Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Anti-Bacterial Agents beta-Lactams Drug Compounding Government Regulation Legislation, Drug United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance describes the Food and Drug Administration’s (FDA or the Agency) regulatory and enforcement priorities regarding preparation of beta-lactam oral antibiotic suspension products that appear on FDA’s drug shortage list by a licensed pharmacist in a State-licensed pharmacy or Federal facility. There is currently an acute shortage of amoxicillin oral antibiotic powder for suspension. Amoxicillin oral antibiotic powder for suspension products currently appear on FDA’s drug shortage list. Amoxicillin is widely used for the treatment of bacterial upper and lower respiratory infections in the pediatric population, among other uses. As a result of this shortage, there is an urgent need to increase the supply of these beta-lactam oral suspension products. FDA has received a number of reports related to increased demand for amoxicillin oral antibiotic suspension products in particular. FDA has also received requests for clarification about preparation of compounded versions of those products from FDA-approved tablets and capsules.
- 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, 5 pages))
- NLM Unique ID:
- 9918590085806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918590085806676