Bill would make compounders register with FDA

The bill was spurred on by the recent deaths and infections caused by fungal contamination of drugs from a New England compounding pharmacy. Many are wondering if compounding pharmacies lack oversight that might have prevented contaminated product release. The bill, the Supporting Access to Formulated and Effective Compounded Drugs Act, seeks to have compounding pharmacies registered with the FDA, set minimum production standards, provide state regulators with training for oversight activities/policing.

Another bill was introduced earlier in November also in the interests of regulating compounding pharmacies more tightly. It is known as the Verifying Authority and Legality in Drug Compounding Act.

Read the full article.