Pharmaceutical Training Seminar Online Quota ApplicationsPharmaceutical Training Seminar Online...
Transcript of Pharmaceutical Training Seminar Online Quota ApplicationsPharmaceutical Training Seminar Online...
Pharmaceutical Training Seminar Online Quota Applications
UN Reporting and Quota Section [email protected]
(202) 307-7184
Why the Switch from Paper? ØOMB requested we go paperless by 2013
Ø Benefits
• Provides secure web-based database system • Verifies registration as active and current • Preloads your available drug codes, historical data • Performs calculations • Provides confirmation of receipt and status • Expedites process
21 CFR 1303 & 1315 Compliance Ø Procurement applications due by April 1
Ø Import applications due by April 1
ØManufacturing applications due by May 1 Ø Adjustments to any quota can be requested
throughout the year
ØQuantities should expressed as: l Anhydrous acid, base or alkaloid l GRAMS
Accessing Quota Applications www.deadiversion.usdoj.gov
Reporting
Quotas
Quota Applications
Enter DEA issued user name & password
Secure website
New Accounts: complete user agreement, print, sign,
& email to ODE Quota to receive corporate
administrator log-in
Corporate Administrator Login
Create New Corporate User Account
Corporate User Login
Corporate User Login Confirmation
Report Selection Menu
‘71 Convention Compliance
Must request specific isomers for:
l Amphetamine • d-amphetamine • l-amphetamine • d,l-amphetamine
l Methamphetamine • d-methamphetamine • l-methamphetamine • d,l-methamphetamine
l Tetrahydrocannabinols • Delta-9-THC • All Other Tetrahydrocannabinols
Online Quota Application “For Sale” vs. “For Conversion”
• Codeine • D-Amphetamine • D-Methamphetamine • Diphenoxylate • Hydrocodone • Morphine • Noroxymorphone • Oxycodone • Oxymorphone
Online Quota Application For Sale: substance used to manufacture
products containing same basic class which is bought from the bulk manufacturer.
- involves ~95% of the quota applications ex: Codeine (for sale) codeine/APAP For Conversion: substance used to synthesize a
different basic class. ex: Codeine (for conversion) hydrocodone
Procurement Quota Application
Quota Allotment Categories
Quota Allotment Categories ØCommercial Manufacturing
• Conversion to other substances • Dosage form
ØProduct Development • All stages leading to FDA approval
l Laboratory scale l Scale up l Exhibit l Stability
Quota Allotment Categories
ØPackaging • Packaging/Repackaging • Labeling/Relabeling
ØReplacement • Case-by-case basis for commercial mfg
ØTransfer • Bulk API • In-process material • Finished dosage units
Quota Allotment Categories
Commercial – Conversions
Commercial - Dosage Forms
Product Development
Labeling & Packaging
Replacement
Transfer
Summary
Summary
Status Report
Quota Amendments
List 1 Import quota
List 1 Import quota
List 1 Import quota