)–(cc) ... 8-53§ 282(j)(3)(E)(v)(III) ............ 8-53§ 282(j)(3)(G) ..................... 8-54§ 402(j)(5)(B) ...................... 8-54§ 300x-26(a)(2) ................ 14-20§ 300x-26(b)(2)(A) ............ 14-20§ 1320a-7(a) ............19-6, 22-30§ 1320a-7(a)(1) ................ 22-29§ 1320a-7a(a) ................... 19-19§ 1320a-7a(a)(5) ............... 19-19

§ 1320a-7a(a)(7) ................. 19-6§ 1320a-7a(i)(6) ............... 19-19§ 1320a-7a(i)(6)(A) ........... 19-20§ 1320a-7a(i)(6)(D) .......... 19-20§ 1320a-7a(i)(6)(F) ........... 19-20§ 1320a-7(b) .................... 22-30§ 1320a-7(b)(7) .................. 19-6§ 1320a-7b(b) ..................... 19-4§ 1320a-7b(b)(3) ................ 19-6§ 1320a-7b(b)(3)(E) ............ 19-7§ 1320a-7b(b)(3)(G) ......... 19-16§ 1320a-7b(f) ..................... 19-4§ 1320a-7b(g) ..........19-6, 19-51§ 1320a-7b(h) .................... 19-5§ 1320a-7(c) ..................... 22-30§ 1320a-7h ...................... 19-22§ 1320a-7h(d)(3) .............. 19-22§ 1320a-7i ....................... 19-23§ 1395nn ......................... 19-21§ 1395w-3a ...................... 19-54§ 1395w-3a(b) .................... 4-20§ 1395w-3a(c) .................... 4-20§ 1395w-3a(d)(4) ................ 4-20§ 1395w-3a(f) ..................... 4-20§ 1395w-114a ...........4-21, 19-7§ 1395w-114a(e) ................ 4-21§ 1396 et seq. .................... 4-29§ 1396h(b) ......................... 4-29§ 1396r-8 ......................... 19-54§ 1396r-8(a)(1) ................... 4-17§ 1396r-8(b)(3) ................... 4-20§ 1396r-8(b)(3)(A) .....4-19, 4-20§ 1396r-8(b)(3)(A)(iii) ......... 4-20§ 1396r-8(b)(3)(B) ............... 4-22§ 1396r-8(b)(3)(C) ............. 4-19,

.........................4-20, 4-22§ 1396r-8(c)(1) ................... 4-17§ 1396r-8(c)(1)(B)(iii) ......... 4-17§ 1396r-8(c)(1)(C) .............. 4-18§ 1396r-8(c)(2) ................... 4-18§ 1396r-8(c)(3)(B)(iii) ......... 4-18§ 1396r-8(c)(3)(C) .............. 4-18§ 1396r-8(k)(1) ................... 4-18



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Model ActsModel Rules of Prof ’l Conduct (ABA)

1.7 ................................................................................... 22-201.7(a) ............................................................................... 22-211.13(a) ............................................................................. 22-201.13(g) .............................................................................. 22-204.2 ................................................................................... 22-194.2 cmt. ...........................................................................22-20

State Codes

ArkansasArk. Code Ann.

§ 5-27-227 ....................................................................... 14-21§ 5-27-257 ....................................................................... 14-22

CaliforniaCal. Bus. & Prof. Code

§ 650 ............................................................................... 19-25§ 12601–12615.5 ...............................................................4-30§ 22958 ...........................................................................14-19

Cal. Civ. Code§ 1750–84 .......................................................................... 4-28

Cal. Health & Safety Code§ 110402 ......................................................................... 19-24§ 110665 ........................................................................... 4-27§ 119400 ......................................................................... 19-24§ 24170–24179.5 ................................................................. 8-5§ 25249.5–25249.13 .......................................................... 4-31§ 25249.7 .......................................................................... 4-31

Cal. Ordinance No.2006-217 ........................................................................ 14-20

ConnecticutConn. Gen. Stat.

§ 21a-70d ......................................................................... 19-24§ 21a-70e ......................................................................... 19-24

FloridaFla. Stat.

§ 569.101 ....................................................................... 14-19

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Fla. Stat. Ann.§ 458.331(1)(i) ................................................................. 19-25§ 817.505 ........................................................................ 19-25

HawaiiRev. Stat. Ann.

§ 712-1258 ...................................................................... 14-19

LouisianaLa. Rev. Stat. Ann.

§ 37:1285(A)(19) .............................................................. 19-25

MarylandMd. Code Ann., Bus. Reg.

§ 16-201–16-223 ............................................................. 14-19§ 16-301–16-309 ............................................................ 14-19

MassachusettsMass. Gen. Laws

§ 3 ................................................................................... 19-22§ 3(b) ............................................................................... 19-36

MinnesotaMinn. Stat.

§ 62J.23 ................................................................19-22, 19-36§ 461.20(b) ...................................................................... 14-21

NevadaNev. Rev. Stat.

§ 639.50 .......................................................................... 19-24

New YorkAdmin. Code

tit. 17§ 17-706 ......................................................................... 14-20

North CarolinaN.C. Gen. Stat.

§ 105-113.35 .................................................................. 14-21

Rhode IslandR.I. Gen. Laws

§ 5-48.1-3 ........................................................................ 19-22§ 5-48.1-3(c)(6) ................................................................ 19-36



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South CarolinaS.C. Code Ann.

§ 44-95-20–44-95-60 ....................................................... 14-19

TexasTex. Occ. Code

§ 102.001 ........................................................................ 19-25

UtahUtah Code Ann.

§ 26-57-103(1) ................................................................. 14-22

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RULES AND REGULATIONS

Code of Federal RegulationsTITLE 7

§ 319.37-4 ......................... 4-13§ 319.6–319.7-5 ................ 4-13§ 319.6–319.77-5 .............. 4-13§ 340.0(a)(2) ...................... 4-15§ 340.2(a) .......................... 4-15§ 340.6 .............................. 4-15pt. 1 ................................. 13-59

TITLE 9

§ 1.1 .................................. 4-14§ 2.30 ................................ 4-14§ 2.31(a) ............................ 4-15§ 2.38(e) ............................. 4-15§ 93.205 ............................ 4-14§ 101.2 ............................ 15-18§ 101.2(2) ........................ 15-18§ 101.3 ............................ 15-18§ 102.6 ............................ 15-18§ 105.1(a) ........................ 15-18§ 304.1 ............................ 13-48§ 304.3 .................13-48, 13-51§ 306.5 ............................ 13-59§ 310.25(a) ...................... 13-50§ 310.25(b) ...................... 13-50§ 312.2 ............................ 13-49§ 312.3 ............................ 13-49§ 317.2(l) ......................... 13-54§ 320.1(b)(11) .................. 13-54§ 320.3(a) ........................ 13-54§ 327.2 ............................ 13-60§ 381.1 .............................. 13-6§ 381.511-24 ................... 13-66§ 381.15 ............................ 13-7§ 381.16 .......................... 13-48§ 381.22 .......................... 13-51§ 381.35 .......................... 13-59§ 381.65 .......................... 13-50§ 381.94(a) ...................... 13-50

§ 381.96 .......................... 13-49§ 381.125(b) .................... 13-54§ 381.175(b)(6) ................ 13-54§ 381.177(a) .................... 13-54§ 381.187 ........................ 13-66§ 381.196 ........................ 13-60§ 381.511-24 ................... 13-66§ 412.2 ............................ 13-54§ 417.2(c)(4) .................... 13-56§ 417.4(a)(3) .................... 13-51§ 418.2 ............................ 13-57§ 418.3 ............................ 13-57§ 424.21 .......................... 13-52§ 424.21(b)(1) .................. 13-52§ 430.4 ............................ 13-51§ 500.1(a) ........................ 13-57§ 500.1(b) ........................ 13-58§ 500.1(c) ......................... 13-58§ 500.2 ............................ 13-58§ 500.3 ............................ 13-58§ 500.4 ............................ 13-58§ 500.6(i) ......................... 13-59§ 590.5 .............................. 13-7§ 590.140 ........................ 13-48§ 590.410(b) .................... 13-54§ 590.411 ........................ 13-54§ 590.411(c)–(e) ............... 13-54§ 590.412 ........................ 13-49§ 590.430–590.580 .......... 13-51§ 590.504(o) .................... 13-52§ 590.570(b) .................... 13-52§ 590.575 ........................ 13-52§ 590.910 ........................ 13-60pt. 321 ............................. 13-66pt. 332 ............................. 13-66pt. 416 ............................. 13-50pt. 417 ............................. 13-50pt. 500 ..................13-57, 13-59pt. 530–61 ......................... 13-6



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TITLE 16

§ 3.52(a) .............................. 4-5§ 3.53 .................................. 4-5

TITLE 17

§ 229.303(a)(3)(ii) ............ 20-36§ 240.12b-20 ................... 20-36

TITLE 19

§ 134.1(b) .......................... 4-26§ 134.46 ............................ 4-27§ 151.4 .....................4-24, 4-25pt. 134 ............................... 4-26

TITLE 21

§ 1.20(e) ........................... 16-15§ 1.94 .............................. 13-46§ 1.225 ............................ 13-32§ 1.227 ............................ 13-32§ 1.279 ............................ 13-46§ 1.326 ............................ 13-32§ 1.327 ............................ 13-34§ 1.327(e) ......................... 13-32§ 1.337 ............................ 13-32§ 1.345 ............................ 13-32§ 1.352 ............................ 13-32§ 1.361 .................13-32, 13-34§ 1.379(a) .......................... 1-17§ 1.379(b) .......................... 1-17§ 1.401 ............................ 13-40§ 1.402(a) ........................ 13-40§ 1.403 ............................ 13-40§ 1.405 ............................ 13-40§ 7.3(g) ....................10-2, 13-35§ 7.3(h) .............................. 10-3§ 7.3(j) ....................10-3, 13-35§ 7.3(k) .............................. 10-4§ 7.3(m) ..................10-8, 10-12§ 7.3(m)(1) ............13-26, 13-36§ 7.3(m)(2) ....................... 13-36§ 7.3(m)(3) ....................... 13-36§ 7.13 .............................. 13-45§ 7.40(c) ........................... 13-36§ 7.41 .............................. 13-35

§ 7.41(a) ............................ 10-7§ 7.42(a)(1) ........................ 10-8§ 7.42(a)(2) ........................ 10-8§ 7.42(b)(1) ........................ 10-8§ 7.42(b)(2) ........................ 10-9§ 7.45(a) ............................ 10-5§ 7.49(4)(b) ............. App. 10B-1§ 7.49(a) ............................ 10-9§ 7.49(b) .......................... 10-10§ 7.53(a) .......................... 10-10§ 7.53(b) .......................... 10-11§ 7.55(a) .......................... 10-11§ 7.55(b) .......................... 10-11§ 10.30 ................................ 9-5§ 17.9 .............................. 14-24§ 20.61 .............................. 11-6§ 20.64(d)(3) .................... 21-21§ 50.1(a) .............................. 8-5§ 50.3(k) ............................ 8-24§ 50.3(o) ............................ 8-40§ 50.20 .....................8-24, 8-25§ 50.23 .............................. 8-24§ 50.24 .............................. 8-24§ 50.25 .............................. 8-25§ 50.25(a)(1) ...................... 8-25§ 50.25(a)(2) ...................... 8-26§ 50.25(a)(3) ...................... 8-27§ 50.25(a)(4) ...................... 8-27§ 50.25(a)(5) ...................... 8-27§ 50.25(a)(6) ...................... 8-28§ 50.25(a)(7) ...................... 8-29§ 50.25(b) .......................... 8-30§ 50.25(b)(1) ...................... 8-30§ 50.25(b)(2) ...................... 8-30§ 50.25(b)(3) ...................... 8-30§ 50.25(b)(4) ...................... 8-31§ 50.25(b)(5) ...................... 8-31§ 50.25(b)(6) ...................... 8-32§ 50.25(c) ........................... 8-29§ 50.25(d) ............................ 8-5§ 50.52 .............................. 8-38§ 50.53 .............................. 8-39§ 50.54 .............................. 8-39§ 50.54(a) .......................... 8-39

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§ 50.54(b) .......................... 8-39§ 50.54(b)(1) ...................... 8-39§ 50.55(b) .......................... 8-41§ 50.55(c) ........................... 8-41§ 50.55(d) .......................... 8-41§ 50.55(e)(1) ...................... 8-41§ 50.55(e)(2) ...................... 8-42§ 50.55(f) ........................... 8-41§ 50.55(g) ........................... 8-41§ 50.56(b) .......................... 8-38§ 54.2(e) ............................. 8-56§ 54.4 .......................8-56, 8-57§ 54.4(a) ............................ 8-56§ 54.4(a)(3) ........................ 8-57§ 54.4(b) ............................ 8-57§ 54.5(b) ............................ 8-58§ 54.5(c) ............................. 8-58§ 56.101(a) .................8-5, 8-32§ 56.102(f) ........................... 8-7§ 56.102(g) ........................... 8-7§ 56.103 ............................ 8-69§ 56.103(a) ........................ 8-33§ 56.103(a)–(b) ............8-5, 8-32§ 56.104(c) ......................... 8-33§ 56.104(d) ........................ 8-33§ 56.105 ............................ 8-33§ 56.106(a) ........................ 8-34§ 56.106(c) ......................... 8-34§ 56.107(a) ........................ 8-35§ 56.107(a)–(b) ................... 8-34§ 56.107(c) ......................... 8-35§ 56.107(d) ........................ 8-35§ 56.107(e) ................8-35, 8-56§ 56.108(a) ........................ 8-35§ 56.108(b) ........................ 8-36§ 56.108(c) ................8-35, 8-36§ 56.109(a) ........................ 8-36§ 56.110(a) ........................ 8-36§ 56.110(b) ........................ 8-36§ 56.111 ............................ 8-37§ 56.111(a)(3) .................... 8-38§ 56.111(b) ........................ 8-38§ 56.111(c) ......................... 8-38§ 56.113 ............................ 8-36§ 56.114 ............................ 8-37

§ 56.115 ............................ 8-67§ 56.115(b) ........................ 8-67§ 56.120(a) ........................ 8-69§ 56.120(b) ........................ 8-69§ 70.3(g) ............................. 16-7§ 100.100 .......................... 4-30§ 101.9 ............................ 13-26§ 101.13 .......................... 13-29§ 101.17 .......................... 13-25§ 101.22(i) ....................... 13-31§ 101.30 .......................... 13-31§ 101.36 .......................... 13-27§ 101.62 .......................... 13-29§ 101.72–101.83 .............. 13-28§ 101.91 .......................... 13-31§ 101.93(f)–(g) .................. 13-29§ 101.95 .......................... 13-31§ 106.50–106.70 .............. 13-13§ 106.55(e) ....................... 13-14§ 106.96 .......................... 13-14§ 106.150 ........................ 13-14§ 107 ................................. 1-14§ 107.200 ........................ 13-36§ 108.25 .......................... 13-13§ 108.35 .......................... 13-13§ 109.3(c) ......................... 13-10§ 109.3(d) .......................... 13-9§ 109.30 .......................... 13-10§ 110.19(a) ...................... 13-12§ 110.35(c) ......................... 1-12§ 110.93 .......................... 13-12§ 111.75(a)(1) .................. 13-15§ 111.610 .......................... 21-7§ 112.2 ............................ 13-18§ 113.10 .......................... 13-13§ 114.10 .......................... 13-13§ 115.50 .......................... 13-12§ 117.4 ............................ 13-17§ 117.126 ........................ 13-16§ 117.130 ........................ 13-16§ 117.135 ........................ 13-17§ 117.145–117.155 .......... 13-17§ 117.170 ........................ 13-17§ 117.170(f) ..................... 13-17§ 120.5 ............................ 13-15



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§ 120.9 ............................ 13-15§ 120.14 .......................... 13-15§ 123.5 ............................ 13-15§ 123.6(b) .......................... 1-12§ 123.6(g) ......................... 13-15§ 123.12 .......................... 13-15§ 170.3(l) ..............13-21, 15-11§ 170.3(n)(2) .................... 13-61§ 170.30(b) ...................... 13-22§ 170.39 .......................... 13-20§ 170.100–170.106 .......... 13-21§ 172.870 .......................... 4-32§ 173.280 .......................... 4-32§ 174.6 ............................ 13-20§ 178.3297 ...................... 13-22§ 184.1257 ........................ 4-32§ 190.6 ............................ 13-24§ 201.1 ............. 4-26, 5-7, 18-6§ 201.5 ...................18-6, 18-15§ 201.57(c)(1) .................. 18-14§ 201.62 .............................. 5-7§ 201.63 ............................ 5-11§ 201.66 .............................. 5-7§ 201.66(c)(8) .................... 5-10§ 201.66(e) ........................... 5-7§ 201.66(g) ........................... 5-7§ 201.100(d)(1) .......18-6, 18-15§ 201.100(f) ..................... 18-18§ 201.128 ...... 13-27, 18-4, 18-6§ 201.315 .......................... 5-11§ 201.326 .......................... 5-11§ 201.327 .......................... 5-11§ 202.1 .............................. 18-6§ 202.1(e)(1) ...........18-7, 18-16§ 202.1(e)(2) .................... 18-18§ 202.1(e)(2)(i) ................. 18-18§ 202.1(e)(4)(ii)(c) .............. 18-8§ 202.1(e)(6) ...................... 18-4§ 202.1(e) ......................... 18-15§ 202.1(l)(1) ....................... 18-6§ 202.1(l)(2) ....................... 18-5§ 210.1(b) ............................ 6-3§ 210.2 ................................ 6-7§ 210.2(b) ............................ 6-6§ 210.2(c) ............................. 6-7

§ 210.3(b)(3) ........................ 6-9§ 210.3(b)(4) ........................ 6-6§ 211.1(a) ............................ 6-6§ 211.22 ............................ 6-13§ 211.22(a) ........................ 6-14§ 211.22(d) ........................ 6-11§ 211.25(a) ........................ 6-14§ 211.63 ............................ 6-21§ 211.67 ............................ 6-21§ 211.68 ............................ 6-21§ 211.80–211.94 .................. 6-9§ 211.80(a)–(b) ................... 6-20§ 211.82 ...................6-20, 6-21§ 211.84 ...................6-20, 6-21§ 211.84(b) ........................ 6-19§ 211.84(d)(2) .................... 6-19§ 211.89 ............................ 6-21§ 211.100 .......................... 6-17§ 211.100(a) ...................... 6-18§ 211.100(b) .............6-26, 6-27§ 211.101 .......................... 6-17§ 211.103 .......................... 6-17§ 211.110(a) ...................... 6-18§ 211.110(b)–(c) ................. 6-18§ 211.113(b) ...................... 1-12§ 211.115 .......................... 6-27§ 211.122(d) ...................... 6-22§ 211.122(e) ....................... 6-22§ 211.125(c) ....................... 6-22§ 211.130 .......................... 6-22§ 211.142 .......................... 6-23§ 211.150 .......................... 6-23§ 211.160(a) ...................... 6-26§ 211.160(b)(3) .................. 6-18§ 211.160(b)(4) .................. 6-23§ 211.165(a) .............6-18, 6-22§ 211.165(c)–(d) .........6-18, 6-23§ 211.165(e) ....................... 6-23§ 211.165(f) ..............6-18, 6-24§ 211.166 .......................... 6-23§ 211.166(b) ...................... 6-23§ 211.180(a) ...................... 6-24§ 211.180(c) ....................... 6-25§ 211.182 .......................... 6-24§ 211.184 .......................... 6-24

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§ 211.186 .......................... 6-24§ 211.188 .......................... 6-24§ 211.192 .................6-27, 6-28§ 211.194 .......................... 6-24§ 211.196 .......................... 6-24§ 211.198 .......................... 6-24§ 211.198(a) ...................... 6-27§ 211.198(b) ...................... 6-27§ 211.198(b)(2) .................. 6-27§ 216.24 ............................ 7-25§ 300.50 .............................. 5-9§ 310.200 .......................... 5-13§ 310.305 .................7-19, 7-20§ 312.2(b) .....................8-8, 8-9§ 312.3(b) ........... 8-6, 8-7, 8-13§ 312.7 .............................. 8-27§ 312.7(a) ........................ 18-13§ 312.8 .............................. 8-31§ 312.20(b) ........................ 8-42§ 312.21(a) ........................ 8-15§ 312.21(b) ........................ 8-15§ 312.21(c) ......................... 8-15§ 312.22(b) .......................... 8-8§ 312.22(c) ........................... 8-8§ 312.22(d) .......................... 8-8§ 312.23 .............................. 8-8§ 312.23(a)(5) .................... 8-17§ 312.23(a)(5)–(9) ................ 8-8§ 312.23(a)(6)(iii)(b) ........... 8-14§ 312.32 ............................ 8-18§ 312.32(a) ........................ 8-23§ 312.32(c) ......................... 8-17§ 312.33 .............................. 8-8§ 312.38(a) ........................ 8-47§ 312.38(b) ........................ 8-47§ 312.38(c) ......................... 8-47§ 312.40(b)(1) .................... 8-42§ 312.42(a) ........................ 8-42§ 312.42(b)(1)(i)–(v) ........... 8-43§ 312.42(b)(2) .................... 8-43§ 312.42(b)(3) .................... 8-44§ 312.42(b)(3)(i) ................. 8-44§ 312.42(b)(4) .................... 8-43§ 312.42(b)(4)(i)–(vii) ......... 8-44§ 312.42(c) ......................... 8-45

§ 312.42(d) ........................ 8-45§ 312.42(e) ......................... 8-45§ 312.42(f) ......................... 8-45§ 312.42(g) ......................... 8-46§ 312.44(a) ........................ 8-46§ 312.44(b)(1) .................... 8-46§ 312.44(b)(2) .................... 8-46§ 312.44(c) ......................... 8-46§ 312.44(d) ........................ 8-46§ 312.45(a) ........................ 8-46§ 312.45(e) ......................... 8-46§ 312.50 .....................8-7, 8-16§ 312.52 ............................ 8-16§ 312.52(a) ........................ 8-21§ 312.52(b) ........................ 8-21§ 312.53(a) ........................ 8-13§ 312.53(b) .......................... 8-7§ 312.53(c) ......................... 8-14§ 312.53(c)(1)(i) ................. 8-14§ 312.53(c)(1)(ii) ................ 8-14§ 312.53(c)(1)(iii)–(v) ......... 8-14§ 312.53(c)(1)(viii) ............. 8-14§ 312.53(c)(2) .................... 8-14§ 312.53(c)(3) .................... 8-14§ 312.53(c)(3)(i) ................. 8-15§ 312.53(c)(3)(ii) ................ 8-15§ 312.53(c)(4) ..........8-15, 8-20,

.........................8-56, 8-57§ 312.53(d) ........................ 8-16§ 312.55(a) ........................ 8-17§ 312.55(b) ........................ 8-17§ 312.56(a) ........................ 8-16§ 312.56(b) ........................ 8-18§ 312.56(c) ......................... 8-18§ 312.56(d) ........................ 8-19§ 312.57(a) ........................ 8-19§ 312.57(b) ........................ 8-20§ 312.57(c) ......................... 8-20§ 312.57(d) ........................ 8-20§ 312.59 ...................8-19, 8-20§ 312.60 ...................8-21, 8-24§ 312.61 ............................ 8-21§ 312.62(a) ........................ 8-22§ 312.62(b) ........................ 8-22§ 312.62(c) ......................... 8-22



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§ 312.64(a) ........................ 8-22§ 312.64(b) ........................ 8-23§ 312.64(c) ......................... 8-23§ 312.64(d) ...............8-23, 8-57§ 312.66 ...................8-23, 8-32§ 312.70 ............................ 1-20§ 312.70(a) ...............8-70, 8-71§ 312.70(a)–(b) ................... 8-70§ 312.70(b) ........................ 8-71§ 312.70(f) ......................... 8-72§ 314 ................................. 8-63§ 314.80 .......................... 20-36§ 314.81 ............................ 7-16§ 314.81(b)(2)(vii) .............. 8-64§ 314.81(b)(3) ......... App. 18A-2§ 314.81(b)(3)(i) .............. 18-13,

....................... App. 18A-3§ 314.126 .......................... 8-43§ 314.126(b) ...................... 8-43§ 314.510 .......................... 8-62§ 314.530 .......................... 8-63§ 314.550 ........................ 18-13§ 314.600 .......................... 8-63§ 314.610(b)(1) .................. 8-64§ 320.31 ............................ 8-10§ 320.31(b) ...................8-8, 8-9§ 320.31(d) .......................... 8-9§ 320.38 ............................ 8-20§ 320.63 ............................ 8-20§ 330.1(c)(2) ...................... 5-12§ 330.1(e) ........................... 5-10§ 330.1(g) ........................... 5-11§ 330.10(a)(4)(iv) ................. 5-9§ 330.10(a)(11) .................... 5-6§ 330.10(a)(12) ...........5-6, 5-12§ 330.11 ............................ 5-19§ 330.14(a) ........................ 5-13§ 330.14(e) ......................... 5-13§ 331.15 .............................. 5-9§ 341.18 ............................ 5-10§ 341.40 .............................. 5-9§ 341.78(c)(1) .................... 5-11§ 341.78(d) ........................ 5-11§ 350.60 ............................ 5-11

§ 358 ................................. 5-19§ 511.1(a)(1) ...................... 15-5§ 511.1(a)(2) ...................... 15-5§ 511.1(a)(3) ...................... 15-5§ 511.1(a)(4) ...................... 15-5§ 511.1(b)(1) ...................... 15-5§ 511.1(b)(3) ...................... 15-5§ 511.1(b)(4) ...................... 15-5§ 511.1(b)(5) ...................... 15-5§ 511.1(b)(8)(i) ................... 15-5§ 511.1(b)(8)(v) .................. 15-6§ 511.1(c) ........................... 1-20§ 514(b) ............................. 15-6§ 514.1(b)(5) ...................... 15-6§ 514.1(b)(8) ...................... 15-6§ 514.8 .............................. 15-8§ 514.8(a)(2)(iii) ................. 15-8§ 514.8(b)(2) ...................... 15-8§ 514.8(b)(3) ...................... 15-8§ 514.8(b)(4) ...................... 15-8§ 514.8(c) ........................... 15-8§ 514.80(b)(1) .................... 15-7§ 514.80(b)(2) .................... 15-7§ 514.80(b)(4)(i) ................. 15-8§ 514.80(b)(4)(iv) ............... 15-7§ 514.80(b)(4)(v) ................ 15-7§ 514.80(b)(5)(ii) ................ 15-8§ 514.80(e) ......................... 15-8§ 514.115 .......................... 15-9§ 514.115(a)–(c) ................. 15-9§ 514.115(b) ...................... 15-9§ 514.115(d) ...................... 15-9§ 516.3 ............................ 15-31§ 530.3(a) ........................ 15-30§ 530.4 ............................ 15-30§ 530.11 .......................... 15-30§ 530.11(d) ........................ 1-12§ 558.3(b)(2) ...................... 15-9§ 558.3(b)(3) ...................... 15-9§ 558.3(b)(4) .................... 15-10§ 558.4 ............................ 15-10§ 570.30(b) ...................... 15-13§ 570.203-.280 ................ 15-13§ 571.1(c) ......................... 15-12

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§ 600.22(b) ........................ 21-6§ 601 ................................. 8-63§ 601.12(f)(4) .......... App. 18A-3§ 601.40 ............................ 8-62§ 601.43 ............................ 8-63§ 601.70(a) ........................ 8-64§ 601.90 ............................ 8-63§ 601.91(b)(1) .................... 8-64§ 606.60(a) ........................ 1-12§ 700.11(a) ........................ 16-5§ 700.25 ............................ 16-5§ 700.25(b) ...................... 16-16§ 700.25(c) ....................... 16-16§ 701.1 ............................ 16-14§ 701.1(a) ........................ 16-12§ 701.2 ............................ 16-15§ 701.3(a) ........................ 16-15§ 701.3(b) ........................ 16-15§ 701.3(c) ......................... 16-15§ 701.11(b) ...................... 16-15§ 701.12 .......................... 16-15§ 701.13 .......................... 16-15§ 701.20(a) ........................ 16-3§ 710.8 ............................ 16-11§ 720.1 ............................ 16-12§ 720.2 ............................ 16-12§ 720.8(a) ........................ 16-15§ 740.10(a) ......16-5, 16-6, 16-16§ 740.11 .......................... 16-16§ 740.12 .......................... 16-16§ 740.17 .......................... 16-16§ 740.18 .......................... 16-16§ 740.19 .......................... 16-16§ 801.1 .............................. 4-26§ 801.4 .............................. 12-7§ 801.6 ............................ 18-30§ 801.109(b)(1) ................ 18-29§ 801.109(d) .................... 18-29§ 801.420 ........................ 18-28§ 801.421 ........................ 18-28§ 803.1(a) ........................ 11-19§ 803.3 ....................11-4, 11-7,

.........................11-8, 11-9§ 803.9 .............................. 11-6

§ 803.16 ............................ 11-6§ 803.17 .......................... 11-11§ 803.17(a) ...................... 11-12§ 803.17(b) ...................... 11-12§ 803.18 .......................... 11-13§ 803.18(b)(1) .................. 11-14§ 803.18(b)(1)(ii) .............. 11-15§ 803.18(c) ....................... 11-14§ 803.18(d)(1) .................. 11-19§ 803.18(d)(2) .................. 11-19§ 803.19 .......................... 11-14§ 803.19(a) ........................ 11-5§ 803.19(b) ........................ 11-5§ 803.19(c) ......................... 11-5§ 803.20(c)(1) .................... 11-7§ 803.20(c)(2) .................... 11-8§ 803.30 .......................... 11-18§ 803.30(a)(1) .................... 11-4§ 803.30(a)(2) .................... 11-5§ 803.33 ............................ 11-5§ 803.33(a) ...................... 11-19§ 803.40(a) ........................ 11-4§ 803.40(b) ........................ 11-4§ 803.50 .......................... 11-17§ 803.50(a) .............11-4, 12-10§ 803.50(b)(3) .................... 11-4§ 803.53 .......................... 11-17§ 803.56 .......................... 11-18§ 806 ...................... App. 10B-1§ 806.1 ............................ 10-12§ 806.2(i) ........................... 10-3§ 806.2(j) ........................... 12-9§ 806.2(k) .......................... 10-4§ 806.2(l) ........................... 10-4§ 806.2(m) ......................... 10-4§ 806.3(d) .......................... 10-3§ 806.3(h) .......................... 10-3§ 806.10(a) ...................... 10-11§ 806.10(b) ...................... 10-14§ 806.10(c) ....................... 10-15§ 806.10(d) ...................... 10-16§ 806.10(f) ....................... 10-13§ 806.20(b) ...................... 10-16§ 807.3(i) ................18-28, 21-8



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§ 809.3 .............................. 12-3§ 809.3(a) .......................... 12-3§ 809.10 ...............12-20, 12-21§ 809.10(c) ..............8-12, 12-26§ 809.10(c)(2)(i) ............... 12-23§ 809.10(c)(2)(ii) .............. 12-26§ 809.30 .... 12-20, 12-21, 18-28§ 809.30(b) ...................... 12-22§ 809.30(d)(1) .................. 12-21§ 809.30(d)(2) .................. 12-21§ 809.30(d)(4) .................. 12-21§ 809.30(e) ....................... 12-22§ 809.30(f) ....................... 12-22§ 810 ................................. 1-14§ 812.2(b) .......................... 8-11§ 812.2(b)(1) ...................... 8-11§ 812.2(b)–(c) ..................... 8-10§ 812.2(c) ........................... 8-13§ 812.2(c)(3) .................... 12-26§ 812.3(b) .......................... 8-13§ 812.3(h) ........................ 12-26§ 812.3(i) ............................. 8-6§ 812.3(k) ........................ 12-27§ 812.3(m) ......................... 8-10§ 812.3(n) ............................ 8-6§ 812.3(o) ............................ 8-6§ 812.3(p) ............................ 8-6§ 812.5(c) ........................... 8-12§ 812.7 .............................. 8-27§ 812.7(a) ........................ 18-31§ 812.7(b) .......................... 8-31§ 812.20 ...................8-11, 8-42§ 812.20(a) ........................ 8-11§ 812.20(a)(2) .................... 8-11§ 812.30(a) ...............8-11, 8-44§ 812.30(a)(1) .................... 8-11§ 812.30(b) ........................ 8-46§ 812.30(b)(4) .................... 8-44§ 812.30(c) ......................... 8-46§ 812.30(c)(2) ...........8-45, 8-46§ 812.40 .....................8-7, 8-16§ 812.43(a) ........................ 8-13§ 812.43(b) .......................... 8-7§ 812.43(c) ......................... 8-15§ 812.43(c)(5) ...........8-20, 8-56

§ 812.43(d) ........................ 8-16§ 812.45 ............................ 8-18§ 812.46 ............................ 8-18§ 812.46(a) ...............8-18, 8-20§ 812.46(b)(2) .................... 8-19§ 812.50(a)(1) .................... 8-18§ 812.62 ............................ 8-32§ 812.64 ............................ 8-32§ 812.100 .................8-21, 8-24§ 812.110(c) ....................... 8-21§ 812.110(d) ...................... 8-57§ 812.110(e) ..............8-19, 8-22§ 812.140(a)(2) .................. 8-22§ 812.140(a)(3) .................. 8-22§ 812.140(b) ...................... 8-19§ 812.140(b)(3) .................. 8-20§ 812.140(d) .............8-20, 8-22§ 812.150(a) .............8-22, 8-32§ 812.150(a)(1) .................. 8-23§ 812.150(a)(2) .................. 8-23§ 812.150(a)(3) .................. 8-23§ 812.150(a)(4) .........8-24, 8-32§ 812.150(a)(5) .................. 8-24§ 812.150(a)(6) .................. 8-24§ 812.150(b)(1) ..........8-18, 8-19§ 812.150(b)(2)–(3) ............. 8-18§ 812.150(b)(7) .................. 8-18§ 814.82(a)(2) .................... 8-61§ 820.1(a)(1) ...............9-4, 12-9§ 820.1(a)(2) ........................ 9-4§ 820.1(a)(3) ........................ 9-5§ 820.1(d) ............................ 9-5§ 820.1(e) ............................. 9-5§ 820.3 ................................ 9-5§ 820.3(aa) ......................... 9-18§ 820.3(b) ...............9-27, 11-12§ 820.3(c) ............................. 9-6§ 820.3(e) ........................... 9-19§ 820.3(f) ........................... 9-16§ 820.3(g) ........................... 9-16§ 820.3(h) .......................... 9-17§ 820.3(i) ........................... 9-20§ 820.3(j) ........................... 9-19§ 820.3(k) ............................ 9-6§ 820.3(l) ............................. 9-6

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§ 820.3(n) ............................ 9-8§ 820.3(o) ............................ 9-6§ 820.3(q) .......................... 9-24§ 820.3(s) ............................. 9-6§ 820.3(t) ........................... 9-12§ 820.3(u) ............................ 9-8§ 820.3(v) ............................ 9-7§ 820.3(w) ............................ 9-6§ 820.3(x) .......................... 9-24§ 820.3(y) ............................ 9-6§ 820.3(z)(1) ...................... 9-22§ 820.3(z)(2) ...................... 9-18§ 820.5 ................................ 9-7§ 820.20(a) .......................... 9-8§ 820.20(b) .......................... 9-9§ 820.20(b)(1) ...................... 9-9§ 820.20(b)(2) ...................... 9-9§ 820.20(b)(3) ...................... 9-9§ 820.20(c) ......................... 9-10§ 820.20(d) ........................ 9-11§ 820.20(e) ......................... 9-12§ 820.22 ............................ 9-12§ 820.25(a) ........................ 9-14§ 820.25(b) ........................ 9-14§ 820.30(a) ........................ 9-15§ 820.30(a)(1) .................... 9-15§ 820.30(a)(2) .................... 9-15§ 820.30(b) ........................ 9-16§ 820.30(c) ......................... 9-16§ 820.30(d) ........................ 9-16§ 820.30(e) ......................... 9-17§ 820.30(f) ......................... 9-18§ 820.30(g) ......................... 9-18§ 820.30(h) ........................ 9-18§ 820.30(i) ......................... 9-19§ 820.40 ............................ 9-27§ 820.50(a) ........................ 9-20§ 820.50(b) ........................ 9-20§ 820.60 ............................ 9-23§ 820.65 ............................ 9-26§ 820.70 ............................ 9-21§ 820.70(g) ......................... 9-21§ 820.70(i) ......................... 9-22§ 820.72 ............................ 9-22§ 820.75 ............................ 9-22

§ 820.75(a) ........................ 1-12§ 820.80 ............................ 9-22§ 820.80(e) ......................... 9-23§ 820.86 ............................ 9-23§ 820.90 ............................ 9-24§ 820.90(b)(2) .................... 9-24§ 820.100 .................6-28, 9-25§ 820.120 .......................... 9-25§ 820.130 .......................... 9-17§ 820.180 .......................... 9-26§ 820.180(a) ...................... 9-26§ 820.180(b) ...................... 9-26§ 820.180(c) ....................... 9-27§ 820.186 ............................ 9-7§ 820.198 .......................... 9-27§ 820.200 .......................... 9-28§ 820.200(c) ....................... 9-29§ 820.200(d) ...................... 9-28§ 820.250 .................9-15, 9-23§ 830.3 .............................. 9-26§ 830.20 ............................ 9-26§ 860.7(c)(2) ...........12-8, 18-31§ 864.4010 ...................... 12-31§ 864.4020 ...........12-20, 12-21§ 864.4020(b)(1) .............. 12-21§ 864.4020(b)(2) .............. 12-21§ 864.4020(b)(3) .............. 12-21§ 1004 .................... App. 10B-1§ 1140.14(a) .........14-16, 14-25§ 1140.14(b) .........14-16, 14-26§ 1140.14(b)(1) ................ 14-25§ 1140.14(b)(3) ................ 14-26§ 1140.14(c) ..................... 14-16§ 1140.14(d) .................... 14-25§ 1140.14(e) ..................... 14-16§ 1140.16(a) .................... 14-16§ 1140.16(b) .................... 14-16§ 1140.16(c) ..................... 14-16§ 1140.16(d) ................... 14-16,

.....................14-17, 14-26§ 1140.32(a) .................... 14-17§ 1140.34(a) .................... 14-17§ 1140.34(b) .................... 14-17§ 1140.34(c) ..................... 14-17§ 1143 ............................. 14-27



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§ 1143.3 .......................... 14-27§ 1143.3(c) ....................... 14-27§ 1143.5(a)(3) .................. 14-27§ 1143.5(c) ....................... 14-27§ 1271.440 ........................ 1-14§ 1301.13(e) ....................... 17-4§ 1301.36(e) ..................... 17-13§ 1301.36(f) ..................... 17-14§ 1301.36(h) .................... 17-14§ 1301.37(a) .................... 17-12§ 1301.37(c) ..................... 17-12§ 1301.41–.46 .................. 17-12§ 1301.44(e) ..................... 17-12§ 1301.44(d) .................... 17-12§ 1301.44(e) ..................... 17-12§ 1301.46 ........................ 17-13§ 1301.52(a) .................... 17-11§ 1301.71–.77 .................... 17-5§ 1301.71(a) ...................... 17-5§ 1301.71(b) ...................... 17-5§ 1301.72(a) ...................... 17-6§ 1301.72(b) ...................... 17-6§ 1301.74(b) ...........17-8, 17-23§ 1301.74(c) ....................... 17-8§ 1301.75 .......................... 17-6§ 1301.76 ........................ 17-21§ 1301.76(b) ...................... 17-8§ 1304.03 ........................ 17-14§ 1304.04(a) ...................... 17-6§ 1304.11 ........................ 17-14§ 1304.11(b)–(c) ................. 17-6§ 1304.21 ........................ 17-14§ 1304.21(a) ...................... 17-6§ 1304.22 ........................ 17-14§ 1304.33 .......................... 17-8§ 1305.03 .......................... 17-6§ 1306 ............................. 17-22§ 1306.04(a) ..................... 17-7,

.....................17-21, 17-22§ 1306.05(a) ...................... 17-7§ 1309.21(a) ...................... 17-5§ 1310.05(a)(1) .................. 17-9§ 1310.05(b)(1) .................. 17-9§ 1310.06(b) ...................... 17-6§ 1311.100(b) .................... 17-6

§ 1316.31 ........................ 17-11§ 1316.32 ........................ 17-11§ 1316.47 ........................ 17-12§ 1316.49 ........................ 17-12pt. 7 ........................10-2, 10-14pt. 16 ................................. 8-71pt. 50 ................ 8-5, 8-13, 8-37pt. 54 ................................. 8-15pt. 56 ........ 8-5, 8-13, 8-33, 8-56pt. 65 ................................. 4-26pt. 71 ................................. 16-7pt. 73 ................................. 16-8pt. 74 ................................. 16-8pt. 80 ................................. 16-7pt. 106 ..................13-12, 13-13pt. 107 ............................. 13-12pt. 111 ......... 13-12, 13-15, 21-7pt. 113 ..................13-12, 13-13pt. 114 ..................13-12, 13-13pt. 117 ..................13-16, 13-17pt. 118 ............................. 13-12pt. 120 ............................. 13-15pt. 123 ..................13-12, 13-15pt. 129 ............................. 13-12pt. 130–169 ..................... 13-31pt. 201 ............................... 18-6pt. 202 ....................18-6, 18-15pt. 210 ............................. 15-10pt. 211 .......... 6-26, 7-20, 15-10pt. 312 ........................8-5, 8-44pt. 341 ................................. 5-8pt. 520–29 ......................... 15-7pt. 558 ............................... 15-7pt. 573 ..................15-12, 15-15pt. 582 ..................15-13, 15-15pt. 584 ..................15-13, 15-15pt. 700 ............................... 16-4pt. 701 ............................... 16-4pt. 710 ....................16-4, 16-20pt. 720 ............................... 16-4pt. 740 ............................... 16-4pt. 803 ...................9-28, 10-13,

........... 11-3, 11-12, 11-18pt. 806 ...................10-3, 10-13,

.....................10-14, 11-17

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pt. 807 ............ 4-24, 8-12, 12-9pt. 810 ............................... 10-6pt. 812 ............. 8-5, 8-21, 12-26pt. 812.119 ...................... 12-26pt. 820 ............................... 12-8pt. 1300 et seq. .................. 17-2pt. 1304 ........................... 17-22pt. 1309 ............................. 17-5pt. 1311 ............................. 17-6

TITLE 26

§ 48.4191–2(a)(1) ............... 4-24§ 48.4191–2(b)(2) .............. 4-24§ 51.9 ................................ 4-24pt. 48 ................................. 4-24pt. 51 ................................. 4-24

TITLE 27

§ 4.39(a)(1) ...................... 13-62§ 4.64(a)(1) ...................... 13-62§ 5.42(a)(1) ...................... 13-62§ 5.65(a)(1) ...................... 13-62§ 7.29(a)(1) ...................... 13-62§ 7.54(a)(1) ...................... 13-62pt. 4 ................................. 13-62pt. 5 ................................. 13-62pt. 7 ................................. 13-62pt. 16 ............................... 13-62

TITLE 28

§ 0.45(j) ............................... 2-4

TITLE 32

§ 199.21(q)(1) .................... 4-23§ 199.21(q)(4) .................... 4-23

TITLE 42

§ 11.10(a) .................8-49, 8-50§ 11.24 .............................. 8-50§ 11.28(a)(2) ...................... 8-51§ 11.35(a) .......................... 8-51§ 11.35(b)(1) ...................... 8-51§ 11.35(b)(2)(i) ................... 8-51§ 11.35(b)(2)(ii) .................. 8-53

§ 11.42(b) .................8-22, 8-52§ 11.44(b)(1) .............8-52, 8-53§ 11.44(b)(2) ...................... 8-53§ 11.44(c)(1) ...................... 8-53§ 11.44(c)(2) ...................... 8-53§ 11.44(d) .......................... 8-53§ 11.44(d)–(e) ..................... 8-53§ 11.48(a) .......................... 8-54§ 11.52 .............................. 8-54§ 11.66 .............................. 8-55§ 11.66(b) .......................... 8-55§ 403.900 et seq. ............. 19-22§ 411.351 ........................ 19-21§ 414.804(a) ...................... 4-20§ 414.806 .......................... 4-20§ 414.900(b) ...................... 4-20§ 447.504 .......................... 4-18§ 447.505 .......................... 4-18§ 447.512(b) .................... 19-53§ 1001.952 ........................ 19-8§ 1001.952(a) .................. 19-17§ 1001.952(aa) ................. 19-16§ 1001.952(b) .................. 19-17§ 1001.952(c) ................... 19-17§ 1001.952(d) .................. 19-13§ 1001.952(g) ................... 19-17§ 1001.952(m) ................. 19-17§ 1001.952(h) .................... 19-8§ 1001.952(h)(4) .............. 19-10§ 1001.952(h)(5) ................ 19-9§ 1001.952(h)(5)(ii) ........... 19-9,

................................ 19-38§ 1001.952(i) ................... 19-14§ 1001.952(j) ................... 19-14§ 1001.952(j)(2) ............... 19-14§ 1001.952(k) .................. 19-16§ 1001.952(t) ................... 19-15§ 1003.101 ...................... 19-20§ 1003.102(b)(13) ............ 19-20§ 1003.110(6) .................. 19-20pt. 11 ................................. 8-49pt. 1001 ............................. 19-5pt. 1003 ............................. 19-5pt. 1008 ........................... 19-19



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TITLE 45

§ 46.101 .............................. 8-4§ 46.103(a) ........................ 8-34§ 46.103(b) ........................ 8-34§ 46.116(e) ........................... 8-5§ 46.201–46.409 .................. 8-4§ 96.130 .......................... 14-20

§ 164.512 .......................... 8-28pt. 46 ................ 8-4, 8-34, 8-37pt. 50 ................................. 8-37

TITLE 48

§ 52.203-13 ..................... 20-37

Federal Register5 Fed. Reg. 66,149

(Oct. 27, 2010) ......... 17-85 Fed. Reg. 66,150

(Oct. 27, 2010) ......... 17-842 Fed. Reg. 15,567 ........... 10-243 Fed. Reg. 31,508 ............. 9-343 Fed. Reg. 31,527 ............. 9-343 Fed. Reg. 45,013 ............. 6-443 Fed. Reg. 45,076 ............. 6-443 Fed. Reg. 55,466 ............. 5-944 Fed. Reg. 23,192 ............. 8-344 Fed. Reg. 23,193 ............. 8-344 Fed. Reg. 23,195–96 ....... 8-345 Fed. Reg. 77,043 ........ 13-21,

................................ 13-2245 Fed. Reg. 77,045 ......... 13-2245 Fed. Reg. 77,046 ......... 13-2146 Fed. Reg. 8958 .............. 8-3446 Fed. Reg. 8966 .............. 8-3446 Fed. Reg. 8967 ......8-35, 8-3646 Fed. Reg. 8969 .............. 8-3747 Fed. Reg. 14,138 ........... 16-847 Fed. Reg. 14,141 ........... 16-849 Fed. Reg. 36,326 ........... 11-352 Fed. Reg. 19,466 ......... 18-1452 Fed. Reg. 19,475 ......... 18-1455 Fed. Reg. 4729 .............. 17-855 Fed. Reg. 4730 .............. 17-856 Fed. Reg. 35,952 ........... 19-556 Fed. Reg. 35,956 ........... 19-856 Fed. Reg. 35,957 ......... 19-2256 Fed. Reg. 35,958 ........... 19-556 Fed. Reg. 35,978 ......... 19-30

56 Fed. Reg. 46,191 .......... 1-19,................................ 20-37

56 Fed. Reg. 46,194 ........... 1-1956 Fed. Reg. 46,195 ......... 20-3756 Fed. Reg. 58,754 ......... 15-2056 Fed. Reg. 67,076 ........... 22-456 Fed. Reg. 67,077 ........... 22-459 Fed. Reg. 65,372 ......... 19-1459 Fed. Reg. 65,376 ......... 19-1759 Fed. Reg. 65,377 ......... 19-1460 Fed. Reg. 63,578 ......... 11-1060 Fed. Reg. 63,585 ......... 11-1060 Fed. Reg. 63585 .......... 11-1161 Fed. Reg. 17,706 ......... 15-1561 Fed. Reg. 17,706–07 .... 15-1561 Fed. Reg. 38,806 ......... 13-5061 Fed. Reg. 44,396 ........... 14-261 Fed. Reg. 44,615 ........... 14-261 Fed. Reg. 52,602 ............. 9-461 Fed. Reg. 52,606 ............. 9-462 Fed. Reg. 7,350 ............. 19-862 Fed. Reg. 7,351 ............. 19-862 Fed. Reg. 18,938 ........ 13-22,

................................ 15-1362 Fed. Reg. 18,939 ......... 13-2262 Fed. Reg. 27,184 ......... 10-1262 Fed. Reg. 27,186 ......... 10-1262 Fed. Reg. 27,187 ......... 10-1262 Fed. Reg. 27,188 ......... 10-1262 Fed. Reg. 27,191 ........... 10-362 Fed. Reg. 62,243 ......... 12-1162 Fed. Reg. 62,249 ......... 12-1262 Fed. Reg. 62,252 ......... 12-12

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62 Fed. Reg. 64,074 ......... 19-4462 Fed. Reg. 65,049 ........... 19-863 Fed. Reg. 10,792 ......... 12-2763 Fed. Reg. 10,793 ......... 12-2763 Fed. Reg. 46,676 ........... 19-663 Fed. Reg. 60,353 ........... 8-3664 Fed. Reg. 996 ................ 7-1064 Fed. Reg. 2803 ............ 13-5164 Fed. Reg. 63,504 ........... 19-864 Fed. Reg. 63,518 ......... 19-1164 Fed. Reg. 63,527 .......... 19-8,

................................ 19-1264 Fed. Reg. 63,529 ......... 19-1164 Fed. Reg. 63,530 .......... 19-9,

................................ 19-3864 Fed. Reg. 63,552 ......... 19-1365 Fed. Reg. 1000 ............ 13-2965 Fed. Reg. 5682 ............ 17-1765 Fed. Reg. 5685–86 ...... 17-1765 Fed. Reg. 18,230 ......... 12-2765 Fed. Reg. 18,232 ......... 12-2865 Fed. Reg. 19,618 ......... 20-3765 Fed. Reg. 24,410–411

................................ 19-2065 Fed. Reg. 63,035 ........... 19-965 Fed. Reg. 63,041 ........... 19-966 Fed. Reg. 856 .............. 19-2166 Fed. Reg. 872 .............. 19-2166 Fed. Reg. 920 .............. 19-2167 Fed. Reg. 55,855 ......... 19-2067 Fed. Reg. 55,857 ......... 19-2067 Fed. Reg. 58,157 ......... 13-5167 Fed. Reg. 58,159 ......... 13-5167 Fed. Reg. 62,325 ......... 13-5168 Fed. Reg. 23,731 ........ 19-18,

.................................. 20-368 Fed. Reg. 23,733–34 .... 19-5468 Fed. Reg. 23,735 ........ 19-30,

.....................19-33, 19-4568 Fed. Reg. 23,735–36 .... 19-4368 Fed. Reg. 23,737 ......... 19-5468 Fed. Reg. 23,738 ........ 19-25,

.....................19-41, 19-4868 Fed. Reg. 23,742 ......... 19-1868 Fed. Reg. 41,386 ........... 5-14

68 Fed. Reg. 48,944 ........... 17-570 Fed. Reg. 67,490 ........... 13-770 Fed. Reg. 70,623 ......... 19-3470 Fed. Reg. 70,625 ......... 19-3571 Fed. Reg. 48,552 ........... 4-2972 Fed. Reg. 6580 .............. 17-572 Fed. Reg. 34,752 ......... 13-1572 Fed. Reg. 36,487 ......... 17-2372 Fed. Reg. 36,496 ......... 17-2472 Fed. Reg. 36,500 ......... 17-2472 Fed. Reg. 36,504 ......... 17-2373 Fed. Reg. 43,937 ......... 13-2073 Fed. Reg. 52,689 ......... 17-2774 Fed. Reg. 2358 .............. 8-3474 Fed. Reg. 2359 .............. 8-3474 Fed. Reg. 12,138 ........... 8-4974 Fed. Reg. 40,211 ......... 21-1974 Fed. Reg. 40,212 ......... 21-1974 Fed. Reg. 66,133 ......... 13-4775 Fed. Reg. 13,225 ......... 14-1675 Fed. Reg. 31,800 ......... 15-1375 Fed. Reg. 31,801 ......... 15-1375 Fed. Reg. 61,613 ........... 17-775 Fed. Reg. 66,138 ......... 17-1875 Fed. Reg. 66,148 ......... 17-1875 Fed. Reg. 66,149 .......... 17-8,

................................ 17-1375 Fed. Reg. 66,150 ........... 17-875 Fed. Reg. 66,163 ......... 17-2175 Fed. Reg. 79,383 ......... 15-2876 Fed. Reg. 17,694 ........... 17-576 Fed. Reg. 24,714 ......... 13-6676 Fed. Reg. 61,563 ......... 17-1176 Fed. Reg. 61,564 ......... 17-1177 Fed. Reg. 45,675 ......... 17-1777 Fed. Reg. 45,679 ......... 17-1777 Fed. Reg. 62,316 ......... 17-2177 Fed. Reg. 62,325 ......... 17-2177 Fed. Reg. 62,345 ........ 17-18,

................................ 17-2178 Fed. Reg. 3646 ............ 13-6178 Fed. Reg. 3707–09 ...... 13-6178 Fed. Reg. 67,985 ........... 4-3378 Fed. Reg. 72,840 .......... 7-12,

.................................. 7-25



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78 Fed. Reg. 72,841 ........... 7-1079 Fed. Reg. 7006 .............. 21-779 Fed. Reg. 8832 ............ 11-1479 Fed. Reg. 8834 ........... 11-14,

................................ 11-1579 Fed. Reg. 8835 ............ 11-1579 Fed. Reg. 11,881 ......... 13-2679 Fed. Reg. 23,142 ........... 14-379 Fed. Reg. 30,716 ........... 1-1879 Fed. Reg. 31,120 ......... 19-3479 Fed. Reg. 37,747 ........... 7-1079 Fed. Reg. 37,750 ........... 7-2379 Fed. Reg. 49,566 ......... 13-5079 Fed. Reg. 69,857 ........... 7-1879 Fed. Reg. 71,156 ......... 13-3079 Fed. Reg. 71,161 ......... 13-4379 Fed. Reg. 71,259 ......... 13-3080 Fed. Reg. 8872 .............. 7-2080 Fed. Reg. 8874 .............. 7-1680 Fed. Reg. 8875 .............. 7-1680 Fed. Reg. 8876 .............. 7-1780 Fed. Reg. 8877 .............. 7-1780 Fed. Reg. 8878 .............. 7-1780 Fed. Reg. 22,207 ........... 4-1980 Fed. Reg. 26,059 ......... 18-2380 Fed. Reg. 26,060 ......... 18-2380 Fed. Reg. 26,269 ......... 13-3780 Fed. Reg. 28,624 ......... 15-2380 Fed. Reg. 31,708 ......... 15-1080 Fed. Reg. 34,650 ........... 4-3480 Fed. Reg. 39,675 ......... 13-3080 Fed. Reg. 44,303 ......... 13-2680 Fed. Reg. 46,020 ......... 13-3580 Fed. Reg. 48,324 ........... 7-2080 Fed. Reg. 50,035 ......... 17-1780 Fed. Reg. 50,040 ......... 17-1780 Fed. Reg. 50,525 ......... 13-3780 Fed. Reg. 55,418 ......... 17-2480 Fed. Reg. 55,908 ......... 13-1680 Fed. Reg. 56,128 ......... 13-1780 Fed. Reg. 56,170 ......... 15-1180 Fed. Reg. 57,741 ........... 4-1680 Fed. Reg. 57,756 ........... 12-780 Fed. Reg. 60,918 ........... 7-2080 Fed. Reg. 65,768 ........... 7-23

80 Fed. Reg. 65,781 ........... 7-1180 Fed. Reg. 72,970–975 .... 5-1580 Fed. Reg. 74,226 ......... 13-4780 Fed. Reg. 74,332 ......... 13-4780 Fed. Reg. 74,353 ......... 13-1880 Fed. Reg. 79,776 ............. 5-980 Fed. Reg. 79,780 ............. 5-981 Fed. Reg. 5170 ....4-18, 19-5381 Fed. Reg. 5355 ............ 19-5381 Fed. Reg. 7285 ............ 13-5081 Fed. Reg. 19,069 ........... 5-1481 Fed. Reg. 20,092 ......... 13-1881 Fed. Reg. 28,974 .......... 14-4,

......... 14-16, 14-17, 14-2581 Fed. Reg. 28,975 ........ 14-25,

................................ 14-2681 Fed. Reg. 33,742 ......... 13-2681 Fed. Reg. 34,000 ......... 13-2681 Fed. Reg. 34,166 ......... 13-1881 Fed. Reg. 37,502 ...7-10, 7-1181 Fed. Reg. 44,879 ........... 7-2681 Fed. Reg. 51,449 ........... 7-1481 Fed. Reg. 54,960 ........ 13-23,

................................ 15-1381 Fed. Reg. 64,982 ........... 8-4981 Fed. Reg. 65,012 ........... 8-4981 Fed. Reg. 65,015 ........... 8-4981 Fed. Reg. 65,139 ........... 8-5081 Fed. Reg. 65,146 ........... 8-5181 Fed. Reg. 69,600 ........... 8-5081 Fed. Reg. 69,668 ........... 7-2581 Fed. Reg. 69,671 ........... 8-5081 Fed. Reg. 70,118 ........... 5-1581 Fed. Reg. 70,119 ........... 5-1581 Fed. Reg. 80,003 ........... 4-1881 Fed. Reg. 88,368 ......... 19-1681 Fed. Reg. 88,371 ......... 19-1681 Fed. Reg. 88,374 ......... 19-1681 Fed. Reg. 88,378 ......... 19-1781 Fed. Reg. 90,122 ........... 5-2181 Fed. Reg. 90,123 ........... 5-2181 Fed. Reg. 91,071 ........... 7-1281 Fed. Reg. 95,863 ........... 14-882 Fed. Reg. 1210 .............. 4-20

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82 Fed. Reg. 2193 ............. 14-3,.......................18-4, 18-28

82 Fed. Reg. 2194 .............. 14-382 Fed. Reg. 2206 ....18-4, 18-2882 Fed. Reg. 7008 .............. 4-1582 Fed. Reg. 7149 ................ 8-482 Fed. Reg. 9131 ............ 17-1482 Fed. Reg. 9134 ............ 17-1482 Fed. Reg. 13,609 .......... 12-7,

................................ 12-28

82 Fed. Reg. 13,612 ......... 12-2882 Fed. Reg. 14,319 .......... 12-7,

............. 14-3, 18-4, 18-2882 Fed. Reg. 14,490 ........... 4-1282 Fed. Reg. 14,492 ........... 4-1282 Fed. Reg. 20,825 ......... 13-3182 Fed. Reg. 41,501 ........... 13-682 Fed. Reg. 45,753 ......... 13-27

Federal Rules of Civil Procedure26 .................................... 22-1226(b)(3)(A) ........................ 20-1826(b)(3)(B) ........................ 20-1826(b)(3)(C) ....................... 20-3265(a)(1) .............................. 2-1665(a)(2) .............................. 2-1665(b)(1)(A) .......................... 2-15

65(b)(2) .............................. 2-15C(2) ................................... 2-12C(3)(a)–(b) .......................... 2-12C(3)(b)(ii) ........................... 2-12C(4) ................................... 2-13E(4)(b) ................................ 2-12

Federal Rules of Criminal Procedure6 ................. 22-9, 22-16, 22-176(e) ................................... 22-176(e)(2) .............................. 22-166(e)(2)(A) .......................... 22-166(e)(2)(vi) ......................... 22-166(e)(3)(A) .......................... 22-166(e)(3)(E) .......................... 22-166(e)(3)(E)(iv) ..................... 22-176(e)(5) .............................. 22-166(e)(5)–(6) ........................ 22-166(e)(6) .............................. 22-166(e)(7) .............................. 22-16

17 ...................................... 22-917(a) .......................22-9, 22-1617(c)(1) .............................. 22-917(c)(2) ............................ 22-1017(g) ................................. 22-1018 ...................................... 3-1541 .................................... 22-2441(b) ................................ 22-2441(c)(1)–(3) ...................... 22-2441(d)(2) ............................ 22-2441(e)(2)(A) ........................ 22-2441(f)(1)(A)–(B) .................. 22-25

Federal Rules of Evidence408 .................................. 20-37501 .......................22-11, 22-12

801(d)(2) .......................... 20-33



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FDA MATERIALS

GuidanceAnimal Compounding Guidance ..................................15-23, 15-24,

...................................................................... 15-25, 15-26, 15-28§ A(2) ............................................................................... 15-26§ A(3) ............................................................................... 15-26§ A(5) ............................................................................... 15-27§ A(6) ............................................................................... 15-27§ A(8) ............................................................................... 15-26§ A(10) ............................................................................. 15-27§ B(1) ............................................................................... 15-27§ B(3) ............................................................................... 15-27§ B(4) ............................................................................... 15-27§ B(5) ............................................................................... 15-27§ B(8) ............................................................................... 15-27§ C(1) ............................................................................... 15-27§ C(3) ............................................................................... 15-28§ C(4) ............................................................................... 15-28§ C(7) ............................................................................... 15-28§ C(8) ............................................................................... 15-28§ C(9) ............................................................................... 15-28§ C(10) ............................................................................. 15-28

Clinical Investigator Administrative Actions—Disqualification Guidance ................................. 8-70, 8-71, 8-72

Compliance Program Guidance Manual ......... 8-65, 8-66, 8-67, 8-68Guidance for Entities Considering Whether to Register as

Outsourcing Facilities ............................... 7-20, 7-21, 7-25, 7-26Guidance for FDA and Tobacco Retailers (CMP Guidance) ........ 14-24Guidance for Industry

Administrative Detention of Foods ................................. 13-40Adverse Reactions Section of Labeling for Human

Prescription Drug and Biological Products .................. 18-9Applications Covered by Section 505(b)(2) .......................... 5-19Applications for Premarket Review of

New Tobacco Products ............................................... 14-10Cell Based Products for Animal Use ............................... 15-21CGMP for Phase 1 Investigational Drugs ...........................6-7Circumstances That Constitute Delaying, Denying,

Limiting, Or Refusing a Drug Inspection ...........21-9, 21-13Compounding Animal Drugs from Bulk

Drug Substances ........................................................ 15-23Consumer-Directed Broadcast Advertisements ............... 18-17

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Contract Manufacturing Arrangements for Drugs ............ 6-19Cosmetic Good Manufacturing Practices ........................ 16-10Current Good Manufacturing Practice .............................. 7-20Demonstrating Substantial Equivalence of a

New Tobacco Product .......................................14-8, 14-10Disclosing Risk Information in Consumer-Directed

Print Advertisements ................................................. 18-16Distinguishing Liquid Dietary Supplements

from Beverages ............................................................. 13-5Distributing Scientific and Medical Publications

on Unapproved New Uses ..............................18-20, 18-32Drug Stability Guidelines .................................................. 6-23E6 Good Clinical Practice ................................................. 8-13Expedited Programs Guidance ........................................... 8-62FDAAA DTC Television Ad ............................................ 18-18Form FDA-1572 Guidance ................... 8-13, 8-14, App. 8A-1Fulfilling Regulatory Requirements for Postmarketing

Submissions of Interactive Promotional Media ......... 18-26GE Animal Guidance ...........................................15-20, 15-32Guidance for Industry, Distributing Scientific and

Medical Publications on Unapproved New Uses ........ 18-20Health Document Submission Requirements for

Tobacco Products ....................................................... 14-14Helpseeking and Other Disease Awareness

Communications ....................................................... 18-23Industry and Tobacco Retailers .......................................... 14-9Industry Supported Scientific and

Educational Activities ................................................ 18-19Information Program on Clinical Trials for Serious or

Life-Threatening Diseases and Conditions .................. 8-48Interim Policy on Compounding Using Bulk

Drug Substances .......................................................... 7-23Interim Product Reporting Guidance .......................7-18, 7-19Internet/Social Media Platforms ...................................... 18-27Investigator Responsibilities .......................................8-6, 8-28Labeling of Certain Beers ................................................. 13-62Labeling OTC Human Drug Products .........................5-7, 5-8Listing of Ingredients in Tobacco Products ...................... 14-13NADA Guidance ............................................................... 15-6Medical Device Reporting for Manufacturers .................... 11-9Medical Product Communications That Are

Consistent with the FDA required Labeling ................ 18-8Oversight of Clinical Investigations .................................. 8-16Postmarketing Studies and Clinical Trials ......................... 8-60



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Presenting Risk Information in Prescription Drug andMedical Device Promotion .............................18-12, 18-32

Process Validation Guidance ........................... 6-17, 6-18, 6-19Providing Clinical Evidence of Effectiveness for

Human Drug and Biological Products .........................18-7Q7A Good Manufacturing Practice Guidance for

Active Pharmaceutical Ingredients ................................6-6Q10 Pharmaceutical Quality System ................................6-11Quality Systems Approach to Pharmaceutical CGMP

Regulations ..................................................................6-12Questions and Answers Regarding Mandatory

Food Recall ................................................................ 13-37Registration and Product Listing for Owners and

Operators of Domestic TobaccoProduct Establishments ............................................. 14-13

Registration of Human DrugCompounding Outsourcing Facilities .......................... 7-19

Reporting Drug Sample InformationUnder Section 6004 of the Affordable Care Act ........ 19-23

Request for Quality Metrics ............................................... 6-25Responding to Unsolicited Requests for

Off-Label Information about Prescription Drugs andMedical Devices ......................................................... 18-32

Submission of Warning Plans for Cigars .........................14-27Submitting and Reviewing Complete Responses

to Clinical Holds ......................................................... 8-42Substantiation for Dietary Supplement Claims .............. 13-30Three Month Extension of Certain Tobacco

Product Compliance Deadlines Related to theFinal Deeming Rule ........................................14-26, 14-28

Time and Extent Applications for NonprescriptionDrug Products .............................................................. 5-13

Use of Electronic Informed Consent,Questions and Answers ............................................... 8-22

Using a Centralized IRB Review Processin Multicenter Clinicaltrials ........................................ 8-37

Guidance for Industry and FDA StaffCommercially Distributed Analyte Specific Reagents ...... 12-22Commercially Distributed In Vitro Diagnostic

Products Labeled for Research Use Only orInvestigational Use Only ........................................... 12-24

Drug and Device Manufacturer CommunicationsWith Payors, Formulary Committees, andSimilar Entities .......................................................... 18-11

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Enforcement Policy Concerning Certain RegulationsRestricting the Sale and Distribution of Cigarettes andSmokeless Tobacco .................................................... 14-16

Expedited Access for Premarket Approval andDe Novo Medical Devices ........................................... 8-62

Financial Disclosure by Clinical Investigators ................... 8-56Financial Disclosure Guidance ...................... 8-56, 8-57, 8-58In Vitro Diagnostic (IVD) Device Studies ....................... 12-27Procedures for Handling Post-Approval Studies Imposed

by PMA Order ............................................................. 8-61Guidance for Institutional Review Boards ................ 1-20, 8-34, 8-70Guidance for Institutions and IRBs ............................................. 8-36Guidance for IRBS ..............................................................8-26, 8-27Guidance for Pharmaceutical Manufacturers ......... 20-3, 20-7, 20-36Guidance for Sponsors and

Institutional Review Boards ................................. 8-5, 8-24, 8-55Guidance, Medical Device Reporting for Manufacturers ..... 11-5, 11-9Guidance on IDE Policies and Procedures ................................... 8-46Guidance on Pre-Approval Promotion ....................................... 18-14IDE Policies & Procedures Guidance ..................................8-46, 8-47Industry Funded Dissemination of Reference Texts .................. 18-20Information Sheet Guidance

Institutional Review Boards, Clinical Investigators, andSponsors, Clinical InvestigatorAdministrative Action ........................................1-20, 8-70

IRBs, Clinical Investigators, and Sponsors ........................ 8-10Sponsors, Clinical Investigators, and IRBs ...............8-13, 8-33

Informed Consent Information Sheet Guidance ..... 8-26, 8-27, 8-28,................................................................... 8-29, 8-30, 8-31, 8-32

OIG, Compliance Program Guidance forPharmaceutical Manufacturers ............................................. 20-3

Section 503A Guidance ............................................ 7-12, 7-13, 7-17

Manual of Compliance Policy Guides (CPG)generally ........... 2-6, 2-7, 5-10,

....... 5-20, 5-21, 5-22, 7-3,

.......... 9-13, 12-11, 12-23,

........ 13-26, 15-17, 18-20,

........ 19-24, 19-25, 19-30,

........ 19-33, 19-40, 19-43,

......... 19-45, 19-48, 19-54CPG 7.101.04 ................. 13-62CPG 7.101.05 ................. 13-62

CPG § 400.400 .................. 5-20CPG § 440.100 ................ 15-29CPG § 450.200 .................. 5-15CPG § 450.300 .........5-10, 5-15CPG § 460.200 .................... 7-4CPG § 560.200 ................ 13-26CPG § 607.100 ................ 15-17CPG § 608.400 ................ 15-23CPG § 645.100 ................ 15-19



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CPG § 7132.16 .................... 7-3CPG § 7382.830 ................ 9-13

CPG pt. II(B) ..................... 5-21

Regulatory Procedures Manual (RPM)generally ........... 1-13, 2-3, 2-6,

.................. 3-7, 3-15, 5-3,

.............. 10-5, 10-5, 13-8,

............... 16-2, 22-5, 22-6§ 4-3 .................................. 5-17§ 4-4 .................................. 5-17§ 4-4.1 ........................5-3, 16-2§ 4-7 .................................. 5-17§ 6-2-2 ............................... 2-19§ 6-2-3(1) ........................... 2-15§ 6-2-3(2) ........................... 2-16§ 6-2-3(3) ........................... 2-16§ 6-2-4(1) ..................2-16, 2-17§ 6-2-4(2) ........................... 2-20§ 6-2-5 ......................2-18, 2-20§ 6-2-6 ............................... 2-17

§ 6-2-6(1) ........................... 2-17§ 6-2-6-5 ............................ 2-12§ 6-2-9(1) ........................... 2-17§ 6-2-9(2) ........................... 2-18§ 6-2-9(3) ....................2-3, 2-18§ 6-2-14 ............................. 2-20§ 6-2-16 ............................. 2-22§ 6-5-2 ............................... 3-15§ 6-5-3 ................................. 3-7§ 6-5-10 ............................. 22-6§ 7-5-2 ............................... 10-5§ 10-8-1 ............................. 22-6§ 10-8-2 ............................. 22-6ch. 4 ........... 13-38, 16-2, 16-21ch. 6 .................................. 22-6ch. 7–10 ............................. 10-7

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#209128 TOA FDA Deskbook P2 1.

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Transcript of #209128 TOA FDA Deskbook P2 1.