Manufactured versus compounded veterinary drugs: There is no comparison
The process of sourcing veterinary pharmaceuticals can be challenging. Veterinarians and their purchasing managers must find a balance between drug quality, cost, availability, and patient needs. Thankfully, more sourcing options are available today than ever before.
Traditional drug manufacturers and compounding pharmacies
Up until the last few years, veterinary hospitals and clinics were limited to two main options when purchasing medications:
- Mass-market drugs – At one end of the spectrum, some traditional manufacturers produce mass-market drugs which are often readily available and have been through stringent quality and safety testing. However, these drugs are targeted primarily to human needs and aren’t offered in concentrations and delivery formats suitable to veterinary patients.
- Traditional compounding pharmacies–The other end of the spectrum offers traditional compounding pharmacies, often referred to as 503A pharmacies, such as Stokes Pharmacy, Wedgewood Pharmacy, and your neighborhood compounding pharmacy. The pharmacies can offer patient-specific customized medications, compounding drugs in a variety of strengths, flavors, and delivery formats that meet the unique needs of the veterinary industry. Because commercially available drugs are often unpalatable to animal patients and are offered in concentrations that aren’t the right fit, customization through drug compounding has taken a central role in veterinary healthcare.
However, 503A compounding pharmacies can only produce medications on a patient-specific prescription basis and can’t produce drugs in large batches. They also aren’t required to adhere to the same quality standards as drug manufacturers, so there can be variances in drug integrity and safety.
503B outsourcing facilities—a “sweet spot” in drug manufacturing
While both mass-market drugs and 503A compounded prescriptions have their place, there are times when neither of these choices addresses the needs of veterinary healthcare providers and their patients. Fortunately, there is another option available.
The demand for manufactured veterinary medicines is expected to increase due to two growing factors:
- Increasing client requests for various dosage forms that will improve patient compliance
- The availability of suitable generic veterinary medications remains unreliable
When high-quality manufactured drugs are required in larger quantities, such as in veterinary hospitals and clinics, 503B outsourcing facilities can fill a ‘sweet spot’ between traditional 503A compounding pharmacies and large drug manufacturers.
503B outsourcing facilities came into existence in 2013 with the passage of the Drug Quality and Security Act, and like major manufacturers of human pharmaceuticals, these facilities:
- Are required to comply with the Current Good Manufacturing Practice (cGMP) regulations established by the Food and Drug Administration (FDA), ensuring the production of high-quality veterinary medications.
- Perform testing for potency, purity, stability, sterility, and endotoxins (if applicable) on every batch of medication produced.
- Sell drugs to healthcare facilities without a patient-specific prescription, referred to as “outsourcing.”
- Manufacture larger batches of ready-to-use drugs needed for office use in veterinary hospital and clinic settings.
Unlike large drug manufacturers, 503B outsourcing facilities provide . . .
(Continue reading to learn more about the 503B difference—plus our video breaks down the basics of 503B manufacturing!)
Photo courtesy of Epicur Pharma