Survey: Veterinary Practices Are Uninformed About and Unprepared to Comply With New FDA Guidance Slated for October 1, 2022 Enforcement
A new nationwide poll of veterinary practices shows that 69% of veterinary practices are not confident they are prepared to comply with provisions of the Food & Drug Administration (FDA) Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances, which was finalized on April 13, 2022. The Guidance is slated to be "enforced" beginning October 1, 2022.
The survey, sponsored by Wedgewood Pharmacy, was fielded August 15 ? 17, 2022. The survey reports on the responses of 1,574 veterinary professionals in the U.S, all of whom work in practices that prescribe compounded medications for animal health. The company conducted the research to learn how knowledgeable its professional customers are about the FDA's Guidance and the changes it will require to ordering and prescribing procedures.
Marcy A. Bliss, CEO of Wedgewood Pharmacy, said: "We are working in a very focused way across our organization and industry not only to comply with the letter and spirit of this Guidance but to help our more than 60,000 veterinary prescribers to interact with us so that they, too, are in compliance when they order compounded medications, which are specially formulated for animal patients. FDA's new Guidance will change the way medication is obtained by veterinary practices for difficult-to-treat patients, those whose needs cannot be met by FDA-approved alternatives."
The Guidance details significant changes to the practices of pharmacy compounding and veterinary medicine. Yet 83% of those surveyed, just weeks before the Guidance is slated to be enforced, say they are not aware that the Guidance had been finalized; 90% said they were not aware that it will be enforced beginning October 1.
The survey tested how knowledgeable the respondents are with four key provisions of the Guidance:
- 74% are not at all knowledgeable (56%) or not very knowledgeable (18%) that medications for office use may be compounded from bulk drug substances only if those substances appear on one of two so-called "positive lists" and do not appear on a "negative list" published by FDA. (FDA calls drugs on these lists "listed" and "not listed.")
- 72% are not at all knowledgeable (52%) or not very knowledgeable (20%) that if a drug they want to prescribe as a compounded medication for an individual patient is made from a bulk drug substance, they must provide and a pharmacy must maintain documentation of the medical rationale for why they believe there is a "clinical difference" between the compounded medication and a commercially manufactured drug.
- 70% are not at all knowledgeable (55%) or not very knowledgeable (14%) that they will be required to report to FDA any adverse effects from compounded medications prescribed using FDA form 1932A.
- 81% are not at all knowledgeable (63%) or not very knowledgeable (19%) that FDA has defined a process through which anyone may nominate substances for inclusion on one of the three "positive lists." 63% say they are not likely (25%) or not at all likely (38%) to nominate a drug to FDA.
Meghann Abbott, assistant product manager for Wedgewood Pharmacy, noted, "Wedgewood Pharmacy is taking an aggressive lead in nominating Bulk Drug Substances to FDA for approval for office-use compounding. So far, we have nominated more than 50 families of medication. We have devoted significant resources to this nomination process because we strongly believe that veterinarians should be able to stock the medications they believe are critical to immediate patient care."
The most current FDA lists of nominated, under review, approved, and "not listed" bulk pharmaceutical ingredients are published by FDA.
With a majority of practices not aware that the Guidance has been finalized and soon will be enforced, the survey also showed that most practices have not taken steps necessary to understand or comply with its provisions:
- 65% of respondents have not and 20% don't know if "someone in your practice has reviewed the compounded medications you stock and frequently prescribe to determine if and how you will need to change treatment protocols related to requirements of the GFI."
- 72% of respondents have not and 18% don't know if their practice "has developed policies and procedures for how you will document your clinical rationales for prescribing a compounded medication as specified in the GFI."
- 70% of respondents have not and 17% don't know if their practice has "developed policies and procedures for how you will report adverse events as specified in the GFI."
- Respondents are not aware (16%) or not at all aware (70%) that they "will be expected to comply with both the GFI and conflicting state regulations."
The survey sample was not randomized and therefore the results cannot not be projected statistically to any other group. The results represent the opinions of the 1,574 veterinary professionals who responded to the survey.
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