No Test Marketing of an Investigational Drug

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

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

Check

Check whether the material describes, announces, or supports market-testing activity (market test, pilot market, pricing trial, trial sales) for a drug that has not received marketing approval. Flag any such indication.

Escalate when

The activity described is ambiguous as to whether it constitutes 'test marketing' (e.g., limited pricing pilots, regional sampling programs, or market research that may or may not amount to testing the market for the drug) versus permissible scientific exchange or internal market research not directed at the drug's commercial viability.

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
- Supported: 21 CFR 312.7(b) is operative regulatory text stating flatly that 'A sponsor or investigator shall not commercially distribute or test market an investigational new drug.' The rule statement restates the test-marketing half verbatim in substance; it is not drawn from an example, definition, or preamble.
- Not overstated: the source uses mandatory 'shall not', so phrasing as a prohibition is correct. The added qualifier 'prior to marketing approval' is inherent in the term 'investigational new drug' and is reinforced by (a)'s stated intent 'to preclude commercialization of the drug before it is approved for commercial distribution.'
- Atomic: the rule isolates the test-marketing prong and leaves the separate commercial-distribution prong of (b) to another rule. However, the Check reintroduces 'limited-market commercial rollout,' which drifts into the commercial-distribution prong the rule statement deliberately excludes; the check should stay scoped to test marketing.
- Determinism is wrong: nothing here is settled by presence/absence or a literal string. Deciding whether a described activity (a regional launch, a pricing pilot, a limited rollout) constitutes 'test marketing' of an investigational product is an interpretive call about the nature of the activity, so this is 'judgment'.
- Authority correct: 21 CFR is a regulation, so 'binding' is right.
- applies_when (launch-stage: pre-approval) is justified — the prohibition attaches only while the drug is investigational and unapproved, and the limit is neither invented nor over-broad.
- Severity 'blocker' is defensible: violating an express regulatory prohibition under Part 312 carries enforcement exposure and cannot be cured by softening language.
- Locator '21 CFR 312.7(b)' is accurate; the quoted sentence is exactly paragraph (b).
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 entire operative text of 21 CFR 312.7(b), a standalone regulatory prohibition - not an example, definition, preamble summary, or description of what the rule does not require. The rule statement is a direct restatement of it.
- No overstatement: the source uses mandatory 'shall not', which the rule renders as 'may not'. The qualifier 'prior to marketing approval' is supported by the investigational status trigger and by 312.7(a)'s stated intent 'to preclude commercialization of the drug before it is approved for commercial distribution'.
- Atomic: the source sentence contains two prohibitions (commercial distribution and test marketing); the rule correctly isolates only test marketing rather than bundling both into one check.
- Determinism 'judgment' is correct - 'test market' is undefined in the source, and classifying a pricing pilot, regional sampling program, or market research effort as test marketing turns on interpretation rather than a literal match. The escalate clause accurately targets this boundary.
- Authority 'binding' is correct - this is codified regulation in the CFR, not guidance.
- The check does not encroach on the scientific-exchange carve-out preserved in 312.7(a); the escalate clause explicitly distinguishes permissible scientific exchange and internal market research.
- Locator 21 CFR 312.7(b) is precise - the quote is exactly the text of subsection (b). Severity 'blocker' is defensible for an express regulatory prohibition. The pre-approval applies_when is justified by the 'investigational new drug' trigger; it is marginally under-inclusive for drugs approved in one indication but investigational in another, which narrows rather than overstates the rule and is not grounds to withhold a pass.

Nearby rules

US-PRE-003