House Bills Would Strengthen Federal Regulations for Compounding Pharmacies

Two bills have been introduced in the U.S. House of Representatives that would strengthen federal regulations of compounding pharmacies. The Verifying Authority and Legality in Drug (VALID) Compounding Act contains several provisions, including a measure to give the U.S. Food and Drug Administration (FDA) the authority to regulate pharmacies as drug manufacturers if the pharmacies are operating as drug manufacturers. The legislation would also require compounded drugs to be labeled as such to ensure that recipients know the drugs have not been tested for safety or effectiveness. The other bill, known as the Safe Compounding Drugs Act, would require compounding pharmacies to register with the FDA and would give the FDA the authority to set minimum production standards and impose new labeling restrictions on compounded drugs. These bills were introduced in response to the fungal meningitis outbreak that occurred as a result of tainted steroid injections from a compounding pharmacy in Massachusetts. For more information, go to http://www.aafp.org/news-now/news-in-brief/20121212wklynewsbrfs.html#NewsArticleParsys77801.

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The Law of Compounding Medications And Drugs

Tuesday, January 15, 2013