Research
The drug import route that is not for individuals
A federal regulation does authorize importing cheaper medicines from Canada. Reading who may apply, which drugs qualify and what testing is required shows why it has nothing to do with a parcel arriving at your door.
The program is real, and the applicant is a government
There is a genuine federal route for importing lower-priced prescription drugs from Canada. People hear about it and assume it means individuals may order from Canadian pharmacies. The regulation says who may apply in its first sentence.
The part sets out procedures that "Section 804 Importation Program sponsors (SIP Sponsors)" must follow when submitting plans to implement "time-limited programs to begin importation of drugs from Canada".
The sponsor is defined, and it is not a business. A sponsor means "a State or Indian Tribe that regulates wholesale drug distribution and the practice of pharmacy" that submits a proposal describing such a program.
A co-sponsor may be another state or tribe, or a pharmacist or wholesale distributor that signs the proposal alongside the sponsor.
The agency reviews the proposal, and only an authorized program may operate. Nothing in the structure contemplates a consumer applying.
The authorization is also short-lived by design. It "automatically terminates after 2 years", or sooner if the authorization says so, and the clock starts when the first import entry is filed.
It can lapse before it even runs. If no entry for a shipment is filed within a year of the stated date, the authorization terminates.
Which drugs qualify, and the list of what does not
The program only reaches an eligible prescription drug, which is a defined and narrow category.
The drug must have been approved by the Canadian health authority, with a notice of compliance and a Canadian identification number. It must also, apart from deviating from required United States labeling, meet the conditions in an approved United States application for a drug currently marketed here.
That approved application is compared on substance, not just name. The rule names the drug substance, drug product, production process, quality controls, equipment and facilities.
Then comes the exclusion list, and it is the part that decides most questions. It excludes "A controlled substance". It excludes "A biological product".
It excludes "An infused drug", including a peritoneal dialysis solution, and "An intravenously injected drug".
It excludes "A drug that is inhaled during surgery" and "An intrathecally or intraocularly injected drug".
It also excludes any drug subject to a risk evaluation and mitigation strategy, and any drug that is not a product for the purposes of the drug supply chain security law.
Read carefully, that list does not exclude every injection. Subcutaneous injection is not named in it. But the separate exclusion for biological products, and the one for drugs under a risk strategy, can each remove a particular medicine on their own. Whether a specific compound falls into either was not checked for this article.
The seller on the other end is licensed and constrained
The rule does not simply require a Canadian source. It defines the seller and rules out a familiar kind of business.
A foreign seller is "an establishment within Canada engaged in the distribution of an eligible prescription drug" that is imported or offered for import here.
It must hold an active Canadian wholesale drug establishment license, and be registered with provincial regulatory authorities to distribute drugs approved by that country.
And there is a prohibition attached. A foreign seller "must not be licensed by a provincial regulatory authority with an international pharmacy license" that lets it distribute drugs approved by countries other than Canada.
That single clause is the difference between this program and the international mail-order pharmacy model most consumers have encountered.
Foreign sellers also register with the agency, keep that registration current, and name an official contact and a United States agent.
The labeling problem, and how the rule solves it
A Canadian carton does not carry United States labeling, and the drug would be misbranded here without it. The rule handles that with a compelled license.
On request from a program sponsor or importer, the manufacturer must provide "written authorization for the Importer to use, at no cost, the FDA-approved labeling for the drug".
If the manufacturer does not do so within thirty calendar days of the request, "FDA may deem this authorization to have been given."
The importer then has to relabel with the full United States labeling set. The rule spells it out: container and carton labeling, prescribing information, and patient labeling such as medication guides, instructions for use and patient package inserts.
The importer also proposes a national drug code for each imported drug and lists it, following the ordinary registration and listing procedures. If it does the relabeling itself, it registers as a repackager or relabeler and obtains a labeler code.
So an imported product ends up carrying a United States code and a United States listing entry, which is what makes it traceable in the ordinary systems.
Every shipment gets tested, by a laboratory with a defined history
This is the requirement that most distinguishes the program from any consumer route.
The manufacturer or the importer must arrange for imported drugs to be tested by a qualifying laboratory.
A qualifying laboratory has three attributes. Accreditation to a named international testing standard. Compliance with the applicable manufacturing practice requirements, including the laboratory controls and laboratory records rules.
And a regulatory track record: it "must have an FDA inspection history", with any objectionable conditions or practices from its most recent inspection satisfactorily addressed.
The testing itself is specified. It runs on a statistically valid sample, and the sample "must be large enough to enable a statistically valid statement to be made regarding the authenticity and stability" of the batch or shipment.
It must confirm the Canadian drug meets the United States approved drug's specifications and standards, including analytical procedures, methods and acceptance criteria, and a stability-indicating assay must be run to test for degradation.
The manufacturer has to cooperate. Where it does not run the testing itself, it must supply the importer "within 30 calendar days of receiving the Importer's request". What it supplies is testing protocols, a certificate of analysis, analytical reference standards, formulation information and a stability-indicating assay.
What the importer is personally on the hook for
The importer's duties list reads like an inventory of the failure modes this market already has.
Examining the Canadian labeling of a sample from each shipment, to verify it is the labeling of the Canadian-approved drug, and attesting in reports that the examination happened.
Screening the drugs for evidence that they are adulterated, counterfeit, damaged, tampered with, expired, or suspect or illegitimate foreign product.
Arranging the customs entry, collecting and submitting the required information about the drugs and about the foreign seller, and submitting adverse event and field alert reports while complying with recalls.
The program also has its own supply chain security provisions and its own post-importation obligations, each with a full section.
None of these duties can be met by an individual buying for personal use, which is the practical reason the program does not translate into a consumer route.
What happens outside the program
The consequences section is short and it closes the loop.
An article imported or offered for import in violation of the underlying statutory section or this part "is subject to refusal under section 801" of the food and drug law.
Importing a prescription drug in violation of that section, falsifying any record required to be kept or provided under it, or any other violation of the part, is a prohibited act.
Authorized programs can also be ended. The agency may suspend or revoke an authorization, and a sponsor may seek modification or extension.
So the existence of a lawful Canadian import route does not create a general permission. It creates one narrow, supervised, time-limited channel with a state or similar sponsor at one end and a licensed Canadian wholesaler at the other.
Reading this against what a peptide buyer actually faces
For someone comparing an overseas offer against a domestic one, the useful conclusion is about what this program is not.
It is not a personal importation allowance. The separate agency discretion policy about personal shipments is a different instrument, and it is covered elsewhere on this site.
It is not a route for anything unapproved. Eligibility begins with a drug that is approved in both countries and currently marketed here, which excludes any compound that has no United States application at all.
And it is not a route that skips testing. Every shipment is sampled and tested against the United States approved product's own specifications by a laboratory with an inspection history.
Two limits belong here. Only part 251 was read. Whether any particular compound is a biological product, is subject to a risk strategy, or is currently marketed under an approved application was not checked. Nothing here says whether any specific medicine could ever qualify.
Key takeaways
- The program is applied for by sponsors, not individuals, and every duty in it sits with sponsors, importers and sellers.
- An authorization terminates automatically after two years, and lapses if no entry is filed within a year.
- Eligibility requires approval in both countries and current marketing in the United States.
- Controlled substances, biological products, infused, intravenous, intrathecal and intraocular drugs are excluded.
- Subcutaneous injection is not on the exclusion list, but other exclusions can still remove a medicine.
- The Canadian seller must not hold an international pharmacy license.
- A manufacturer must license its United States labeling free, or the authorization may be deemed given.
- Every shipment is sampled and tested by a laboratory with an inspection history.
Frequently asked questions
Does this rule let me buy my medicine from Canada?
No. A sponsor is defined as a State or Indian Tribe that regulates wholesale drug distribution and the practice of pharmacy. The part sets out procedures for those sponsors submitting plans for time-limited programs to import drugs from Canada, and requirements for the importers and foreign sellers involved. Every operational duty in it, from proposing a national drug code to arranging laboratory testing and filing customs entries, sits with those entities. There is no route in it for an individual buying for personal use.
Which drugs can be imported this way?
Only an eligible prescription drug. That means one approved by the Canadian health authority, with a notice of compliance and a Canadian identification number. Apart from labeling, it must also meet the conditions of a United States approved application for a drug currently marketed here. The definition then excludes controlled substances and biological products. It also excludes infused drugs, intravenously injected drugs, drugs inhaled during surgery, and intrathecally or intraocularly injected drugs. Two further exclusions cover drugs under a risk evaluation and mitigation strategy, and drugs that are not a product for supply chain security purposes.
Are injectable medicines excluded?
Some routes are named and some are not. The list excludes infused drugs, intravenously injected drugs, and intrathecally or intraocularly injected drugs. Subcutaneous injection is not on that list. However, the separate exclusions for biological products and for drugs under a risk evaluation and mitigation strategy can each remove a medicine on their own. Whether any particular compound falls into either was not checked here.
Who can be the Canadian seller?
An establishment within Canada engaged in distributing an eligible prescription drug, holding an active Canadian wholesale drug establishment license and registered with provincial regulatory authorities to distribute Canadian-approved drugs. It must not hold a provincial international pharmacy license allowing it to distribute drugs approved by countries other than Canada. It also registers with the agency and names an official contact and a United States agent.
How does an imported drug get United States labeling?
The manufacturer must, on request, give the importer written authorization to use the United States approved labeling at no cost. If it fails to do so within thirty calendar days, the agency may deem the authorization given. The importer then relabels with the full set, including container and carton labeling, prescribing information and patient labeling, and proposes a national drug code and lists the drug.
Is imported product tested?
Every batch or shipment. Testing is done by a qualifying laboratory. That laboratory must hold accreditation to a named international testing standard, comply with the applicable manufacturing practice requirements including laboratory controls and records, and have an inspection history with any objectionable findings satisfactorily addressed. The sample must be large enough for a statistically valid statement about authenticity and stability, and a stability-indicating assay must be run to test for degradation.
What happens if someone imports outside the program?
The article is subject to refusal at the border under the general import provision. Importing a prescription drug in violation of the underlying statutory section, falsifying any record required under it, or any other violation of the part is a prohibited act. Authorized programs themselves can also be suspended or revoked, and every authorization terminates automatically after two years unless extended.
Sources
Each document below is named as it names itself, with the date printed on that document rather than the day it was read.
- Title 21 Code of Federal Regulations section 251.1, Scope of the part, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.2, Definitions, read for the eligible prescription drug definition and its eight exclusions, and for the Foreign Seller definition — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.6, Termination of authorized importation programs, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.12, Importer responsibilities, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.13, Labeling of eligible prescription drugs, read for the compelled labeling authorization and the thirty-day deeming provision — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.15, Qualifying laboratory requirements, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.16, Laboratory testing requirements, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020
- Title 21 Code of Federal Regulations section 251.21, Consequences for violations, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, October 2020