The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance

Content:
This guidance states the circumstances under which the Food and Drug Administration (FDA) intends to exercise its enforcement discretion and does not intend to take enforcement action against such repackagers for failure to conduct stability studies to support expiration dates for these unit-dose repackaged products.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK