Nov 15, 2013 | Derek Davis

Pharmacy Update: Recent Compounding Pharmacy Legal Developments

By: Derek Davis

Pharmacy Update:  Recent Compounding Pharmacy Legal Developments

Legislatures and Regulators Step Up Efforts to Broaden Regulatory Oversight of Compounding Pharmacies

     Federal and state legislatures, together with the FDA and State Boards of Pharmacy, have all been very active in 2013 in redefining and broadening regulatory oversight of compounding pharmacies in the wake of recent negative publicity.  Addressing operational deficiencies and keeping current on the evolving legal and regulatory requirements can be challenging for compounding pharmacists and pharmacy owners.  This article will briefly discuss recent developments concerning FDA inspections of pharmacies (including some background on current FDA authority), federal and state legislative efforts to expand regulation of compounding pharmacies, and provide a checklist for pharmacy/pharmacist preparation for upcoming changes in the current legal environment.

FDA Inspections

     In an effort to support its own bid to broaden and oversee compounding pharmacies, the FDA inspected dozens of pharmacies with the assistance of various state boards of pharmacy in 2012 and 2013.  Understanding the background, history and recent efforts of the FDA to regulate compounding pharmacies can assist in preparing for the future.

Background:  FDA’s Current Authority to Inspect Pharmacies

     Although the FDA is allowed to inspect a compounding pharmacy, its powers and jurisdiction is limited. According to the Food, Drug and Cosmetic Act (FDCA) Section 704 (21 USC 374):

  • FDA inspectors are authorized to enter any facility that manufactures, processes, packs, or holds drugs and inspect the facility, pertinent equipment, materials, containers, and labels.
  • Records, files, and papers are not required to be inspected as long as the pharmacy is in conformance with local laws, dispenses prescription drugs upon presentation of prescriptions from prescribers, and does not manufacture or process drugs for sale other than in the regular course of business of dispensing or selling drugs at retail.

     One factor to consider includes the delineation between compounding and manufacturing drug products. In general, sterile compounded products must follow US Pharmacopeia (USP) 797 guidelines, and manufactured drug products follow the FDA’s current Good Manufacturing Practice (cGMP) regulations. Upon inspection of the compounding pharmacies, the FDA has been making observations based on the cGMP regulations from 21 CFR parts 210 and 211 (2012).

     Pharmacy inspections can occur at any time by the state board of pharmacy, and in certain cases, the FDA may inspect the pharmacy. It is important to know which agency can inspect your pharmacy, which records you must present for investigation, and what types of responses are appropriate or authorized.

Areas of Focus from FDA Inspections

     In reviewing the FDA inspection reports on sterile compounding pharmacies, certain observations were made by the FDA investigators. The full reports are public and can be accessed from the FDA’s website at:

     Among others, an overall review of the FDA inspection reports described deficiencies in the following areas, which were often derived from the cGMP standards:

  • Appropriate gowning apparel in the clean room (21 CFR 211.28)
  • Proper aseptic technique when compounding sterile drug products (21 CFR 211.113)
  • Sanitation of supplies and materials that are brought into the clean room (21 CFR 211.42)
  • Written standards and procedures for: product testing, cleaning, sterilization (21 CFR 211.110)
  • Maintenance and cleaning of equipment and utensils to prevent contamination (21 CFR 211.67)
    • Including documentation of laminar flow hood certifications (21 CFR 211.42), filter inspections, air supply and air pressure monitoring (21 CFR 211.46), and cleaning validation studies (21 CFR 211.67)
  • Environmental monitoring programs, such as air and surface sampling for contaminants (21 CFR 211.42)
  • Testing of drug products for potency, sterility, and stability before release (21 CFR 211.165, 166)
  • Written procedures and documentation of media fill tests that represent the worst case scenarios (21 CFR 211.113)

Federal Efforts to Broaden FDA Oversight

     When the legislature is not focused on keeping the government operating from a budget perspective, it has been fairly active in introducing and considering legislation that will empower the FDA with broad powers to regulate compounding pharmacies.  Although several bills have been introduced, the most current iteration has been reported by some as quite likely to pass.  The current bill advancing in Congress, HR 3204, The Drug Quality and Security Act, greatly expands the FDA's jurisdiction over compounding pharmacies. Although quite lengthy, it broadly empowers the FDA to regulate compounding pharmacies, and eliminates the provisions of the Food Drug and Cosmetic Act that were previously determined to be unconstitutional in an effort to clarify the FDA’s authority and responsibility.

     The bill contains two distinct sections (titles) addressing different issues.  Title I, the Compounding Quality Act, broadens the FDA’s authority and addresses the need for compounding pharmacies to register as “Outsourcing Facilities” under specific circumstances.  Title II, the Drug Supply Chain Security Act, purports to create a national standard for tracking and monitoring drug supply chains with a goal of eliminating counterfeit drug trafficking.

     The US House of Representatives passed this bill on September 28, 2013, and it now moves to the Senate for consideration. Many pharmacy political commentators expect this bill to pass and be signed into law.

State Efforts to Broaden Regulation of Compounding Pharmacies

     Texas and California, together with dozens of other states, have been active in 2013 in passing bills to increase regulation and scrutiny of compounding pharmacies. 

Texas – The Texas legislature passed SB 1100, giving the Texas State Board of Pharmacy the power to regulate and inspect out-of-state compounding pharmacies.  The bill requires that out-of-state compounding pharmacies reimburse the Board for travel expenses relating to inspections and requires an inspection before a new compounding pharmacy can be licensed.  The bill also expands the inspection requirements for compounding pharmacies with existing licenses to complete an inspection before renewal.  Compounding pharmacies must also notify the Board of certain adverse events attributable to sterile compounded preparations, including after pharmacy-initiated recalls.

California – On October 8, 2013, the governor signed into law SB 294, requiring that all compounding pharmacies obtain a separate license for compounding sterile drug products, inhalation medications or medications administered into the eye.  The law also bans out-of-state pharmacies from shipping compounded products into the state without proper licensure under this law.  The law takes effect on July 1, 2014.  The bill requires the pharmacy board to adopt standards for licensure and regulation of compounding pharmacies based upon national standards, leaving a number of open questions about how this will be carried out.  The bill also provides for criminal penalties under California law for violations. In addition to adopting a new license fee of $780.00, the bill requires the pharmacy board to report to the legislature on or before January 1, 2018, concerning board activities relating to the inspection and licensure of non-resident pharmacies, indicating that additional modifications or additions could be made in the next few years.

What Should Pharmacies Do?

     Pharmacists and pharmacies should prepare for broader regulation and detailed scrutiny of compounding and business practices.  The following checklist may be helpful to determine the level of preparation necessary for an individual business:

            1.  Assess compliance with current compounding pharmacy laws;

            2.  Address the need for specific policies and procedures governing sterile compounding;

            3.  Review the FDA inspection reports to understand the focal issues raised by inspectors;

            4.  Prepare personnel for a possible State Board and/or FDA inspection, including proper personnel to be involved, the development of an action plan concerning document requests and interviews, and notification and review procedures for legal questions.

     For any questions or information requests concerning this article or the underlying bills discussed in it, please contact me.