FDA Issues Guidance on Identifying Suspect Drugs - - BioPharm International

ADVERTISEMENT

FDA Issues Guidance on Identifying Suspect Drugs


FDA has issued a draft guidance document on how to identify suspect drug products in the supply chain. The draft guidance, developed under the Drug Supply Chain Security Act, describes potential signs that drug supply-chain stakeholders can look for to identify suspect drugs, including product labeling that may contain misspelled words or looks different than the standard labeling; packaging that has missing lot numbers or expiration dates or has been opened, damaged, or altered; or a change in shape or color from the standard product.

Supply-chain stakeholders are encouraged by FDA to be cautious when purchasing drugs from a new or unknown source, from the Internet, or purchasing drugs on the drug shortage list. Unsolicited offers for lower-priced drugs should also be avoided. The draft guidance provides supply-chain stakeholders with information on how to notify FDA of illegitimate products and details a process for stakeholders to follow when terminating previously made notifications.

FDA is requesting that comments on the draft be submitted by Aug. 11, 2014 for consideration as the agency works on the final version of the guidance.

Source: FDA.gov

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines

Click here