Pew reports find weaknesses, best practices in compounding pharmacy regulation

State agencies that regulate compounding pharmacies often lack the authority to require compliance with appropriate standards, according to a recent report issued by the Pew Charitable Trust. In two related reports, Pew researchers assessed the extent to which state regulatory agencies oversee the safe operations of compounding pharmacies and recommended best practices for the agencies’ use.

Regulation of compounding pharmacies

Compounding pharmacies prepare drugs that are not commercially available. Under Federal Food, Drug, and Cosmetic Act section 503A, compounding pharmacies are permitted to prepare medications by prescription for the use of an identified patient. However, manufacturers began to use compounding pharmacies as outsourcing facilities to prepare larger batches of drugs. These outsourcing facilities challenged the restrictions on compounding pharmacies that prohibited advertising and solicitation of prescriptions. In 2012 and 2013, contaminated drugs manufactured by compounding pharmacies caused multiple injuries and deaths (see FDA inspects 29 compounding pharmacies, continues to find violations, Health Law Daily, April 12, 2013) Congress enacted the Drug Quality and Security Act, including the Compounding Quality Act. This law provided for FDA regulation of outsourcing facilities. The regulation of traditional compounding pharmacies remains under state control.

State oversight

The Pew researchers surveyed state boards of pharmacy and reviewed other materials to determine how states regulated compounding pharmacies. The 43 states that responded to the survey varied in their definition of compounding, the extent of their tracking of the activities of compounding pharmacies, the standards they enforced, and the enforcement actions available to them. For example, most states defined “compounding” to include combining two or more ingredients, but some definitions included repackaging, diluting, pooling, and/or reconstituting.

Many states do not track the pharmacies that perform compounding functions. A few require separate licensure. Of the 43 that responded, 34—79 percent—required compounding pharmacies to comply with at least some of the standards published by the United States Pharmacopeia (USP) in Chapter 797, but 13 of them did not require compliance with the entire chapter. Of the eight that did not apply USP chapter 797 at all, seven reported that policy changes to adopt part or all of Chapter 797 were pending. A few required more extensive training than the USP for some activities. In particular, some states required hands-on training and evaluation in which the evaluator observed the participant compounding a drug.

Enforcement authority

Most states did not track the violations of compounding pharmacies separately from retail pharmacies. Most did not require compounding pharmacies to report voluntary recalls either to the state or to the FDA. Eighty-eight percent of the responding states required pharmacies to report the number of drugs that they compounded, but only 30 percent required reporting of adverse events.

Thirty percent of states had the authority to require a compounding pharmacy to recall a product, while 44 percent did not. The staff who responded on behalf of the remaining 26 percent of states did not know whether their agencies had the authority to require a recall.

Best practices

An advisory committee compared states’ monitoring and enforcement practices and proposed recommended best practices for states to adopt if they could. The recommendations included:

  • application of the quality standards of USP Chapter 797;
  • identification of pharmacies that perform sterile compounding;
  • separate tracking of violations of requirements governing sterile compounding;
  • requiring training of all pharmacists who either perform or supervise sterile compounding;
  • annual inspections of compounding pharmacies; and
  • harmonizing state requirements for compounding without a prescription with those of federal law.