503B Outsourcing Facilities Help Counter Drug Shortages Due to COVID-19

Demand on the human side will continue to challenge the availability of veterinary medications, due to COVID-19. Pain medications, such as hydromorphone and fentanyl, as well as sedatives and anxiolytics, such as midazolam are among those on the short list.

Even as the supply chain begins to catch up with demand, it is anticipated that wholesalers will allocate stock to physicians before veterinarians, according to Melissa King, PharmD, director of Manufacturing Operations at Epicur Pharma, a 503B outsourcing facility. The FDA recently issued guidance that encourages 503B outsourcing facilities to help close the gap in the supply chain.

Veterinarians are used to working with 503A compounding facilities to compound human drugs in doses and routes of administration for individual veterinary clients. They may be less aware of the 503B outsourcing facility where they can purchase and stock larger quantities for distribution by the veterinarian at the clinic. 503A facilities create 1 product for an individual patient prescription; 503B outsourcing facilities can create products in bulk. They must operate in accordance with current FDA Good Manufacturing Practices (cGMP) just like a pharmaceutical manufacturer does, which ensures that clients receive consistent drug therapy over time. They essentially follow the same rules as manufacturers of generic and branded medications do.

Therefore, 503B outsourcing facilities can fill a critical need for veterinarians.

Since the FDA guidance was released, 503B outsourcing facilities are ramping up production of the drugs in shortage, including hydromorphone, ketamine, fentanyl and midazolam. There are 76 registered outsourcing facilities in the United States, some of which specialize in veterinary medicine. Source: Image courtesy of Epicure Pharma

Stokes Healthcare, a 503A facility, in Mount Laurel, NJ, recently opened Epicure Pharma, a 503B outsourcing facility. Epicur Pharma brings a unique advantage to the veterinary industry because it has a large selection of manufactured drugs that are traditionally compounded for animal health. Every drug manufactured by Epicur must meet FDA standards and practices. The facility’s offerings include tacrolimus ophthalmic drops, buprenorphine injection, and gabapentin MINI-MEDS tablets among others. Epicur products are distributed directly to veterinary hospitals from its outsourcing facility and are offered through Stokes Pharmacy for individual patient prescriptions.

For more information, visit www.epicurpharma.com to see the complete product portfolio.

CHECK OUT these websites for more information

https://www.fda.gov/media/137031/download

www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities