Bioidentical Hormones - U.S. Senate Special Committee on Aging

244
Report on State Laws and Regulations
Related to Pharmacy Compounding
David G. Adams and Todd H. Halpern'
While the states have the primary role in regulating pharmacy practice, Congress
has since the enactment of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938
provided general federal oversight over the promotion, preparation, and dispensing of
drug products by pharmacists. In the current debate over the appropriate role of the U.S.
Food and Drug Administration (FDA) in regulating pharmacy compounding, opponents
of FDA regulation argue that state regulation obviates the need for significant FDA
oversight. They oppose FDA enforcement initiatives under the FDCA, as well as
recently legislative proposals, intended to protect patients with regard to compounded
drugs. The current and proposed protections under the FDCA that are at issue include,
among other things, the following:
(1) Requirements that pharmacists disclose important information about
compounded products to patients and physicians. Patients who are
dispensed compounded drugs are generally not informed of the special risks
posed by compounded drugs and are generally unaware that they are even
receiving a compounded drug.
(2) Standardsfor active ingredients that may be used in compounded
products. Some drugs are compounded from ingredients that have never been
approved by FDA for any medical use or that fail to meet minimal reference
standards.
(3) Documentation of medical necessity for compounded drugs. Many
compounded drugs are essentially copies of FDA-approved drugs that appear
to have no medical justification.
(4) Standardsfor compounding sterile products. Many compounded drugs
must be sterile but fail to meet sterility standards for FDA-approved drugs, or
even lesser pharmacopoeial standards.
(5) Restrictions on compounding of copies of commercially available products
that are approved by FDA. Compounded drugs are not demonstrated safe
and effective and substitution of compounded drugs for FDA-approved drugs
may subject patients to greater risks.
It is reasonable to ask whether and how the states provide these and other
protections to patients. The capacity of the states to protect patients with regard to
compounded drugs is a function of legal authority (state laws and regulations) and, where
there is legal authority, a function of enforcement policies and resources.
I David Adams and Todd Halpern are attorneys at Venable LLP, Washington, D.C. This report was
prepared for Sepracor Inc.