In This Issue:
- Top News…1
- State News…5
- Regulatory News…8
- Additional Reading…8
- Federal Register…9
- For More Information…12
- Excerpt From Top News:
Congress, FDA Weigh Regulatory Changes to Compounding in Wake of Meningitis Outbreak
In response to the fungal meningitis outbreak linked to a New England pharmacy, Congress and the FDA are considering changes to the existing regulatory structure to reflect modern pharmacy practices. Twenty three deaths have been linked to a compounded batch of preservative free methylprednisolone acetate, a steroid injection. The FDA previously warned the pharmacy that provided the drug that its practices could be viewed as drug manufacturing and not compounding. The pharmacy, the New England Compounding Center, has since closed and recalled its products.
Pharmacies, including those that compound drugs, are generally regulated by the states. However, rather than compound one prescription at a time for individual patients, some pharmacies reportedly produced some products in bulk to have them ready for orders from hospitals and clinics, which could be considered manufacturing and subject to FDA oversight. In response to the growth in compounding and the regulatory uncertainty, the FDA is pushing for changes to what it described as a “patchwork” of existing regulations. FDA Deputy Commissioner Deb Autor said, “The world has changed a lot since the days of mortar and pestle, and this is the time for pharmacists, for lawmakers, for regulators and for doctors to sit down to grapple with this new model of pharmacy compounding and come up with a regulatory scheme that appropriately controls the risk.” Autor said that the regulations need to be clarified so it can be determined if a pharmacy has moved beyond compounding and into small scale drug manufacturing. She said there is a “legal dispute” over the FDA’s authority to examine pharmacy records. “It is the records that help us to determine whether a pharmacy is acting as a pharmacy or manufacturer,” she said.
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