Prescription Regulation Summary Chart *

March 2020

*Portions of this chart are not applicable at this time due to the notice from Health CanadaCDSA s.56 temporary exemptions

March 26, 2020: Important update regarding the novel coronavirus (Covid-19) pandemic

Health Canada has issued practitioners and pharmacists a temporary Controlled Drugs and Substances Act (CDSA) subsection 56(1) class exemption from the provisions of:

• Subsection 31(1), and section 37 of the Narcotic Control Regulations (NCR)• Sections G.03.002 and G.03.006 of Part G of the Food and Drug Regulations (FDR)• Paragraphs 52 (c) and (d), subsection 54(1) of the Benzodiazepines and Other Targeted

Substances Regulations.

While this exemption is in effect:

• Pharmacists may dispense any narcotic pursuant to a written or verbal order from apractitioner

• Pharmacists may dispense a refill of a previous narcotic or controlled drug prescriptionpursuant to a written or verbal order from a practitioner

• Pharmacists may transfer prescriptions of narcotics and controlled drugs to anotherpharmacist in Ontario and if they have already been transferred, may be transferred toanother pharmacist

• Prescriptions for a benzodiazepine or other targeted substance that have already beentransferred, may be transferred to another pharmacist

Refer to the Health Canada’s Subsection 56(1) Class Exemption for Patients, Practitioners and Pharmacists Prescribing and Providing Controlled Substances in Canada during the Coronavirus Pandemic and related Frequently Asked Questions for further information.

OCP practice tools affected by the CDSA exemption have been updated. Please refer to the OCP website for the Novel Coronavirus (COVID-19) for Pharmacy Professionals webpage.

PRESCRIPTION REGULATION SUMMARY CHART1

Classification Description Prescription Requirements3 Refills & Transfers Purchase & Sales Records

Narcotic Drugs

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Drugs listed in the Schedule to the Narcotic Control Regulations All products containing only 1 narcotic (‘straight’ narcotics) All narcotics for parenteral use All narcotic compounds containing more than 1 narcotic All narcotic compounds containing less than 2 other non-narcotic ingredients All products containing any of the following 5 narcotics:

hydrocodone

methadone oxycodone pentazocine

Written or faxed prescription only Dispensing Record Requirements

• Name and address of patient • Name, strength, quantity and form of drug • Manufacturer of drug • Directions for use • Name and address of prescriber • Identification number of prescription • Date of dispensing • Signature (authorization) of pharmacist and

pharmacy technician (if applicable) dispensing the prescription

• Price charged • Prescriber’s Registration Number4 • Patient Identification (ID) number and type4

Refills are not permitted May be prescribed as a total quantity to be dispensed in divided portions (part-fill quantities) Transfers are not permitted, including part-fills and logged prescriptions5

Purchase Records: Maintain in the Narcotic and Controlled Drug Register, as invoices filed in chronological order, or in other record for such purposes; must be readily available for auditing purposes for at least 2 years Prescription Sales Records: Maintain in the Narcotic and Controlled Drug Register or in a computer from which a printout must be readily available for auditing purposes for at least 2 years

Narcotic Preparations

E.g. Fiorinal®-C , Fiorinal®-C , Tylenol® No.2, Tylenol® No.3, Robitussin AC®, Dimetane Expectorant C®, 292 ,®

etc. Exempted Codeine Preparations E.g. AC&C®, Mersyndol ,

Defined as Verbal PrescriptionNarcotics in the Narcotic Control Regulations All combinations containing only 1 narcotic (other than the 5 listed above) and 2 or more non-narcotic ingredients in a recognized therapeutic dose Contain codeine up to 8 mg/solid oral dosage form or 20 mg/30mL of liquid, and 2 or more active non-narcotic ingredients

Written, faxed or verbal prescription

Verbal prescriptions may be accepted and recorded by a pharmacist, or by an intern or registered pharmacy student under the direct supervision of a pharmacist. In addition to the Dispensing Record Requirements above: The signature (authorization) of the person receiving a verbal prescription, where different from the pharmacist and pharmacy technician (if applicable) dispensing the prescription Note: Exempted Codeine Preparations: • May be sold without a prescription, as per

conditions in Schedule II of NAPRA National Drug Schedules.

• When dispensed pursuant to a prescription, follow the same regulations as for Narcotic Preparations (Verbal Prescription Narcotics)

Refills are not permitted. May be prescribed as a total quantity to be dispensed in divided portions (part-fill quantities) Transfers are not permitted, including part-fills and logged prescriptions5

Purchase Records: Same as above Prescription Sales Records: Not a requirement

Controlled Drugs Part I

E.g. amphetamines, methylphenidate, dextroamphetamine, etc. Controlled Drug Preparations Part I (Currently none available in Canada)

Drugs listed in Part I of Schedule to Part G of the Food and Drug Regulations

All products containing only 1 controlled drug (‘straight’ controlled drugs) All combinations containing more than 1 controlled drug. All combinations containing 1 controlled drug in Part I, and 1 or more non-controlled ingredients in recognized therapeutic dose.

Refills permitted for written or faxed prescriptions if the prescriber has directed, at the time the prescription is issued, the number of refills anddates for, or intervals between refills. Refills not permitted for verbal prescriptions May be prescribed as a total quantity to be dispensed in divided portions (part-fill quantities) Transfers are not permitted, including part-fills and logged prescriptions5

Purchase Records: Same as above Prescription Sales Records: Maintain in Narcotic and Controlled Drug Register, or in a computer from which a printout must be readily available for auditing purposes for at least 2 years

Notes: Scanned original prescriptions and dispensing records must be retained as part of the Patient Record for 10 years from their last recorded professional pharmacy service or until 10 years after the day on which the patient reached or would have reached the age of 18 years, whichever is longer (DPRA regulations)

To report Loss, Theft, Forgery (within 10 days),contact the Office of Controlled Substances at Tel: 613-954-1541 or Fax: 613-957-0110 or E-mail:

August 2020

national_compliance_section@hc-sc.gc.ca

acetaminophen/caffeine/codeine 8 mg, Robaxacet-8 , etc.

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E.g. buprenorphine, codeine,fentanyl, hydromorphone,ketamine, Lomotil® , Marinol®,methadone2, morphine,nabilone, Novahistex DH®,oxycodone, meperidine,Percocet®, Tussionex®,Tylenol® No. 4, etc

diacetylmorphine (heroin)

(Fentanyl patches3 - refer to thePatch-For-Patch Fentanyl Return Program Fact Sheet)

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*The Health Canada s.56 exemptions are not reflected in the chart below. Please see the note on page 1.*Section 56 exemptions expire on the earliest of September 30, 2021, the date it is replaced by another exemption, or the date on which it is revoked.

1 This is a summary; refer to official legislation for detailed information 2 3 Prescription and Dispensing Record Requirements are set out in the Controlled Drugs and Substances Act (CDSA), the Food and Drugs Act (FDA), the Drug & Pharmacies Regulation Act (DPRA)

and the Narcotics Safety & Awareness Act (NSAA), the Safeguarding our Communities Act (Patch for Patch Return Policy) and their respective regulations 4 Per the NSAA, requirements apply to all controlled substances (as defined in the CDSA) and any drugs in the Monitored Drugs List as set out by the Ministry of Health and Long-term Care 5 A6 Purchase and Prescription Sales Record requirements are set out in the CDSA and the Drug Interchangeability and Dispensing Fee Act (DIDFA) and their respective regulations

logged prescription is a new, unfilled prescription that is entered into the patient record (‘on hold’) and may be dispensed at a later time

Classification Description Prescription Requirements3 Refills & Transfers Purchase & Sales Records Controlled Drugs Part II E.g. Butorphanol, most barbiturates (e.g. phenobarbital) Controlled Drug Preparations Part II E.g. Bellergal Spacetabs , Tecnal

Drugs listed in Part II of the Schedule to Part G of the Food and Drug Regulations

All combinations containing 1 controlled drug in Part II and 1 or more non-controlled ingredient(s) in a recognized therapeutic dose.

Written, faxed or verbal prescription Verbal prescriptions may be accepted and recorded by a pharmacist, or by an intern or registered pharmacy student under the direct supervision of a pharmacist. Dispensing Record Requirements

Name and address of patient Name, strength, quantity and form of

drug Manufacturer of drug Directions for use Name and address of prescriber Identification number of prescription Date of dispensing Signature (authorization) of pharmacist

and pharmacy technician (if applicable) dispensing prescription and when different, person receiving verbal prescription

Price charged Prescriber’s Registration Number4 Patient Identification (ID) number and

type4

Refills permitted if the prescriber has directed, at the time the prescription is issued, the number of refills and

May be prescribed as a total quantity to be dispensed in divided portions (part-fill quantities)

Transfers are not permitted, including part-fills and logged prescriptions5

Purchase Records: Maintain in the Narcotic and Controlled Drug Register, as invoices filed in chronological order, or in other record for such purposes; must be readily available for auditing purposes for at least 2 years Prescription Sales Records: Not a requirement

Controlled Drugs Part III

Anabolic Steroids and Derivatives (e.g. testosterone) Controlled Drug Preparations Part III (Currently none available in Canada)

Drugs listed in Part III of the Schedule to Part G of the Food and Drug Regulations

All combinations containing 1 controlled drug in Part III and 1 or more non-controlled ingredient(s) in a recognized therapeutic dose.

Refills permitted if the prescriber hasdirected, at the time the prescription is issued, the number of refills and dates for, or intervals between refills.

May be prescribed as a total quantity to be dispensed in divided portions (part-fill quantities)

Transfers are not permitted, including part-fills and logged prescriptions5

Purchase Records: Same as above Prescription Sales Records: Not a requirement

Benzodiazepines & Other Targeted Substances E.g. alprazolam, diazepam, flurazepam, lorazepam, chlordiazepoxide, clobazam, clorazepate, oxazepam, temazepam, triazolam, etc.

Drugs listed in the Schedule to the Benzodiazepines and Other Targeted Substances Regulations..

Refills permitted; valid if less than 1 year has elapsed since the day the prescription was issued

May be prescribed as a total quantity to be dispensed in divided portions (part-fill quantities) Transfers permitted except for a prescription that has already been transferred

Purchase Records: Same as above Prescription Sales Records: Only required for sales to other pharmacies

Other Prescription Drugs

All drugs listed in the Prescription Drug List (PDL) of the Food and Drug Regulations or in Schedule I of NAPRA National Drug Schedules.

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Written, faxed or verbal prescription. Verbal prescriptions may be accepted and recorded by a pharmacist, pharmacy technician, or by an intern or registered pharmacy student under the direct supervision of a pharmacist. See above for Dispensing Record Requirements.

Refills permitted Transfers of authorized refills or quantity remaining are permitted

Purchase Records: Must be readily availablefor auditing purposes for atleast 2 years

Prescription Sales Records:: Not a requirement

August 2020

dates for, or intervals between refills.

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Refer to the Opioid Policy before dispensing methadone for Methadone Maintenance Treatment (MMT) http://www.ocpinfo.com/regulations-standards/policies-guidelines/opioid-policy/

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PRESCRIPTION REGULATION SUMMARY CHART1

*The Health Canada s.56 exemptions are not reflected in the chart below. Please see the note on page 1.*Section 56 exemptions expire on the earliest of September 30, 2021, the date it is replaced by another exemption, or the date on which it is revoked.