JenniferStaman
Legislative Attorney
Inlight of the recent meningitis outbreak, believed to have been caused by acontaminated compounded steroid injection, the regulation of drugcompounding has received significant attention. Compounding istraditionally defined as a process of combining, mixing, or altering ingredientsin order to create a medication for a particular patient. However, as in thecase of the pharmacy that produced the steroid medication, concerns havebeen raised about compounding pharmacies producing drugs on a largerscale, something more akin to drug manufacturing. While drug compoundinghas historically been regulated primarily by states through their regulation of pharmacies,recent questions have been raised about the extent to which the Federal Food,Drug, and Cosmetic Act (FFDCA) governs this practice, and what authoritythe U.S. Food and Drug Administration (FDA) has to regulate a compoundeddrug as a “new drug,” subject to approval by the FDA, as well as otherrequirements.
In 1997, Congress enacted the FDA Modernization Act of 1997 (FDAMA), which wasa comprehensive revision of the FFDCA. Section 127 of FDAMA added Section503A to the FFDCA, which excepted compounded drugs from various “new drug”requirements, conditioned upon the compounded drugs meeting a variety ofrestrictions. One of the restrictions in Section 503A of the FFDCA wasthat drug providers were prohibited from soliciting or advertising particularcompounded drugs. These speech restrictions were challenged on First Amendment groundsand were struck down by the Supreme Court in Thompson v. Western StatesMedical Center. Following this decision, there was controversy overthe current status of compounded drugs under the FFDCA and whether theremaining provisions of Section 503A remain good law, an issue that theSupreme Court did not address in Western States. The two circuits thataddressed this issue took different positions. While the Ninth Circuit in WesternStates determined that Section 503A was struck down in its entirety,the Fifth Circuit in Medical Center Pharmacy v. Mukasey found thatthe lawful provisions of Section 503A are still in effect. Accordingly, these caseshave created an interesting scenario of non-uniform enforcement throughout theU.S. In the Fifth Circuit, compounded drugs are specifically exempted fromnew-drug, adulteration, and misbranding requirements of the FFDCA ifcertain criteria are met; while in the Ninth Circuit (and, according tothe FDA, the rest of the United States), compounded drugs are subject to these requirements,but the FDA may exercise discretion in taking action against an entity thatviolates these provisions. This report provides a brief historicaloverview of the FDA’s regulation of drug compounding and addresses theseconflicting decisions. The report will also address the FDA’s currentauthority to regulate compounded drugs under the FFDCA in light of thesedecisions.
Date of Report: October 17, 2012
Number of Pages: 14
Order Number: R40503
Price: $29.95
To Order:
R40503.pdf to use the SECURE SHOPPING CART
e-mail congress@pennyhill.com
Phone301-253-0881For email and phone orders, provide a Visa, MasterCard, American Express, or Discover cardnumber, expiration date, and name on the card. Indicate whether you want e-mailor postal delivery. Phone orders are preferred and receive priority processing.
Hiç yorum yok:
Yorum Gönder