FDA COMPOUNDING COMPLIANCE POLICY GUIDE UPHELD BY HOUSTON FEDERAL COURT

FDA COMPOUNDING COMPLIANCE POLICY GUIDE UPHELD BY HOUSTON FEDERAL COURT in a March 31 decision by Judge David Hittner. The policy guide had been challenged in a suit brought against FDA by Professionals and Patients for Customized Care (P2C2) in May 1992. The suit alleged that the agency did not allow the public opportunity to comment on its compounding Compliance Policy Guide issued three months earlier. P2C2, a Houston-based organization made up of over 600 pharmacists, maintains that FDA's guide was a rule issued without appropriate notice-and-comment procedures. P2C2 was represented by John Simpson of Fulbright & Jaworski.

Judge Hittner found that the guide is not a blanket prohibition against compounding. "FDA distinguishes between pharmacy activities that it would consider to be "traditional extemporaneous compounding" and pharmacy activities that it would consider to be manufacturing," Hittner noted.

The FDA guide, the judge added, is aimed at "drug manufacturing that takes place in pharmacies." The guide leaves "agency decision-makers free to exercise their discretion." The guide is not a rule, the judge states, and "simply because FDA employees, in informal communications, may have referred to the [guide] as something to be 'enforced' does not transform the [guide] into a binding regulation with the force and effect of the law."

The issue of compounding continues to persist. A recent spate of interest was triggered by an April 25 TV news magazine report by the ABC show "Day One." Both ASHP and APhA wrote letters to ABC criticizing the news magazine's coverage.

American Pharmaceutical Association Exec VP John Gans said that APhA "in no way [minimizes] any harm resulting from improperly prepared products; however, the public should be reassured that the medicines they receive from their pharmacists, whether commercially manufactured or compounded in the pharmacy are, with very few exceptions, of the highest standards."

American Society of Hospital Pharmacists Exec VP Joseph Oddis told ABC that the news show "did not provide a balanced, accurate or realistic picture of prescription compounding in the U.S."; "failed to point out the...medical need fulfilled by compounding that is correctly done"; and may encourage patients to "resist or fear the vast majority of medically necessary and safe uses of compounded medication."

Senator Bumpers (D-Ark.) was prompted by the broadcast to query FDA Commissioner Kessler about the regulation of pharmacy compounding at a recent meeting of the Senate Appropriations/Agriculture Subcommittee. Kessler responded that most pharmacists engage in the practice in a "reasonable fashion." FDA Associate Commissioner for Regulatory Affairs Ronald Chesemore noted that agency policy is to leave regulation to state boards of pharmacy ("The Pink Sheet" May 16, p. 5).