What a Drug Sample Is, and Why It Cannot Be Sold

Answer first: the definition is about intent, and the ban is flat

The statute defines the term in a single clause. Under 21 U.S.C. 353(c)(1), a drug sample means "a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug." The regulation implementing it uses almost identical words: a drug sample "means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug."

Subsection (b) is the prescription-drug provision, so a sample in this sense is always a unit of a prescription drug. The two intent clauses are what separate a sample from ordinary stock: it is not meant to be sold, and it exists to promote sales.

The prohibition attached to that definition has no qualifiers. The same paragraph opens: "No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample." Not the manufacturer, not a distributor, not a pharmacy, not a prescriber, not a patient. The regulation's own purpose statement explains the reason: the part exists "to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and prescription drug samples."

Who may receive one, and the paperwork that has to exist first

Samples do not move freely even when nobody is selling them. For distribution by mail or common carrier, the regulation permits a manufacturer or authorized distributor of record to send a sample to a practitioner licensed to prescribe the drug being sampled, or — at that practitioner's written request — to the pharmacy of a hospital or other health care entity, and only if four conditions are met.

The practitioner must execute and submit a written request before delivery. The manufacturer or distributor must verify "with the appropriate State authority that the practitioner requesting the drug sample is licensed or authorized under State law to prescribe the drug product." The recipient must execute a written receipt when the sample is delivered. And that receipt must be returned to the manufacturer or distributor it came from.

So the ordinary path for a sample runs to a licensed prescriber, on a signed request, with a signed receipt going back. The statutory definition of "distribute" in the regulation carves out one downstream step: it does not include "providing of a drug sample to a patient by" a practitioner licensed to prescribe the drug, a health care professional acting at that practitioner's direction and supervision, or the pharmacy of a hospital or other health care entity acting at the practitioner's direction that received the sample lawfully.

That carve-out is the whole of the lawful route from a sample to a patient, and every branch of it runs through a licensed practitioner.

The label has to say what it is, and the lot number has to lead back

The regulation requires the sample unit to announce itself. "Each sample unit shall bear a label that clearly denotes its status as a drug sample, e.g., 'sample,' 'not for sale,' 'professional courtesy package.'"

It then closes the obvious loophole in both directions. A drug labeled as a drug sample "is deemed to be a drug sample within the meaning of the act," and so is a dosage unit bearing an imprint identifying it as one. And notwithstanding both of those, "any article that is a drug sample as defined in section 503(c)(1) of the act and § 203.3(i) that fails to bear the label required in this paragraph (c) is a drug sample." Removing the word sample does not change what the unit is.

Traceability is required as well. The manufacturer or authorized distributor must put an identifying lot or control number on the label of the sample unit and on the outside container or packaging, "that will permit the tracking of the distribution of each drug sample unit," and must keep distribution records containing those numbers "sufficient to permit the tracking of sample units to the point of the licensed practitioner."

Storage is not left to convenience either. Manufacturers, authorized distributors and their representatives "shall store and handle all drug samples under conditions that will maintain their stability, integrity, and effectiveness and ensure that the drug samples are free of contamination, deterioration, and adulteration."

Losses and diversion carry a clock

The part attaches reporting duties to the two things most likely to precede a sample turning up somewhere it should not be. A manufacturer or authorized distributor of record that "has reason to believe that any person has falsified drug sample requests, receipts, or records, or is diverting drug samples" must notify FDA by telephone or in writing within 5 working days, immediately begin an investigation, and provide a complete written report including the reason for and results of the investigation not later than 30 days after the initial notification.

The same clock applies to a significant loss or known theft of drug samples: notification within 5 working days of becoming aware of it, an immediate investigation, and a complete written report within 30 days. That duty also reaches a charitable institution receiving donated samples from a licensed practitioner.

There is a third notification, and it is unusual enough to be worth quoting the shape of. A manufacturer or authorized distributor must notify FDA within 30 days of learning of "the conviction of one or more of its representatives for a violation of section 503(c)(1) of the act or any State law involving the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample," with a complete written report to follow within another 30 days.

Two more restrictions people meet without knowing the name of the rule

The same part restricts the resale of drugs that were bought cheaply by institutions. Section 203.20 states that, with stated exceptions, "no person may sell, purchase, or trade, or offer to sell, purchase, or trade any prescription drug that was" purchased by a public or private hospital or other health care entity, or donated or supplied at a reduced price to a charitable organization. The statute carries the same rule at 21 U.S.C. 353(c)(3).

The exceptions are specific rather than general: purchases within a group purchasing organization, transfers to a nonprofit affiliate, transfers among entities under common control, transfers "for emergency medical reasons," and — the one most people are actually inside — "the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug under a valid prescription." Emergency medical reasons is itself defined in the regulation and expressly excludes "regular and systematic sales to licensed practitioners of prescription drugs that will be used for routine office procedures."

Penalties sit in a different section. Under 21 U.S.C. 333(b)(1)(B), a person who knowingly sells, purchases or trades a drug or drug sample, or knowingly offers to, in violation of section 353(c)(1) "shall be imprisoned for not more than 10 years or fined not more than $250,000, or both." For comparison, the general penalty for violating the act's prohibited acts in section 333(a)(1) is imprisonment of not more than one year or a fine of not more than $1,000. Congress wrote this one an order of magnitude heavier.

There are also civil penalties aimed at employers. Where a representative of a manufacturer or distributor that distributes samples other than by mail or common carrier is convicted of a sample violation, the company faces a civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction in any 10-year period, and not more than $1,000,000 for each violation resulting in a conviction after the second in that period.

What this changes about reading an offer

The everyday use of the word sample is looser than the legal one. A promotional discount, a first-month price, a trial subscription and a bonus item are commercial arrangements; whether any of them is a drug sample under this definition turns on the two intent clauses, and this site is not in a position to say what any particular seller intends.

What the rules do establish is that a genuine drug sample is not a thing anyone may buy. If a unit of a prescription drug is a sample, no price is a lawful price for it, and that is true whether or not the word sample still appears on the carton, because the regulation says a sample that fails to bear the required label is still a sample.

The practical questions are narrow and answerable. Is the thing being offered a unit of a prescription drug or something else. Does the carton carry a status statement such as sample or not for sale. And is money changing hands for that unit specifically. A reader who wants an authoritative answer about a particular product should ask the pharmacy that dispensed it or the state board that licenses it, and this site takes no position on any individual case.