There are many reasons why veterinarians turn to compounded medications, as explained by a panel speaking on the topic of “Unlocking the Power of Compounding in Veterinary Practice,” sponsored by Wedgewood Pharmacy. The panel included: Patsy Douglas, RPh, FACVP, FAPC, Pharmacist Supervisor, Wedgewood Pharmacy; Ernie Ward, DVM, co-owner and co-founder, Vertical Vet in North Carolina; and Brian Carlson, MBA, hospital director, Old Derby Animal Hospital in Massachusetts.
Compounded medications are invaluable when there is a lack of commercially available product or when there is a need for:
- dose and dosage form options
- flavoring for compliance
- a product that reduces individual and species-specific allergic responses or toxicity concerns
- a substitution for medication discontinued in the human market
Carlson emphasized that choosing the right compounding pharmacy is important to ensure quality, and it is appropriate to ask specific questions when considering a compounding partner. He recommended ensuring that a pharmacy is accredited by the PCAB (Pharmacy Compounding Accreditation Board) and asking whether products are stability tested for the longest “beyond-use-dates” (BUDs), especially since those regulations are changing (see below). The company should have a dedicated Quality Control department that ensures high sterility standards, performs pH testing on various compounds, and uses chemicals acquired from FDA-registered suppliers. Wedgewood Pharmacy complies with all of these important quality control standards.
Pharmacies are categorized as either 503A state-licensed pharmacies (SBOP), or as 503B, which are FDA-registered outsourcing facilities with primary oversight by the FDA and SBOP. Those listed as 503B provide the longest BUD dates.
Douglas explained the new FDA regulation changes that went into effect in 2023. She said the FDA GFI # 256 established lists that define which compounded preparations are available for office stock—this limits the amount of drugs kept in clinic for later use. Other important points in the new FDA regulation include:
- Practitioners need to justify a clinical difference and medication rationale for using a compounded medication instead of an FDA-approved drug. This addresses patient difficulties with allergies, taste, and dose.
- Veterinarians are required to report adverse events and product defects to the FDA.
Carlson noted that with many compounded preparations moving to the “not listed” list, veterinarians have been impacted by delays in treatment, especially because this guidance does not address backorders. There is also the inevitable delay in patient care while waiting for prescription delivery.
BUD Changes
There were additional changes that occurred in November 2023 that apply to beyond-use-dates (BUDs), which indicate the dates after which a medication should not be used. It is notable that the BUDs are assigned at the time of compounding, before medications are in the veterinarian’s hands.
USP <795> refers to non-sterile compounded medications and distinguishes between aqueous and non-aqueous forms based on water activity in the finished compound.
Aqueous dosages with BUDs of 180 days were reduced to 14 days for those compounds prepared without preservatives but refrigerated, and 35 days for medication with preservatives.
Non-aqueous doses with BUDs of 60–365 days changed to 90 days for oral and 180 days for solids, semi-solids or topical liquids.
USP <797> refers to sterile compounding, both aseptically processed and terminally sterilized.
For aseptically processed drugs (assembled from sterilized components), prior average BUDs of 180 days changed to 60 days at room temperature, 90 days in the refrigerator, and 120 days if frozen.
For terminally sterilized drugs (in their final container), BUDs changed to 90 days at room temperature, 120 days with refrigeration, and 180 days if frozen.
Take-Home Message
The panel described strategies to enable veterinary practices to best manage these new requirements, such as establishing good communication procedures, especially for issues that most impact clients and patients. This can be accomplished by outreach experts (vet techs, receptionists, associates), personalized messaging, and social media that reaches a broad audience.
It is also recommended that practices re-evaluate workflow protocols and designate essential team members to request, approve and dispense medications as well as anticipate and authorize refills when appropriate.
An additional recommendation is to leverage inventory control through practice management software to filter and search for listed compounded drugs affected by the November 2023 changes.
Carlson urged practices to embrace technology by using online pharmacy platforms with 24/7 availability along with auto-ship options that dovetail with treatment protocols and recommendations.
Editor’s note: You can register watch a free recording of “Unlocking the Power of Compounding in Veterinary Practice” from Wedgewood Pharmacy.
