PRESCRIPTION REGULATION SUMMARY CHART

**Portions of this chart are not applicable at this time due to the
Subsection 56(1) Class Exemption issued by Health Canada**

March 26, 2020: Important update regarding the novel coronavirus (COVID-19) pandemic
Updated: September 30, 2021; November 23, 2021

Health Canada has issued a Controlled Drugs and Substances Act (CDSA) subsection 56(1)
class exemption for pharmacists 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.

This exemption expires on the earliest of September 30, 2026, the date it is replaced by another
exemption, or the date it is revoked.

While this exemption is in effect,

• Pharmacists may dispense any narcotic pursuant to a written or verbal order from a
practitioner
• Pharmacists may dispense a refill of a previous narcotic or controlled drug
prescription pursuant to a written or verbal order from a practitioner
• Pharmacists may transfer prescriptions of narcotics and controlled drugs to another
pharmacist in Canada and if they have already been transferred, may be transferred
to another pharmacist
• Prescriptions for a benzodiazepine or other targeted substance that have already
been transferred, may be transferred to another pharmacist in Canada
• Prescriptions for a benzodiazepine or other targeted substance may be refilled if
more than one year has elapsed since the date it was issued by the prescriber

References:
• Health Canada Subsection 56(1) Class Exemption for Patients, Practitioners and Pharmacists
Prescribing and Providing Controlled Substances in Canada
• Prescription management by pharmacists with controlled substances
• Subsection 56(1) Class Exemption– Frequently asked questions
 PRESCRIPTION (Rx) REGULATION SUMMARY CHART
*The activities permitted by the Health Canada s.56 exemption are NOT reflected in the chart below. .
Please refer to page 1 for details.
Purchase & Sales Record
Classification Description Rx Requirements1 Refills & Transfers2
Requirements3
Narcotic Drugs Drugs listed in the Schedule to the Narcotic Control Purchase Rx Sales
E.g. buprenorphine, codeine, Regulations Written1a,b Verbal1a,c Refill Transfer
Record3e Record3f
fentanyl4, hydromorphone, - All products containing only 1 narcotic (‘straight’
ketamine, Lomotil®, methadone, narcotics)
meperidine, morphine, nabilone, - All narcotics for parenteral use
Novahistex DH®,oxycodone, - Narcotic compounds with 1 narcotic and 1 non-

See CDSA exemption

See CDSA exemption

Percocet®, Teva-Lenoltec No.4, narcotic active ingredient ✔ ✘ ✘ ✘ ✔ ✔
etc.
- All products containing any of the following 5
narcotics: diacetylmorphine (heroin), hydrocodone,
methadone, oxycodone, pentazocine
Narcotic Preparations (Verbal All combinations for non-parenteral use, containing
Rx Narcotics) only 1 narcotic (other than: diacetylmorphine (heroin),
E.g. Dimetane Expectorant C®, hydrocodone, methadone, oxycodone, pentazocine) ✔ ✔
Fiorinal® C ¼ & ½, Robitussin and 2 or more non-narcotic ingredients in recognized
AC®, Teva-Lenoltec No.2 & 3, etc. therapeutic doses
✘ ✘ ✔ ✘3g
Exempted Codeine Preparations containing codeine (up to 8 mg/solid May be sold as per NAPRA
Preparations oral dosage form, or 20 mg/30mL of liquid) and 2 or Schedule II. If dispensed
E.g. Mersyndol®, more active non-narcotic ingredients pursuant to a Rx, follow the
acetaminophen/caffeine/codeine requirements for Narcotic
8mg, etc. Preparations, above.
Controlled Drugs Part I Drugs listed in Part I of Schedule to Part G of the ✔, if Rx includes
E.g. amphetamines, Food and Drug Regulations dates for, or
dextroamphetamine, - All products containing only 1 controlled drug ✔ ✔ intervals between ✘ ✔ ✔
methylphenidate, etc. (‘straight’ controlled drugs) and all combinations refills
containing more than 1 controlled drug ✘, if verbal Rx
Controlled Drugs Part II Drugs listed in Part II of the Schedule to Part G of the
Food and Drug Regulations
E.g. butorphanol, most ✔, if Rx includes
barbiturates, nalbuphine, etc.
✔
dates for, or
✘ ✔ ✘3g
Controlled Drug Preparations All combinations containing 1 controlled drug in Part ✔ intervals between
Part II II and 1 or more non-controlled ingredient(s) in a refills
E.g. Tecnal® recognized therapeutic dose
Controlled Drugs Part III Drugs listed in Part III of the Schedule to Part G of ✔, if Rx includes
the Food and Drug Regulations
Anabolic steroids and derivatives ✔ ✔ dates for, or ✘ ✔ ✘3g
(e.g. testosterone, etc.) intervals between
refills
Benzodiazepines & Other Drugs listed in the Schedule to the Benzodiazepines
✔, refills valid if <1
Targeted Substances and Other Targeted Substances Regulations. ✔, but Rx can
year has elapsed
E.g. chlordiazepoxide, clobazam, ✔ ✔ only be ✔ ✘3g
since date Rx was
clorazepate, diazepam, transferred once
issued
lorazepam, oxazepam, etc.
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.

This is a summary. Refer to legislation for detailed information. Additional resources are available on www.ocpinfo.com. 11/2022
 PRESCRIPTION (Rx) REGULATION SUMMARY
PRESCRIPTION CHART
(Rx) REGULATION SUMMARY CHART
*The activities permitted by the Health Canada s.56 exemption are NOT reflected in the chart below. .
Please refer to page 1 for details.
1Prescription and Dispensing Record Requirements are set out in the federal Controlled Drugs and Substances Act (CDSA) and the Food and Drugs Act (FDA),
and the provincial Drug & Pharmacies Regulation Act (DPRA), the Narcotics Safety & Awareness Act (NSAA), the Safeguarding our Communities Act (Patch
for Patch Return Policy) and their respective regulations
a Dispensing Record Requirements:
• Identification number of prescription • Price charged
• Name and address of patient
• Date of dispensing • Name and address of prescriber
• Name, strength, quantity and form of drug
• Signature (authorization) of dispensing • Prescriber’s registration number*
• Manufacturer of drug
pharmacist (RPh) and pharmacy technician • Patient identification (ID) number and type*
• Directions for use (RPhT) (if applicable)
b Written prescriptions may be transmitted electronically (e.g., by fax, electronic (“e-“) prescribing software, etc.)
c Additional Verbal Prescription Record Requirements: The signature (authorization) of the pharmacy professional receiving the verbal prescription, where
different from the pharmacy professional dispensing the prescription
* Per the NSAA, prescriber registration number and patient identification number/type requirements apply to monitored drugs as defined by the Ministry of
Health, including all controlled substances and opioids
2 Where a transfer is not permitted, this includes transfers of part-fills and “logged” prescriptions
• A logged prescription is a new, unfilled prescription that is entered into the patient record (‘on hold’) and may be dispensed at a later time
• A part-fill is described as dispensing a quantity less than the total amount of drug specified by the prescriber. Any prescription can be written to direct the
dispensing of part-fills and may be used in cases where refills are not permitted (i.e. narcotic prescriptions).
3 Purchase and Prescription (Rx) Sales Record requirements are set out in the federal CDSA and FDA, the provincial Drug Interchangeability and Dispensing
Fee Act (DIDFA) and their respective regulations
e Purchase Record Requirements - 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.
f Prescription Sales Record Requirements - 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.
g Prescription sales records are not required, however, emergency sales to other pharmacists require a sales record as per Narcotic Control Regulations
s45(1)(b), Food and Drug Regulations subsection G.03.014(b), Benzodiazepines and Other Targeted Substances Regulations s55(1)(b)(ii)
4 Fentanyl patches must be dispensed according to the provincial Safeguarding our Communities Act (Patch for Patch Return Policy) and its regulations

Notes:
 Scanned original prescriptions and dispensing records must be retained for at least 10 years after the patient’s last recorded pharmacy service or at least 10
years after the day on which the patient reached/would have reached the 18 years of age, whichever is longer (DPRA; O. Reg. 264/16)
 Report an unexplained loss, theft or forged prescription (if dispensed) of a controlled substance within 10 days to the Office of Controlled Substances. See
Health Canada’s website for additional information: Loss or Theft

This is a summary. Refer to legislation for detailed information. Additional resources are available on www.ocpinfo.com. 11/2022