Raw material expiration dating 21cfr


02-Oct-2018 08:03

Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.

of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data.

(1) Import permit number; (2) Date shipment arrived at the United States port of entry; (3) Actual quantity shipped; (4) Assay (percent) of morphine, codeine and thebaine and (5) Quantity shipped, expressed as anhydrous morphine alkaloid. Where final assay data is not determined at the time of rendering report, the report shall be made on the basis of the best data available, subject to adjustment, and the necessary adjusting entries shall be made on the next report.

More limitations on accuracy are described at the GPO site. The following are only the Rules published in the Federal Register after the published date of Title 21.

Final printed labeling will ordinarily be required prior to approval of an application.

Proposed advertising for veterinary prescription drugs may be submitted for comment or approval.

To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166.

New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations.

Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission.



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