C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 203—PRESCRIPTION DRUG MARKETING › Subpart D—Samples

21 C.F.R. § 203.32

Drug sample storage and handling requirements

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(a) Storage and handling conditions. Manufacturers, authorized distributors of record, 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.

(b) Compliance with compendial and labeling requirements. Manufacturers, authorized distributors of record, and their representatives can generally comply with this section by following the compendial and labeling requirements for storage and handling of a particular prescription drug in handling samples of that drug.

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2023–2023 · leading case: Ellis v. Cvs Health Corp. (E.D. Pa. 2023).
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Ellis v. Cvs Health Corp. (E.D. Pa. 2023). “Finally, Plaintiff quotes language from 21 C.F.R. § 203.32 and § 203.36, but those are likewise not cGMP regulations, and they apply only to drug samples not intended for sale.”
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