Surprise! FDA Quickly Issues Compounding Draft Guidances

December 2, 2013

By Douglas B. Farquhar – 

Well, that certainly didn’t take long.

FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies.  President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find that FDA has already issued three draft guidances on human drug compounding.  One restates prohibitions contained in earlier guidances from FDA.  Another tells pharmaceutical compounders how they can register as “outsourcing facilities,” the new “voluntary” category for certain compounding pharmacies.  The third tells outsourcing facilities how they should report the drugs they compound.  Links to the new guidances are included below.

Many of the provisions of the new Act, which was summarized in an earlier blog post, depend on issuance of regulations by FDA, and many of those regulations require input from an advisory committee that was disbanded years ago and hasn’t been reborn yet.  As a result, there had been some speculation that the impact of the new Act would be somewhat delayed.

Fear not: FDA is apparently very eager to provide a clear pathway for compounders to register as “outsourcing facilities,” which requires registration, payment of fees, opening of processes and documents to FDA inspections, listing drug products with FDA, compliance with cGMP, and reporting of adverse events, among other things.  So, although the Act became law only about a day ago, in terms of business days (since the government was closed Thanksgiving, Thanksgiving lendemain, and over the weekend), FDA today issued the draft guidances, which were clearly well into the preparatory phase prior to President Obama’s signature being placed on the legislation.  It is hardly surprising that FDA was so excited to move quickly.  Although FDA Commissioner Margaret Hamburg publicly indicated that the Act didn’t give FDA all the powers she wished she had, the Act does clear away confusion created by dueling court decisions as to status of the section of the Federal Food, Drug, and Cosmetic Act (FDCA) that it amended (Section 503A, found at 21 U.S.C. §353a).

Aside from the rapidity with which the guidances were issued, there is not much spectacular to report.  One of the guidances discusses procedures to register as an outsourcing facility under new section 503B of the FDCA, and the word on the street is that there are several compounding pharmacies that will be doing so shortly.  No fees will be charged until October 1, 2014.

The second guidance explains how quickly outsourcing facilities must report the drugs they have compounded in the prior six months.  Not surprisingly, this guidance says that “FDA encourages companies wishing to compound as outsourcing facilities to register with FDA immediately.”  The Guidance also states that if you register before June 2, 2014, you do not have to report this product information at the time of initial registration, as long as you do so within 2 months after registration.  FDA asks that the product information be submitted, for now, on an Excel spreadsheet attached to an email.  Microsoft should feel honored.

Finally, the third guidance provides clarity for compounding pharmacies that do not register with FDA as outsourcing facilities.  The draft guidance withdraws prior human drug compounding guidances, and restates that “FDA expects State boards of pharmacy to continue their oversight and regulation of the practice of pharmacy.”  The guidance states, however, that FDA intends to continue to cooperate with State authorities to “address pharmacy activities that may be violative” of the FDCA, including section 503A.  FDA expects to “employ a risk based enforcement approach,” and will give highest enforcement priority to compounded drugs and FDCA violations that pose the greatest health risk – which sounds like the approach that FDA has used since commencing its April 2013 Pharmacy Inspection Assignment.  The draft guidance underscores FDA’s position that a drug may not be legally compounded unless the facility is an “outsourcing facility” or the drug is compounded either for a specific patient, or in anticipation of a prescription for a specific patient based on historical ordering patterns.  The draft guidance also reiterates FDA’s historic  and controversial position that compounded drugs are new drugs (footnote 7) that would require approval if they aren’t compounded in strict compliance with the FDCA.  Finally, the draft guidance, which is explicitly not binding, also tells compounders that compounding must be performed in compliance with applicable chapters of the U.S. Pharmacopeia, which will doubtless perpetuate controversy: Section 503A of the FDCA itself requires that the ingredients used in compounding comply with USP, but does not require that the compounding process comply with USP.

FDA also issued pre-publication versions of two notices that will permit individuals to “nominate” drugs and bulk substances for addition to the “Do Not Compound” or the “Okay to Compound” lists called for in the statutory provisions governing compounding.  Yes, it is odd that these are “pre-publication” versions (they won’t be published until the December 4, 2013 Federal Register) and yet we have access to them now.  The “Do Not Compound” notice can be found here.  The notice establishing procedures for the “Okay to Compound” or “Positive” list (aside from those already authorized by statute) can be found here.