This article first appeared in the December 2010 issue of drugtopics.com
A compounding pharmacy in Florida, Franck's Lab, Inc., which engages in veterinary compounding, has been embroiled in a struggle with the FDA since it compounded a vitamin supplement for administration to 21 polo ponies during the U.S. Open Polo Championships in April 2009. When they were injected with the compounded vitamin supplement, all 21 ponies collapsed and died.
As a result, FDA sought to obtain a preliminary injunction against the pharmacy to prevent it from engaging in further veterinary compounding.
FDA makes its case
The agency argued that the pharmacy was violating a compliance policy guidance issued by FDA in 2003 for purposes of clarifying its interpretation of the Animal Medicinal Drug Use Clarification Act. FDA asserted that any "compounding from bulk substances," such as the Florida pharmacy had done, "or unapproved drugs renders the compounded drugs unsafe as a matter of law, and thus adulterated in violation of 21 USC § 351(a)(5)." FDA argued that the bulk drugs constitute new drugs and therefore require FDA regulatory approvals before they may be introduced in interstate commerce.
The pharmacy responds
The pharmacy responded by asserting that FDA has no authority to ban veterinary drug compounding from bulk product. In its defense, the pharmacy stated that the "use of bulk ingredients to compound commercially unavailable preparations is a core part of the traditional pharmacy practice" which is left for purposes of oversight to the individual states and not to the federal government and FDA.
The pharmacy did not dispute that FDA may have regulatory authority over the manufacturing of veterinary pharmaceuticals if it can show that the pharmacy is truly engaged in the "manufacturing" process. But, the pharmacy pointed out, FDA is not permitted "to override state law and impose a blanket ban on traditional pharmacy compounding practices."
The pharmacy also noted that the legislative history of the Federal Food, Drug, and Cosmetic Act (FDCA) proves that Congress intentionally left regulation of compounding to state regulatory oversight as part of pharmacy practice, while preserving regulatory oversight of manufacturing as a task of the federal government.
Finally, the defendant pharmacy stated that even if the FDCA provided FDA with the right to regulate veterinary compounding, FDA would need to promulgate regulations through formal rule-making procedures that would include a notice-and-comment period, rather than through the issuance of an informal compliance policy guide.
In summary, the judge denied FDA's motion for preliminary injunction without issuing an opinion. However, the court is currently reviewing the request for permanent injunction.
This case illustrates the important point that legal tension arises when pharmacy compounding is alleged by FDA to reach the level of manufacturing. FDA regulates manufacturing, while state laws and regulations govern pharmacy compounding. If FDA is able to demonstrate that a compounding pharmacy was in fact engaged in manufacturing, then it will be able to exercise its authority over the pharmacy, and state regulatory oversight would not apply.
Other cases have analyzed this matrix, and this body of law continues to evolve as different parties and efforts - including by the federal government through the FDA; by state governments and boards of pharmacy; and through the various pharmacy practice acts - attempt to draw the fine line whereby compounding and manufacturing are defined.
These articles are not intended as legal advice and should not be used as such. When a legal question arises, an attorney familiar with drug and pharmacy laws should be consulted.
||Ned Milenkovich, PharmD, JD, is a member at McDonald Hopkins LLC and chairs the Drug & Pharmacy Industry Practice Group. He is a member of the Illinois State Board of Pharmacy. He can be reached at 312.642.1480 or at firstname.lastname@example.org.
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