Should New Federal Legislation Similar to the Safe Drug Compound Act of 2007 Giving the FDA Authority to Regulate Compounding Be Enacted in Light of the New England Compounding Center Meningitis Outbreak

The Safe Drug Compounding Act of 2007 was drafted as a Senate bill.  Its purpose was to redefine oversight and regulation of the practice of pharmacy compounding by giving power to the FDA to inspect all retail pharmacies that made or dispensed compounded medications and to determine whether or not compounded medications were medically necessary or  "essentially copies" of existing FDA-approved medications. The draft bill also would have taken a number of steps to inhibit the distribution of compounded medications beyond state lines by requiring compounding pharmacies to provide detailed documentation on all intrastate orders and asking state pharmacy boards to "discourage the distribution of inordinate amounts of compound drug products in interstate commerce."  The bill never passed.

Pharmacists and pharmacy organizations opposed the draft bill, expressing concern that the Safe Drug Compounding Act of 2007, would restrain the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations--the American Pharmacists Association, National Community Pharmacists Association, International Academy of Compounding Pharmacists (IACP), American College of Apothecaries, American  Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, Massachusetts Pharmacists Association, North Carolina Association of Pharmacists, and Kansas Pharmacists Association --  drafted a letter to the bill's expected sponsors. insisting that the draft legislation "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists" and urging that this draft legislation not be introduced.  The coalition of none pointed out the work of the U.S. Pharmacopeia, state boards of pharmacy, and the Pharmacy Compounding Accreditation Board (PCAB) and promised to work with Congress to address concerns about compounding.

Compounding critics, however, wanted the draft bill to pass, insisted that the act would clarify several issues that have been unclear since 1997 when the Supreme Court struck down portions of the FDA Modernization Act (FDAMA) dealing with compounding, and  claimed it would help correct the problems and dangers associated with pharmacy compounding.  The 2007  legislation was sponsored by Senator Ted Kennedy and co-sponsored by Senators Pat Roberts and Richard Burr.  The bill previously failed to become law.  Senator Richard Blumenthal (D-Conn.) called for stronger federal oversight of compounding pharmacies.  In a letter to the FDA, Senator Blumenthal states:

 “This tragic incident calls for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies. I remain particularly concerned that compounding, which is intended for individual patient special needs, may have grown more broadly in some instances, into widespread and multi-state distribution."

To read the entire letter click here.  Is federal legislation already in the works?  What should the federal legislation cover?  What should it not cover?  How board should it be?

Phederalism: The Turf War Between Pharmacies and the FDA Over Who Has Jurisdiction When It Comes to Compounded Drugs

Although an older article,Roger A. Fairfax, "Phederalism": The Regulation of Pharmacy Compounding and Two Years in the Regulatory Turf War Between Pharmacy and the Food and Drug Administration, Harvard (Winter Term 1998), does a great job of examining the history of the turf war between pharmacies and the FDA when it comes to compounded drugs through 1998.  The paper can be read here.

Criminal Charges in a Compounding Case: Exercise of Federal Authority

The Criminal Information filed against ApothéCure, a major compounder in the United States, and Gary D. Osborn charges violations of 21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors.  Basically, the information charges that  ApothéCure and Gary D. Osborn introduced in interstate commerce a misbranded drug in that its label was false and misleading.  Criminal misdemeanors under the federal system are criminal offenses eligible for terms of imprisonment that do not exceed one year but are more than six months in length by federal statute. See 18 U.S.C. 3559(a)(6)  Under the federal system, the district court also uses the advisory United States Sentencing Guidelines to determine the range and actual punishment.  Both the criminal charges in ApothéCure and the attempt to obtain an injunction in Franck's show the FDA and DOJ attempting to exercise its federal jurisdiction to regulate and punish compounders who step out of bounds.  It will be interesting to see how far the federal courts allow the FDA and DOJ  to exercise this power against other compounders who violate the law.   The appeal  in Franck's while only binding on those states in the 11th Circuit Court of Appeals--Alabama, Florida, and Georgia--will be precedent setting with the possibility, no matter the outcome, of making its way to the United States Supreme Court.  The other possibility if DOJ/FDA loses the appeal is for there to be a legislative fix attempting to define the parameters of federal jurisdiction to regulate this area of the law.