FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bulks for patient use.
Generally, API repackers take bulk API (usually in powder form) from the container in which it was distributed by the original manufacturer and place it into a different container without further manipulation of the drug and distribute it to drug manufacturers, compounding pharmacies or outsourcing facilities. Improper repackaging or lack of supply chain oversight of API can cause serious vulnerabilities in the supply chain and may lead to patient safety issues.
The agency has issued alerts about safety issues with repackaged porcine thyroid API and baclofen API, as well as highlighted concerns with using dietary ingredient glutathione to compound sterile injectables. There also have been other recalls related to bulk API, including Darmerica LLC , which shipped API labeled as quinacrine dihydrochloride (HCI) to compounding pharmacies nationwide. Tests later identified the API as artemisinin.
FDA remains vigilant in our inspections and oversight of the supply chain. As part of this effort, we inspect API repackers to help identify and prevent any weaknesses in the legitimate supply chain. For patient safety and supply chain transparency, repackers must follow all quality standards pertaining to them, including clearly identifying the original API manufacturer to their customers who use them to make the finished drugs patients take every day.
FDA also has issued warning letters to API repackers for significant violations of current good manufacturing practice (CGMP) requirements, including:
- Yino Inc., August 12, 2019
- Asclemed USA Inc., doing business as Enovachem, July 7, 2019
- B&B Pharmaceuticals Inc., June 4, 2019
- Spectrum Laboratory Products Inc., June 4, 2019
- Sal Pharma, April 20, 2019
- Huron Pharmaceuticals, Inc., April 20, 2019
- Lumis Global Pharmaceuticals Co. Ltd., March 2, 2019
- Vipor Chemicals Private Ltd., January 29, 2019
- Fagron Inc., August 29, 2018
- Sichuan Friendly Pharmaceutical Co. Limited, June 22, 2018
Additionally, the agency has placed API repackers, including Lumis Global Pharmaceuticals Co. Ltd. and Sal Pharma, on import alert to keep their API from ultimately reaching U.S. patients because they failed to meet CGMP requirements.
Resources for You
- See Guidance for Industry: ICHQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for more information on how API, from original manufacturers as well as API repackers and relabelers, should be labeled and clearly identify the original API manufacturer as the API moves through the supply chain.