Articles  |   February 2016
ASA Participates in 2015 Pharmaceutical Compounding Roundtable
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Central and Peripheral Nervous Systems / Infectious Disease / Ophthalmologic Anesthesia / Pain Medicine / Pharmacology / Technology / Equipment / Monitoring / Advocacy and Legislative Issues / Articles
Articles   |   February 2016
ASA Participates in 2015 Pharmaceutical Compounding Roundtable
ASA Monitor 02 2016, Vol.80, 50-51.
ASA Monitor 02 2016, Vol.80, 50-51.
On October 8-9, the Pew Charitable Trusts and the American Society of Health-System Pharmacists (ASHP) brought together physician anesthesiologists, pain medicine experts, ophthalmologists and representatives from 503B outsourcing facilities (a new category of FDA-regulated drug compounders) for a roundtable discussion focused on compounded and repackaged drugs.
The Drug Quality and Security Act (DQSA) was signed into law following the 2012 multistate outbreak of fungal meningitis that originated from vials of contaminated preservative-free methylprednisolone acetate prepared at the New England Compounding Center in Framingham, Massachusetts. The act created a new category of compounders – 503B outsourcing facilities, which are subject to stricter standards than traditional state-regulated compounding facilities. The legislation mandated compliance with current good manufacturing practices (CGMPs), inspections by the FDA and a commitment to adhere to other conditions such as reporting adverse events.
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