The US Food and Drug Administration (FDA) has announced the formation of an eagerly awaited advisory committee set to offer critical input in deciding which drug products will no longer be allowed to be compounded under the terms of a recent piece of legislation.
Unlike more traditional pharmaceutical manufacturers—think Pfizer, for example—compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.
But as a massive outbreak of fungal meningitis in late 2012 illustrated, not all was well in the compounding sector. FDA investigators would later determine that deficient quality practices at a compounding pharmacy had resulted in patients being exposed to contaminated products, and a subsequent surge of inspections found dozens of compounders with similar deficiencies.
Those findings in hand, legislators passed the DQSA, which creates a new system in which some compounding pharmacies will register with FDA and consent to inspections. The hope, legislators said, is that this category of pharmacy will be sought after by consumers because of the quality assurances they offer relative to smaller pharmacies.
So which drugs will be on that list? While the final determination will be up to FDA, it's due to receive help from an Advisory Committee created in 2012 and, as of 10 January 2014, seeking new members.
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Background
That legislation, the Drug Quality and Security Act (DQSA), was passed into law on 27 November 2013, and contained numerous provisions intended to regulate pharmaceutical products produced by so-called "compounding pharmacies."Unlike more traditional pharmaceutical manufacturers—think Pfizer, for example—compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.
But as a massive outbreak of fungal meningitis in late 2012 illustrated, not all was well in the compounding sector. FDA investigators would later determine that deficient quality practices at a compounding pharmacy had resulted in patients being exposed to contaminated products, and a subsequent surge of inspections found dozens of compounders with similar deficiencies.
Those findings in hand, legislators passed the DQSA, which creates a new system in which some compounding pharmacies will register with FDA and consent to inspections. The hope, legislators said, is that this category of pharmacy will be sought after by consumers because of the quality assurances they offer relative to smaller pharmacies.
The Pharmacy Compounding Advisory Committee
But unlike their state-regulated counterparts, federally regulated "outsourcing pharmacies" will be subject to additional restrictions. Chief among those restrictions: not compounding any drug product present on a "difficult-to-compound" list. The theory is that certain drugs present unique challenges that make it difficult for companies to assure their potency, quality, consistency and bioavailability. Rather than risk patient safety, FDA will require those drugs to only be made by approved manufacturers.So which drugs will be on that list? While the final determination will be up to FDA, it's due to receive help from an Advisory Committee created in 2012 and, as of 10 January 2014, seeking new members.
continue to read here