Rx & The Law

To Compound or Not To Compound?

by Donald McGuire, R.Ph., J.D.
Professional Claims Attorney
Pharmacists Mutual Insurance Company

The FDA Modernization Act of 1997, which went into effect in November of 1998, contained a section addressing pharmacy compounding. The intent of this act was to clarify the difference between compounding and manufacturing. After defining a compounded product, the act exempts them from the new drug requirements of the Federal Food, Drug and Cosmetic Act (FDCA). In the past, the FDA had attempted to regulate compounding by calling all compounded products a "new drug" and therefore subject to the FDCA. The exemption in this act effectively removes compounding from the FDA’s jurisdiction and leaves it with the states’ boards of pharmacy. It is important for the pharmacist to know what products may be compounded under the FDA Modernization Act. Compounding a product outside of the requirements of the act is not exempted from new drug requirements and could be subject to FDA action.

Drug substances that comply with a USP or NF monograph may be used under the act. Additionally, drug substances that are a component of a FDA-approved drug may be used in compounding. The status of other substances or products is dependent on its inclusion on one of three lists. The FDA makes these lists pursuant

to its "notice and comment" rulemaking authority and the authority of the FDA Modernization Act. "Notice and comment" rulemaking is the most common method for administrative agencies to enact rules and regulations.

The first list is those substances which do not comply with an official monograph, but whose use in compounding is permissible. This "permissible list" is currently being devised through the efforts of the Pharmacy Compounding Advisory Committee and is almost complete. Among the substances under consideration are; bismuth citrate, ferric subsulfate, iodoform, and metronidazole benzoate.

The other two lists will contain products which may not be compounded. The first of these is the list of products which demonstrate clear difficulty in compounding. These are products where the act of compounding can be shown to have an adverse effect upon the safety or efficacy of the finished product. This will be the most difficult list of the three lists to devise and it is still some time from completion.

The third list is already completed. This is the "prohibited list". This list was proposed in the Federal Register on October 8, 1998 and was presented to the Pharmacy Compounding Advisory Committee on October 14 & 15, 1998. The comment period for this rule was shortened to 45 days because the FDA considered the products on this list to be a threat to public health. Among the comments received were those from consumers, pharmacists, a pharmaceutical manufacturer, and a pharmaceutical manufacturers organization. Comments were reviewed, the list was published March 8, 1999 and became effective April 7, 1999. These are products that have been removed from the market for safety or efficacy reasons. However, inclusion on this list is not a total ban on the substance’s use. Compounding certain dosage forms, for example, may be permissible. Consult the list for complete information. Even without the threat of time-consuming and expensive administrative actions, the liability implications of compounding a product with known safety or efficacy concerns should be enough to deter a pharmacist from compounding these products. Among the 59 products on the "prohibited list" are; adrenal cortex, bromfenac sodium, fenfluramine HCl, dexfenfluramine HCl, terfenadine, reserpine (oral forms containing more than 1mg), and zomepirac sodium. For the complete list and limitations, see 21 CFR section 216.24 or on the Internet at www.fda.gov/cder/pharmcomp/pcwd.pdf.

Pharmacists who compound must keep up with this evolving area of law and be aware of the legal status of the ingredients and products they are preparing. The regulation for the "Prohibited List" contains a provision that specifically provides for updating this list as other products are removed from the market. It is assumed that the other two lists will provide for additions or deletions as new information becomes available on their respective products. The FDA Modernization Act is drawing the boundaries for compounding’s "field of play". It is incumbent on compounding pharmacists to know the boundaries and stay "in-bounds".

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.