A pharmacies’ right to compound prescriptions came in jeopardy after the Food and Drug Administration argued that compounding creates new and unapproved drugs. In Medical Center Pharmacy, et al. v. Gonzalez, et al., No. MO-04-CV-130, District Court for the Western District of Texas, a suit was brought by 10 pharmacies against the Food and Drug Administration regarding the practice of pharmacy compounding. The court sided with the pharmacies saying that compounding ingredients to create a drug under a valid prescription does not create a new drug.
Drug compounding, a practice in which pharmacists manufacture prescription drugs from bulk ingredients, is traditionally done for medical reasons, such as when a patient is allergic to an inactive ingredient in the commercially manufactured drug. Typically, if a patient has a condition that off-the-shelf pharmaceuticals cannot meet, then customized compounded medicines are prescribed by physicians and prepared by licensed pharmacists. Every state legislature has authorized the compounding of drugs and state governments continue to regulate the practice.
In this ruling, the court went beyond its earlier finding that the FDA does not have the authority to classify compounded products as new drugs to add that the agency cannot prohibit pharmacists from using bulk ingredients to create customized medications. While the agency has never prohibited the use of bulk ingredients for human prescriptions, it had done so for animal products. Compounding proponents believed that the FDA would soon try to apply this policy to human drugs.
First, the Court ruled that compounded drugs do not fall under the new drug definitions and, therefore, are legal. Judge Junell explained: “If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval … It is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner.”
Second, the Court ruled that pharmacies are exempt from the requirement to submit to an FDA inspection of their records unless FDA can demonstrate that the pharmacy is not compliant with applicable state laws and does not operate as a retail pharmacy.
Third, the Court ruled that compounding from bulk pharmaceutical ingredients for non-food animals is legal. This is an important issue for animal owners and their veterinarians who prescribe compounded medications to treat a variety of conditions, many of which require medications that are only available by compounding bulk pharmaceutical ingredients. Without them, animals may needlessly suffer or even die. Until now, the FDA asserted that prescribing and preparing these treatments was illegal.
In 1938, Congress passed the Food, Drug, and Cosmetic Act to empower the FDA to require approval of new drugs made by pharmaceutical manufacturers. FDA began arguing in the late 1980’s that Congress intended for that law to apply to compounded preparations in addition to manufactured products. This meant that, according to the FDA, each compounded medicine was a “new, unapproved drug” subject to the same requirements as manufactured products. Because these requirements are inherently impossible for compounding pharmacists to meet, it meant that FDA considered all compounded preparations illegal.
While the FDA asserted that compounded drugs fall within the definitions of new drugs under 21 U.S.C. ยงยง 321(p)(l) and (v)(l), the term “new drug” is defined as “Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof…”
The court held that compounded preparations are not new, unapproved drugs. Two other issues in the case — the Food and Drug Administration (FDA)’s broad authority to inspect pharmacies’ records and pharmacies’ ability to compound from bulk active ingredients for non food- producing animals (e.g. pets, horses, zoo animals) — are still being considered by the judge.
Now, when you really need that special cocktail of Viagra, Bisquick and the little Purple Pill, you’re good to go.
