After Meningitis Outbreak, Compounding Pharmacies Come Under the Regulatory Microscope
“… one law professor, Kevin Outterson of Boston University, told the New York Times: ‘The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts.’” (Patrick Malone)
Compounding pharmacies, where commercial drugs are altered for patients with specific needs (to remove allergens or transform pills into liquid medications, for example) play an important role in the delivery of health care.
But regulation of the pharmacies isn’t always clear. From law firm Mintz Levin:
“The FDA and individual state Boards of Pharmacy regulate compounding pharmacies, but the extent of each agency’s enforcement authority is unclear. The U.S. Drug Enforcement Agency also regulates compounding pharmacies when they handle controlled substances…
Although state Boards of Pharmacy generally license and survey all pharmacies, including compounding pharmacies, the state may or may not have separate, more rigorous, regulations or license requirements in place for compounding pharmacies.”
That’s all very likely to change. The recent outbreak of viral meningitis – 23 deaths and more than 300 infections that have been traced back to the New England Compounding Center – is expected to bring about increased federal and state regulation.
Three specific changes we can expect regarding oversight of compounding pharmacies:
1. A new regulatory regime:
“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.” (Polsinelli Shughart)
2. New rules for conducting business:
“… Congress and the FDA could define the activities compounding pharmacies must avoid to prevent being subject to regulation as a drug manufacturer more clearly.” (Mintz Levin)
3. Criminal charges when medications cause illness or death:
“The FDA’s Office of Criminal Investigations and members of the U.S. attorney’s office in Massachusetts searched the New England Compounding Center’s Framingham, Mass., facility Tuesday. Authorities have been tight-lipped about the nature of the investigation, and the warrant used to conduct the search remains under seal.” (Mintz Levin)
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The updates:
- Health Reform + Related Health Policy News - October 17, 2012 - Polsinelli Shughart PC
- Confounding Issues about Compounding Pharmacy Regulation - Mintz Levin
- Meningitis Suits Stand To Benefit From FDA Criminal Probe - Mintz Levin
- Your Money or Your Life: Injury Toll from Pain Injection Drugs Climbs - Patrick Malone & Associates P.C.
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Additional reading:
- Tainted Steroid Meningitis Outbreak – Are You at Risk? - Jodi Ginsberg
- Fungal Meningitis Linked to Tainted Steroid Kills 12, Sickens Over 100 - Schmidt & Clark, LLP
- Contaminated Drugs Affect the Whole Industry - Patrick Malone & Associates P.C.
- Drug Compounder Poisons Hundreds with Deadly Fungal Meningitis - Lawyers.com
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