The Centers for Disease Control and Prevention ("CDC") has reported 21 deaths caused by and 271 cases of fungal meningitis linked to compounded painkiller steroid injections as of October 19, 2012. The New England Compounding Center ("New England Compounding") located in Massachusetts shipped more than 17,000 vials containing contaminated steroid injections of preservative-free methylprednisolone acetate to 23 states resulting in approximately 14,000 patients receiving injections. Based on ongoing reports, it appears that New England Compounding was acting more like an unregulated drug company than a pharmacy preparing a drug product specifically for a single patient based on that doctor's prescription. "The red flag that they had overstepped was that they were producing 17,000 units of this steroid," said Marcus Ferrone, Associate Professor of Clinical Pharmacy at the University of California, San Francisco, who also directs the Drug Products Service Laboratory that compounds various drug products and has its own pharmacy course for students.
The current meningitis outbreak has led to a renewed scrutiny of the regulations for compounding pharmacies, pharmacies that specialize in taking existing drugs and formulating them, such as New England Compounding. Doctors and clinics often rely on compounding pharmacies to supply medications instead of major pharmaceutical companies, because often the drugs from compounding pharmacies are cheaper and in greater abundance. Much of the regulation of compounding pharmacies is performed not by FDA, but by state boards with varying standards.
FDA, wary of the potential danger of unregulated compounding pharmacies, developed guidelines for them culminating in the enactment of Section 503A of the Food and Drug Administration Modernization Act of 1997 ("FDAMA"). Section 503A exempted compounded drugs from the regulations instated by the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) for new drugs provided that they conform to a number of regulations, including that the compounded drug provider refrain from advertising the compounding of a specific drug. The U.S. Supreme Court found this to be a restriction on advertising and that Section 503A violated the First Amendment's free speech guarantee. Thompson v. Western State Medical Center, 535 U.S. 357, 360 (2002). Since the rest of Section 503A was found not be severable from the restriction on advertising by the court below and this finding was not challenged at the Supreme Court, the Supreme Court's decision invalidated the entire statute designed to regulate compounded drugs and compounding pharmacies. Id.
After Thompson v. Western State Medical Center, Congress did not specifically re-establish FDA's regulatory authority over compounding pharmacies. However, FDA may have retained some ability to regulate these pharmacies under the FD&C Act, which criminalizes introducing an unapproved drug into interstate commerce. FDA may be invoking this ability in its investigation of New England Compounding. Members of Congress have also been questioning FDA on their role in regulating New England Compounding. FDA maintains an updated archive addressing this issue here. According to FDA, FDA has dedicated many resources to this ongoing investigation of the outbreak, and it remains one of its top priorities to contain the health risk as quickly as possible.
Some tips being relayed by Cynthia Reilly, Director of the practice development division for the American Society of Health-System Pharmacists: (1) ask your doctor if your medication requires compounding, (2) ask your pharmacist whether it is familiar with your prescription and prepared it before, (3) check FDA's website for warning letters or other issues suggesting compliance issues, (4) avoid buying your drugs directly from your doctor, (5) be vigilant about the source of injectable, intravenous, eye medications, and dental products that may be compounded, and (6) consider postponing medical procedures involving compounding drugs until the outbreak has been contained.
