The Pharmacy Compounding Quality Act Of 2013: Something Old, Something New, Something Borrowed And Something Missing

Since 2002, the law governing pharmacy compounding (21 USC 353a) has suffered from a crippling constitutional defect. After a significant human tragedy which drew the attention of Congress, the Senate sent the Drug Quality and Security Act to the President for signature on November 18, 2013. Under Title I, the Compounding Quality Act (the Act) amends the Food Drug and Cosmetic Act ("FDCA") by inserting a new section, 21 USC 353b. According to Senator Michael Bennet, "[t]he legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide." ( See here).

The "unconstitutional provisions" relates to the "advertising and promotion" provisions that were declared unconstitutional in Thompson v. Western States, 535 US 357 (2002). The Supreme Court created further confusion when it failed to rule on whether the unconstitutional provision was severable from the rest of the law. In Thompson v. Western States, the Ninth Circuit struck the entire Pharmacy Compounding provision while the Fifth Circuit took a different view in Medical Center Pharmacy v. Mukasey, 536 F.3d 383 (5th Cir. 2008), ruling the advertising prohibitions were severable.

Why Now?

Pharmacy compounding of medications predates the FDCA and is as old as the practice of medicine itself. In 2012, Massachusetts based New England Compounding Center ("NECC") found itself at the center of a meningitis outbreak linked to contaminated sterile injections that were ultimately linked to multiple deaths. Even though the federal law had been in a state of disarray for more than a decade, the NECC disaster could have been avoided by simply investigating the obvious warning signals for which the State of Massachusetts and the FDA had ample authority and power.

On November 15, 2012, after hearing emotional testimony from the family of a patient who had been exposed to a NECC product, Congress questioned Food and Drug Administration ("FDA") Commissioner Hamburg for failing to explain the FDA's authority to regulate and oversee the practice of compounding pharmacy generally and for failing to follow up on its 2002 warnings to NECC. (See here). On July 31, 2013, the Government Accountability Office recommended that Congress close the "gap" in FDA oversight caused by "compounding in large drugs quantities - in anticipation of individual prescriptions or without prescriptions where the drugs are sold across state...