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Obligations of Pharmacists under the Food and Drugs Act and Food and Drug Regulations

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Contact DCVIU UVCEM

November 16, 2004

Dear Pharmacist:

Subject: Obligations of Pharmacists under the Food and Drugs Act and Food and Drug Regulations

Health Canada has completed inspections of 11 Canadian pharmacies selling prescription drugs over the Internet or other forms of distance dispensing such as mail order, to determine their compliance with Canadian Food and Drugs Act and Food and Drug Regulations. This letter is to remind you of your obligations under the Food and Drugs Act and Food and Drug Regulations.

In October 2003, prior to conducting the inspections, provincial pharmacy and medical associations, authorities, and provincial and territorial ministries of health were sent a letter from the Assistant Deputy Minister of Health Canada's Health Products and Food Branch. That letter clarified Health Canada's and the Provinces' regulatory responsibilities with respect to Internet pharmacy activities and advised that Health Canada may conduct inspections of pharmacies.

In February and March 2004, inspections were conducted to verify compliance of Canadian pharmacies selling prescription drugs via the Internet and other forms of distance-dispensing, with the Food and Drugs Act (Act) and Food and Drug Regulations (Regulations). During these inspections, the following violations of the Act and Regulations were noted;

1. Some temperature-sensitive drug products were packaged and shipped in a manner that could risk exposure of such drugs to temperatures potentially impacting the safety and effectiveness of the drug product. (Act s.11)
   
   
2. Evidence was presented of significant wholesaling activity by pharmacies which did not have the necessary Establishment Licence to act as a wholesaler.
   (Regulations C.01A.004)
   
   
3. Some pharmacies were selling prescription drugs based on prescriptions signed with electronic signatures and/or rubber stamp signatures.
   (Regulations C.01.041 (1.1) (a))

1. Temperature-Sensitive Drugs

Potential violations to Section 11 of the Act were noted in packaging and shipping of temperature sensitive drug products in a manner that could risk exposure of such drugs to temperatures outside of their recommended storage conditions; potentially impacting the safety and effectiveness of the drug product.

Section 11 of the Food and Drugs Act, read together with the definition "unsanitary conditions" in Section 2 of the Food and Drugs Act, prohibits any person from :

"...packag[ing] for sale any drug under ...such conditions or circumstances as might ....render [a drug] injurious to health"

Pharmacists are reminded that they must package and ship temperature sensitive drugs in a manner that does not risk exposure of the drugs to conditions that may impact the safety and effectiveness of the drug product. A guidance document to address the transportation of temperature sensitive drug products is anticipated to be published on the Inspectorate website in late 2004.

2. Wholesale Activity Without an Establishment Licence

There was no evidence that any of the 11 sites were engaged in any activities which would be subject to or in violation of the Food and Drug Regulations Division 1A Establishment Licencing requirements. Evidence was presented that there was significant wholesaling activity by some pharmacies supplying some of the inspected pharmacies. These supplying pharmacies did not have the required Establishment Licence to wholesale drugs. This is a violation of C.01A.004 of the Food and Drug Regulations. "Wholesale" is defined in C.01A.001 of the Food and Drug Regulations as to sell any drug listed in Schedule C or D to the Act or in Schedule F to the Regulations, a controlled drug as defined in G.01.001(1), or a narcotic as defined in the Narcotic Control Regulations, other than at retail sale, where the seller's name does not appear on the label of the drug.

C.01A.004. (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,

(a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug

An Establishment Licence is issued after a firm has been inspected and the firm has demonstrated that it has fulfilled the applicable requirements of the Good Manufacturing Practices as described in Division 2 of the Food and Drug Regulations. This requirement is necessary to ensure that products entering the drug distribution chain are adequately stored, transported, and can be effectively recalled from the market.

Pharmacies engaging in the practice of the wholesale of Schedule F drugs require an Establishment Licence. Pharmacies wishing to obtain an Establishment Licence should contact the Health Products and Food Branch Inspectorate Establishment Licencing Unit at 613-954-6790 or visit the website at
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php for information regarding how to obtain the required site licence.

3. Electronic or Rubber-Stamp Signatures

During the inspections it was observed that sale of drugs was occurring pursuant to prescriptions signed using rubber stamps or electronic prescriptions signed with electronic signatures and not supported at the time of sale by a written prescription transmitted by mail or electronic means. The use of a rubber-stamp or other means of signature which is not distinct for each transaction as the basis for a prescription order is not a valid signature and does not fulfill federal requirements. The sale of Schedule F drugs in this manner is a violation of section C.01.041(1.1)(a) of the Food and Drug Regulations.

C.01.041 (1.1) Subject to C.01.043 and C.01.046, no person shall sell a substance containing a Schedule F drug unless
(a) the sale is made pursuant to a verbal or written prescription received by the seller;

Please note that a prescription signed by a Canadian practitioner, then transmitted electronically, by faxing or scanning, and received prior to the sale of a Schedule F drug would not be a violation of section C.01.041(1.1)(a) of the Food and Drug Regulations.

Next Steps

Please be advised that activities that may be subject to provincial regulation are being addressed through communications to provincial regulatory authorities in a manner which respects federal, provincial, and constitutional laws governing the privacy and confidentiality interests of those involved.

In early 2005, another round of similar compliance inspections will be conducted to verify compliance with the Food and Drugs Act and Food and Drug Regulations. The Inspectorate may also conduct inspections of pharmacies not engaged in Internet or distance dispensing to verify compliance with the Food and Drugs Act and Regulations. Any violations of the Food and Drugs Act and Food and Drug Regulations uncovered by the current and future inspections will be addressed in accordance with the Health Products and Food Branch's Compliance and Enforcement Policy.

A summary report of the compliance inspections will be posted on Health Canada's website at:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/inspect-pharma/internet_tc-tm-eng.php

Original signed by
Diana Dowthwaite
for

Jean Lambert
Director General