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PRESCRIPTION REGULATION SUMMARY CHART


Classification Description Prescription Requirements3 Refills & Transfers Purchase & Sales Records6
Narcotic Drugs Drugs listed in the Schedule to Written or faxed prescription only Refills are not permitted Purchase Records:
the Narcotic Control Regulations Dispensing Record Requirements Maintain in the Narcotic and
E.g. buprenorphine, codeine, May be prescribed as a total quantity Controlled Drug Register, as
fentanyl, hydromorphone, All products containing only 1 • Name and address of patient
narcotic (‘straight’ narcotics) to be dispensed in divided portions invoices filed in chronological
ketamine, Lomotil® , Marinol®, • Name, strength, quantity and form of drug
(part-fill quantities) order, or in other record for such
methadone2, morphine, All narcotics for parenteral use • Manufacturer of drug
purposes; must be readily
nabilone, Novahistex DH®, All narcotic compounds containing • Directions for use
Transfers are not permitted, including available for auditing purposes for
oxycodone, meperidine, more than 1 narcotic • Name and address of prescriber part-fills and logged prescriptions
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at least 2 years
Percocet®, Tussionex®, • Identification number of prescription
All narcotic compounds containing
Tylenol® No. 4, etc less than 2 other non-narcotic • Date of dispensing Sales Records:
ingredients • Signature (authorization) of pharmacist and Maintain in the Narcotic and
pharmacy technician (if applicable) Controlled Drug Register or in a
All products containing any of the dispensing the prescription
following 5 narcotics: computer from which a printout
®
• Price charged must be readily available for
diacetylmorphine (heroin) • Prescriber’s Registration Number
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auditing purposes for at least 2
hydrocodone • Patient Identification (ID) number and type
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years
methadone
oxycodone
pentazocine
Narcotic Preparations Defined as Verbal Prescription Written, faxed or verbal prescription Refills are not permitted. Purchase Records:
Narcotics in the Narcotic Control Same as above
®
E.g. Fiorinal -C , Regulations Verbal prescriptions may be accepted and May be prescribed as a total quantity
® ®
Fiorinal -C , Tylenol No.2, recorded by a pharmacist, or by an intern or to be dispensed in divided portions Sales Records:
® ®
Tylenol No.3, Robitussin AC , All combinations containing only 1 registered pharmacy student under the direct
® ® narcotic (other than the 5 listed (part-fill quantities) Not a requirement
Dimetane Expectorant C , 292 , supervision of a pharmacist.
etc. above) and 2 or more non-narcotic
ingredients in a recognized Transfers are not permitted, including
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therapeutic dose In addition to the Dispensing Record part-fills and logged prescriptions
Exempted Codeine Requirements above:
Preparations Contain codeine up to 8 mg/solid oral The signature (authorization) of the person
® ®
E.g. AC&C , Mersyndol , dosage form or 20 mg/30mL of liquid, receiving a verbal prescription, where different
acetaminophen/caffeine/ and 2 or more active non-narcotic from the pharmacist and pharmacy technician
codeine 8 mg, Robaxacet-8 ®, etc. ingredients (if applicable) dispensing the prescription

Note: Exempted Codeine Preparations:


Controlled Drugs Part I Drugs listed in Part I of Schedule to • May be sold without a prescription, as per Refills permitted for written or faxed Purchase Records:
Part G of the Food and Drug conditions in Schedule II of NAPRA prescriptions if the prescriber has Same as above
E.g. amphetamines, Regulations National Drug Schedules. directed, at the time the prescription
methylphenidate, All products containing only 1 • When dispensed pursuant to a prescription, is issued, the number of refills and Sales Records:
dextroamphetamine, etc. controlled drug (‘straight’ controlled follow the same regulations as for Narcotic dates for, or intervals between refills. Maintain in Narcotic and
drugs) Preparations (Verbal Prescription Narcotics) Controlled Drug Register, or in a
All combinations containing more Refills not permitted for verbal computer from which a printout
than 1 controlled drug. prescriptions must be readily available for
May be prescribed as a total quantity auditing purposes for at least 2
to be dispensed in divided portions years
Controlled Drug All combinations containing 1 (part-fill quantities)
Preparations Part I controlled drug in Part I, and 1 or

June 2018
(Currently none available in more non-controlled ingredients in Transfers are not permitted, including
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Canada) recognized therapeutic dose. part-fills and logged prescriptions

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: national_compliance_section@hc-sc.gc.ca
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PRESCRIPTION REGULATION SUMMARY CHART
Classification Description Prescription Requirements3 Refills & Transfers Purchase & Sales Records 6
Controlled Drugs Part II Drugs listed in Part II of the Schedule Written, faxed or verbal prescription Refills permitted if the prescriber has Purchase Records:
to Part G of the Food and Drug Verbal prescriptions may be accepted and directed, at the time the prescription Maintain in the Narcotic and
E.g. Butorphanol, most Regulations recorded by a pharmacist, or by an intern or is issued, the number of refills and Controlled Drug Register, as
barbiturates (e.g. registered pharmacy student under the direct dates for, or intervals between refills. invoices filed in chronological
phenobarbital) supervision of a pharmacist. order, or in other record for such
May be prescribed as a total quantity purposes; must be readily
Dispensing Record Requirements to be dispensed in divided portions available for auditing purposes for
Controlled Drug All combinations containing 1 Name and address of patient (part-fill quantities) at least 2 years
Preparations Part II controlled drug in Part II and 1 or Name, strength, quantity and form of Transfers are not permitted, including
E.g. Bellergal Spacetabs ®, more non-controlled ingredient(s) in a drug part-fills and logged prescriptions
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Tecnal ® recognized therapeutic dose. Manufacturer of drug Not a requirement
Directions for use
Controlled Drugs Part III Drugs listed in Part III of the Schedule Name and address of prescriber Refills permitted if the prescriber has Purchase Records:
to Part G of the Food and Drug Identification number of prescription directed, at the time the prescription Same as above
Anabolic Steroids and Regulations is issued, the number of refills and
Date of dispensing
Derivatives (e.g. testosterone) dates for, or intervals between refills. Sales Records:
Signature (authorization) of pharmacist
and pharmacy technician (if applicable) Not a requirement
dispensing prescription and when May be prescribed as a total quantity
different, person receiving verbal to be dispensed in divided portions
prescription (part-fill quantities)
Controlled Drug All combinations containing 1 Price charged Transfers are not permitted, including
Preparations Part III controlled drug in Part III and 1 or 4
Prescriber’s Registration Number part-fills and logged prescriptions
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(Currently none available in more non-controlled ingredient(s) in a
Canada) Patient Identification (ID) number and
recognized therapeutic dose. type
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Benzodiazepines & Other Drugs listed in the Schedule to the Refills permitted; valid if less than 1 Purchase Records:
Targeted Substances Benzodiazepines and Other Targeted year has elapsed since the day the Same as above
Substances Regulations.. prescription was issued
E.g. alprazolam, diazepam, Sales Records:
flurazepam, lorazepam, May be prescribed as a total quantity Only required for sales to other
chlordiazepoxide, clobazam, to be dispensed in divided portions pharmacies
clorazepate, oxazepam, (part-fill quantities)
temazepam, triazolam, etc.
Transfers permitted except for a
prescription that has already been
transferred
Other Prescription Drugs All drugs listed in the Prescription Written, faxed or verbal prescription. Verbal Refills permitted Purchase Records:
Drug List (PDL) of the Food and Drug prescriptions may be accepted and recorded by Must be readily available
Regulations or in Schedule I of a pharmacist, pharmacy technician, or by an Transfers of authorized refills or for auditing purposes for at
NAPRA National Drug Schedules.. intern or registered pharmacy student under the quantity remaining are permitted least 2 years
direct supervision of a pharmacist.
Sales Records :

June 2018
See above for Dispensing Record Not a requirement
Requirements.

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This is a summary; refer to official legislation for detailed information
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Prior to dispensing methadone, refer to the Methadone Maintenance Treatment (MMT) and Dispensing Policy available at http://www.ocpinfo.com/regulations-standards/policies-guidelines/methadone2/
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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) and their respective regulations
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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
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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
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Purchase & Sales Record requirements are set out in the CDSA and the Drug Interchangeability and Dispensing Fee Act (DIDFA) and their respective regulations