By Karla L. Palmer –
Last week, Senator David Vitter (R-LA) introduced S. 1406, the Saving Access to Compounded Medications for Special Needs Patients Act, to amend Section 503A of the Federal Food, Drug, and Cosmetic Act. The amendment addresses confusion over a compounding pharmacy’s “distribution” of compounded preparations and, specifically, compounding for office use (i.e., compounding preparations that are not based on a prescription for an individually identified patient). As with other provisions of Section 503A, the amendment would exempt compounding pharmacies from the new drug (Section 505), adequate directions for use (Section 502(f)(1)), and current good manufacturing (cGMP) requirements (Section 501(a)(2)(B)) if the drug product is “compounded and distributed to a practitioner where, as permitted under State law, the drug product is used in the treatment of or administered to a patient of the practitioner....” The proposed provision addresses what many believe is a battle between FDA, various states, and an oversight on the part of Congress concerning office use compounding - as permitted by state law (based on the legislative history concerning re-enactment of Section 503A as part of the passage of Title I of the Drug Quality and Security Act in November 2013).
The amendment would also require compounders to comply with United States Pharmacopeia standards, including the General Chapters related to the compounding of drug products. And, it would provide a needed amendment to the provisions related to the Memorandum of Understanding (“MOU”) (at Section 503A(b)(2)(D)(3)(b)), which, in the current statute, requires states to sign an MOU that “addresses” the “distribution” of inordinate amounts of compounded drug products shipped interstate. FDA attempted to garner support for its draft MOU back in 1998, prior to legal challenges to the constitutionality of Section 503A, but States and FDA never came to an agreement on its terms. FDA recently proposed a new draft MOU (as blogged about here) and is awaiting comments from interested parties (the comment period expires in 23 days) prior publishing a final version. As the statute currently reads, if a State does not enter into the final MOU with FDA, then compounders within that State are limited to distributing amounts out of state that do not exceed 5 percent of the total prescription orders “dispensed or distributed by such pharmacy or physician.” The amendment would eliminate the confusing and contentious requirement that the MOU “address distribution” of inordinate amounts of compounded preparations shipped interstate, and instead require the MOU to “provide for appropriate investigation of complaints relating to compounded drug products distributed” out of state. It also would eliminate requirement of FDA to consult with the National Boards of Pharmacy in the development of the standard MOU; instead, it would require FDA to consult with States. We will keep you posed concerning movement of the bill.