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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.196]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart J – Records and Reports
Sec. 211.196 Distribution records.
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
Link to an amendment published at 89 FR 51770, June 18, 2024.
[49 FR 9865, Mar. 16, 1984]
As per US Health & Human Services, the information on this page is current as of Aug. 30 2024.
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