Expiration dating of unit-dose repackaged solid oral dosage form drug products
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Administration, Oral Drug Labeling -- standards Drug Packaging -- standards Time Factors United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances. This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to comply with current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 4 pages)).
- NLM Unique ID:
- 9918227979506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227979506676