Wyeth questions the role of pharmacists to compound HRT

 In April, Wyeth Labs renewed its request (submitted last October) for increased FDA regulation of compounding pharmacies that prepare hormone replacement therapy (HRT). Wyeth markets the HRT called Premarin and asserts that the HRT medicines prepared by compounding pharmacies can pose serious health risks.

Here is some historical perspective. Prior to the 1950s, when commercially prepared drugs became widely available, compounding prescriptions to be taken by mouth or inserted rectally was the main function of community pharmacists. In fact, as late as the 1970s (at least in New Jersey), compounding was part of the licensing exam for pharmacists.

In the 1970s, with the advent of total parenteral nutrition, preparation (compounding) of injectables increased by hospital pharmacists. In the 1980s there was a resurgence of compounding in community pharmacies.

In an excellent review, Dr. David Newton states, “Since the early 1990s, most national pharmacy practitioner organizations have asserted compounding is an intrinsic professional practice to be regulated by state boards of pharmacy.” The FDA usually defers to state boards to oversee this practice. Yet, state boards lack inspectors to enforce compounding practice standards, and most boards of pharmacy do not examine the compounding proficiency of their licensure candidates.

The implications of Wyeth’s anticompetitive petition according to the International Association of Compounding Pharmacists, is the “end to the option of prescribing bio-identical hormone replacement therapy for those patients that need it.”

The FDA is reviewing Wyeth’s request.

7/16/06 10:40 JR