Notice of Proposal to expand lists of certain products for distribution as samples and a list of certain non-prescription drugs for which testing requirements do not apply

Background

On March 13, 2020, Bill C-4 entitled the Canada-United States-Mexico Agreement Implementation Act received Royal Assent. In order to implement the Canada-United States-Mexico Agreement (CUSMA), regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were necessary for Canada to meet its commitments.

On July 1, 2020, amendments to the Food and Drugs Act, the FDR and the NHPR came into force and allow:

• the distribution of certain products to the general public under certain conditions;
• the distribution of products to a larger subset of health care practitioners; and
• importation of certain non-prescription drugs into Canada without quarantine and additional testing requirements and direct shipment of such products to retailers and wholesalers.

As part of the implementation, Health Canada established a guidance document on the distribution of drugs as samples, as well as lists of the specific non-prescription drugs and natural health products that can be distributed as samples directly to consumers:

• List A: List of Certain Natural Health Products for Distribution as Samples, and
• List D: List of Certain Non-prescription Drugs for Distribution as Samples.

Health Canada also established a list of certain non-prescription drugs for which additional (i.e., identity and confirmatory) testing is not required upon importation and that may be directly shipped to retailers or wholesalers:

• List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply

Guidance

The guidance document entitled Distributing samples of prescription drugs, non-prescription drugs and natural health products will be updated following the public comment period.

The current guidance document is available by requesting a copy from the Natural and Non-prescription Health Products Directorate via email at: hc.nnhpd.consultation-dpsnso.sc@canada.ca.

Other existing guidance documents will also be updated in response to the regulatory amendments associated with the release of certain non-prescription drugs to the Canadian market without quarantine and additional testing upon importation and direct shipment of such products to retailers and wholesalers:

• Good manufacturing practices guide for drug products (GUI-0001)
• Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Drugs (GUI-0066).

Note: GUI-0066 will apply to all products under the proposed List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply and the title of the guidance document has been changed to reflect its expanded scope.

Proposal

Health Canada intends to amend the lists for non-prescription drugs and natural health products to include all currently authorized products in the product categories set out in the CUSMA and meeting the identified criteria, i.e., for topical use, localized and non-systemic effect, and meets the definition of a cosmetic.

The product categories covered across these lists include: toothpastes, mouthwashes, anti-septic skin cleansers, sunscreens, anti-dandruff products, diaper-rash products, medicated skin care products, acne therapy products and antiperspirants, as well as athlete's foot products and throat lozenges.

This means that, within those products categories, all three lists will be expanded to include all approved ingredients, all approved quantities and all approved uses or purposes with the exception of medicated skin care products. The CUSMA does include some exclusions related to medicated skin care products (i.e., antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics), and these exclusions will be maintained for the current proposal.

The proposed lists are as follows:

Proposed list A: List of Certain Natural Health Products for Distribution as Samples

Only natural health products listed below can be distributed as samples to adult consumers (18 years or older).

Column 1	Column 2	Column 3	Column 4	Column 5	Column 6
Class of Natural Health Products	Medicinal Ingredient (s)	Quantity of Medicinal Ingredient(s)	Qualifier (s)	Route(s) of Administration	Permissible Use(s) or Purpose(s)
Toothpastes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Mouthwashes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Antiseptic Skin Cleansers	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Sunscreens	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Anti-Dandruff Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Diaper Rash Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Medicated Skin Care Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics
Acne Therapy Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Throat Lozenges	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Athlete's Foot Treatments	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Antiperspirants	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes

Proposed list D: List of Certain Non-prescription Drugs for Distribution as Samples

Only non-prescription drugs listed below can be distributed as samples to adult consumers (18 years or older).

Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7
Class of Non-prescription Drugs	Medicinal Ingredient (s)	Quantity of Active Ingredient (s)	Qualifier (s)	Route(s) of Administration	Permissible Use(s) or Purpose(s)	Last Revised (YYYY-MM-DD)
Toothpastes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Mouthwashes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes	2020-03-13
Antiseptic Skin Cleansers	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Sunscreens	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Anti-Dandruff Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Diaper Rash Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Medicated Skin Care Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics	2020-03-13
Acne Therapy Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Throat Lozenges	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes	2020-03-13
Athlete's Foot Treatments	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Antiperspirants	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes

Proposed List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply

Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7
Class of Non-prescription Drugs	Active Ingredient (s)	Quantity of Active Ingredient (s)	Qualifier (s)	Route(s) of Administration	Permissible Use(s) or Purpose(s)	Last Revised (YYYY-MM-DD)
Toothpastes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Mouthwashes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes	2020-03-13
Antiseptic Skin Cleansers	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Sunscreens	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Anti-Dandruff Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Diaper Rash Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Medicated Skin Care Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics	2020-03-13
Acne Therapy Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Throat Lozenges	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes	2020-03-13
Athlete's Foot Treatments	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes	2020-03-13
Antiperspirants	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes