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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter CPart 203Subpart D → §203.32


Title 21: Food and Drugs
PART 203—PRESCRIPTION DRUG MARKETING
Subpart D—Samples


§203.32   Drug sample storage and handling requirements.

(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.

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