Something Old, Something New, Something Borrowed And Something Missing

Since 2002, the law governing pharmacy compounding (21 USC 353a) has suffered a crippling constitutional defect. It took a significant human tragedy to draw the attention of Congress, and on September 27, 2013, the House and Senate announced agreement on the Drug Quality and Security Act. Under Title I the "Compounding Quality Act" seeks to amend the Food Drug and Cosmetic Act ("FDCA") by inserting a new section, 21 USC 353b. According to House Member Waxman "[t]he bill will correct the constitutional defect in the FDA's drug compounding statute that has wreaked havoc on the Agency's ability to effectively enforce the law for years." (See here).

The "constitutional defect" relates to the "advertising and promotion" provisions having been declared unconstitutional in Thompson v. Western States, 535 US 357 (2002). Confusion concerning the status of the law was compounded because the Supreme Court did not rule on whether the unconstitutional provision was severable. In the Ninth Circuit, the entire Pharmacy Compounding provision had been stricken, but 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 Food Drug and Cosmetic Act (FDCA") and is as old as the practice of medicine itself. In 2012, Massachusetts based New England Compounding Center ("NECC") was 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 following up on the warning signals that had been plainly obvious and 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, a sanctimonious Congress raked an evasive and nonresponsive Food and Drug Administration ("FDA") Commissioner Hamburg over the coals for failing to coherently 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).

In its July 31, 2013 report to Congress, the Government Accountability Office recommended that Congress close the "gap" in FDA oversight caused by "compounding in large...