C.F.R. » Title 21 » 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 H—Holding and Distribution

21 C.F.R. § 211.150

Distribution procedures

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:

(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.

(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

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).
Sort: Relevance Newest Treatment
Ellis v. Cvs Health Corp. (E.D. Pa. 2023). “The neighboring provision, 21 C.F.R. § 211.150 , which focuses on distribution, does not mandate that pharmaceuticals stay within a certain temperature range or avoid flash freezing.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.