The U.S. Food & Drug Administration announced Nov. 7 that it is withdrawing draft Guidance for Industry (GFI) #230, “Compounding Animal Drugs from Bulk Drug Substances” in order to clarify that the agency does not plan to finalize the current draft but instead intends to issue a new draft for public comment next year.
The draft guidance issued in May 2015 proposed conditions under which FDA generally would not intend to take action against the compounding of animal drugs from bulk drug substances, with the goal of making such animal drugs available for patient care without jeopardizing the safety of animals and humans or compromising the animal drug approval process, the agency said.
Current law does not permit the compounding of animal drugs from bulk drug substances, but FDA said it recognizes that there are circumstances where there is no approved drug that can be used or modified through compounding to treat a particular animal with a particular condition. In those limited situations, it said an animal drug compounded from bulk drug substances may be an appropriate treatment option.
After reviewing comments submitted to the docket for the draft GFI, FDA decided not to finalize the current draft guidance and will instead develop and issue a new draft guidance. In developing the new draft, FDA said it will carefully consider the issues specific to compounding animal drugs, including the significance of using compounded drugs as a treatment option in various veterinary settings and animal species.
FDA intends to publish the new draft for public comment in early 2018. As FDA develops a new draft guidance, it will continue to focus on the safety of compounded animal drugs and intends to take action if the agency becomes aware of an animal or human safety concern associated with the use of an animal drug compounded from bulk drug substances. In the interim, veterinarians or other interested stakeholders are encouraged to contact FDA’s Center for Veterinary Medicine at AskCVM@fda.hhs.gov if they have questions regarding compounding animal drugs.
In response to this action, the Animal Health Institute (AHI) said the withdrawal "endangers animal health by failing to curb illegal activity."
AHI said it recognizes that there are unmet medical needs where no approved product is available. Therefore, a limited amount of this kind of compounding is necessary to meet those needs when the life of the animal is threatened, AHI said, noting that the draft guidance was FDA’s attempt to clearly define the instances where enforcement discretion would be used to permit this needed compounding.
“Withdrawal of the guidance document does not change the law,” AHI president and chief executive officer Alex Mathews said. “Until FDA better defines and clarifies this issue, veterinarians and their patients are at risk.”
The guidance was an effort to curtail widespread illegal activity in which compounding pharmacies act like manufacturers by illegally making large quantities of compounded drugs from bulk substances and marketing them to veterinarians as less expensive or more convenient alternatives to approved products, AHI said. Veterinarians and animal owners should remember that compounded products have not been evaluated by FDA for safety, efficacy and proper manufacturing practices, and there is no assurance that the pharmacy will take any liability for adverse reactions.
“We continue to support legal compounding that is done for an individual patient under the prescription of a veterinarian using an approved product,” Mathews said. However, “the continuing and unrestrained compounding of drugs from bulk drug substances imperils animal health by placing animals at risk from unsafe or ineffective treatment. We urge FDA to move quickly to draw a clear line between compounding activity it will permit to meet medical needs and illegal activity and to aggressively enforce against illegal activity."
AHI represents companies that make medicine for animals. Its members develop and produce medicines that help pets live longer, healthier lives and contribute to safe food by keeping food animals healthy by furthering the discovery, development and approval of medicines that promote animal health in a research-driven industry. Since 1941, AHI has helped create an environment that fosters robust research and development of innovative and needed veterinary medicines.