FDA Drafts Compounding Pharmacy Safety Regulations

July 1, 2014 — As part of enhanced regulation of the compounding pharmacy industry, the U.S. Food and Drug Administration (FDA) has issued documents describing manufacturing expectations, enforcement policies for safety violations, and proposed revisions to a list of drugs that may not be compounded.

The documents include:

• Draft guidance (PDF) for manufacturing practices related to sterility assurance of drug products and the general safety of compounded drugs.
• Proposed rule that would add 25 drugs to a list of products that cannot be compounded.
• Final guidance contains a non-exhaustive list of potential enforcement actions against individuals or pharmacies that violate rules.

The FDA also re-opening the nomination process for new pharmaceutical substances that can be used to compound drugs.

Meanwhile, CBS News reports that Massachusetts lawmakers have approved a bill reorganizing the state’s pharmacy board, creating four speciality licenses, and authorizing hefty fines for safety violations — up to $25,000 per violation and $1,000 for each day that a violation occurs.

Massachusetts was once home to New England Compounding Center (NECC), a compounding pharmacy that distributed thousands of vials of medicine that infected over 700 people with fungal meningitis. The outbreak caused 64 deaths in 20 states.

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