No Commercial Distribution or Test Marketing of an Investigational Drug

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

A sponsor or investigator may not commercially distribute or test market an investigational new drug prior to marketing approval.

Check

Review the communication or plan for content that indicates or promotes the commercial availability, sale, distribution, or test marketing of the investigational drug prior to approval (e.g., pricing for purchase, ordering/sales channels, launch or availability messaging suggesting the product can be obtained commercially). Treat such content as evidence of a possible violation of 312.7(b), to be assessed alongside context; the mere presence of cost or supply information (e.g., cost of goods, clinical-trial drug supply logistics) is not by itself dispositive under the text of 312.7(b).

Escalate when

Escalate to a human reviewer whenever the material references pricing, availability, ordering, supply, or distribution of the investigational drug and it is unclear from context whether this reflects commercial distribution/test marketing (prohibited) versus permissible clinical-trial logistics, cost-recovery, or scientific-exchange content.

Where this comes from

21 CFR 312.7(b). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution. (b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not commercially distribute or test market an investigational new drug. (c) Prolonging an investigation. A sponsor shall not unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application. [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19476, May 22, 1987; 67 FR 9585, Mar. 4, 2002; 74 FR 40899, Aug. 13, 2009] …

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 312.7
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: fda613253bfbb24458871266…

Applies when

Launch stagepre-approval

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Core statement is well supported: 21 CFR 312.7(b) is an unqualified prohibition ('shall not commercially distribute or test market an investigational new drug'), and 312.7(a)'s stated intent 'to preclude commercialization of the drug before it is approved for commercial distribution' supports the pre-approval framing.
- Authority 'binding' is correct (codified federal regulation); locator 21 CFR 312.7(b) is the correct subsection for the quoted language; 'blocker' severity is defensible for an absolute regulatory prohibition.
- applies_when (launch-stage: pre-approval) is justified by the source's subject matter (investigational new drugs) and is not an invented limit.
- Determinism is misflagged. Whether material evidences 'commercial' distribution is an interpretive judgment; the source gives no literal trigger terms, and the check's cues ('pricing, ordering, sales channels') are drafter-supplied proxies whose presence does not by itself settle the question.
- The check is broader than the source. 312.7(b) prohibits the act of commercially distributing or test marketing; the check flags any communication that merely describes or references such activity, and instructs 'Flag any such indication' for any mention of price or ordering. The provided text does not establish that every reference to cost or supply logistics constitutes prohibited commercial distribution.
- Rule is atomic (a single prohibited act), though it omits 'test market' from the quoted prohibition, leaving a coverage gap relative to its own quote.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is the complete operative text of 21 CFR 312.7(b), a freestanding mandatory prohibition ('shall not') — not an example, definition, or preamble summary. The rule statement is a near-verbatim restatement, so the requirement plainly follows from the source.
- The added qualifier 'prior to marketing approval' does not broaden the source: it is entailed by the term 'investigational new drug' and is corroborated by paragraph (a)'s stated intent 'to preclude commercialization of the drug before it is approved for commercial distribution.'
- Duty-holder scope is faithful. Paragraph (b) binds only 'a sponsor or investigator'; paragraph (a) additionally reaches 'any person acting on behalf of' them. The rule correctly does not import (a)'s broader class into (b).
- Not overstated. The check frames promotional/availability content as 'evidence of a possible violation ... to be assessed alongside context' and expressly states that cost-of-goods or clinical-trial supply information is not by itself dispositive. This correctly preserves the distinction between a conduct prohibition (distributing/test marketing) and document-level indicators, rather than converting any mention of price or supply into a per se breach.
- Atomic. 'Commercially distribute or test market' are two verbs expressing one prohibition on pre-approval commercialization; splitting them would yield two rules with an identical check and identical escalation trigger, so treating it as a single obligation is appropriate.
- Determinism 'judgment' is correct: nothing is settled by presence/absence or literal match. Whether ordering, pricing, or availability messaging constitutes commercial distribution or test marketing turns on characterization of conduct in context, and the escalation clause targets precisely that ambiguity — including the scientific-exchange carve-out preserved in paragraph (a).
- Authority 'binding' is correct; this is a codified federal regulation, not guidance.
- applies_when of launch-stage 'pre-approval' is justified by the text's limitation to an 'investigational new drug'; it neither invents a condition nor omits an obvious limit present in the source.
- Severity 'blocker' is defensible for an absolute regulatory 'shall not' whose violation constitutes unlawful pre-approval commercialization.
- Locator '21 CFR 312.7(b)' precisely identifies the paragraph quoted.

Nearby rules

US-PRE-004