How Will State and Federal Law Alter Compounding in 2013?

Every compound pharmacy should be preparing for the passage of new Federal and State laws and regulations addressed specifically to compounding. This article focuses on anticipated Federal legislation. Expect a State law update soon.

The strongest predictor of Federal laws impacting compounders, can be found in a March 23, 2013 statement by FDA Commissioner, Margaret A. Hamburg, M.D. In the statement, Dr. Hamburg expressed the FDA’s condolences for the families whose loved ones had lost lives in the NECC tragedy but quickly turned her attention to the FDA’s role in preventing future tragedies.

The FDA’s wish list is clearly laid out for all compounders to read. Compounders can anticipate greater joint inspections by State Boards of Pharmacy and the FDA. The FDA has already inspected over 30 facilities in the last month (most of whom were sterile compounders) and “will continue” such efforts. The Commissioner refers to large scale sterile interstate shipping as “a new breed of specialty pharmacy compounding [that] has evolved [and] has outgrown the law, and can pose a threat to the health of the public.”

What type of legislation is the FDA Commissioner looking for? What type of legislation and rules can compound pharmacies anticipate by the end of 2013? Commissioner Hamburg asked Congress to draft legislation establishing minimum federal standards for firms that compound sterile drug products, and wants Congress to enhance the FDA’s authority to inspect pharmacies, asking for the “FDA [to] have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.” That means, whether or not you actually do sterile compounds, the FDA will likely have the authority to inspect your pharmacy. On the whole, the FDA Commissioner’s sights are clearly set on: a) sterile compounds made in advance of or without a prescription; and b) sterile compounders doing significant shipping across State lines.

Some specific predictions of new regulations relating to sterile products: 

  • new Federal quality standards for large scale compounding;
  • required Federal registration of compounding facilities so FDA knows their location and what drug products they are making; and
  • mandatory reporting to FDA of serious adverse reactions.

Some specific predictions of new regulations relating to non-sterile products:

  • FDA authority to examine a pharmacy’s records to locate the cause of an outbreak or other violations of the law
  • prohibiting compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application
  • requiring compounded drug products to have clear label statements identifying the nature and source of the product

The FDA is not alone in throwing its suggestions into the ring, as part of the national discussion and focus on compounding pharmacies. In November 2012, Congressman Ed Markey of Massachusetts submitted his own proposed bill, then referred to as the VALID Act, which would have placed serious requirements on pharmacies seeking to mail a significant amount of medications out of state. More recently, in December 2012, the FDA held a public meeting in which it invited representatives from the various State Boards to discuss future regulation. The consensus was to suggest a three-tiered framework focusing on “traditional compounding,” “non-traditional compounding,” and “manufacturing compounding.” Some of the conclusions from this meeting appear to have formed the basis for Dr. Hamburg’s most recent suggestions.

Therefore, compound pharmacies of all types need to be prepared for changing laws and new regulatory agencies with new levels of oversight. The best way to be prepared is to develop protocols, policies and procedures for handling FDA inspections and carrying out product recalls, if necessary.

Frier Levitt assists pharmacies in developing protocols and Standard Operating Procedures for addressing FDA inspections, and for handling product recalls for contaminated products. If your pharmacy mails compounded prescriptions, well-drafted procedures and SOPs can help your pharmacy be prepared, ensure compliance, save money and avoid future liability. Contact Frier Levitt to stay ahead of the curve.