Ever stop to think why you're in the beef business? Not why you like to be in it, but why you can be in it?
It's because someone wants to buy the product that comes out the other end of the processing plant. They want to buy it because it's good, good for you and safe.
Would you put a substance in your cattle that could damage the quality and safety of that end product? What about a substance that could harm your cattle, either directly or indirectly by not having its intended beneficial effect? Furthermore, what if using this substance could also damage the public perception of beef as being safe and wholesome? Are these potential outcomes worth the risk of “saving” money by doing it?
In 1962, the Food and Drug Administration Center for Veterinary Medicine (FDA/CVM) was provided authority to approve veterinary drugs through the Kefauver-Harris Amendment to the Federal Food Drug and Cosmetic Act. The FDA/CVM evaluates target animal and environmental safety, effectiveness of the drug for the intended purpose, and food safety prior to approving the label for a drug for use in animals.
FDA/CVM is also responsible for inspection of drug production plants and manufacturing processes, as well as many other drug-related issues. Recently, evaluation of the effect of an antibiotic on bacterial resistance development was added to this list.
It takes millions of dollars to develop a drug, run the studies to generate data to show it meets FDA/CVM requirements, and then create a manufacturing facility and source of raw products that pass FDA inspection. It's a long, rigorous process, but the result is a product safe for use in food animals and that protects their safety and the safety of the final product.
What if someone offered you a product “just as good” as (or better than) an approved product and possibly much cheaper? Such products may be in the form of repackaged approved products or products produced from unapproved “bulk” substances. This is called compounding.
Here are some basic facts you should be aware of when offered these products.
Compounding is allowed under specific circumstances when necessary to relieve pain and suffering of animals. This is an extra-label use of a drug, and must be done in compliance with 21 CFR Part 530, the regulations codifying the Animal Medicinal Drug Use Clarification Act (AMDUCA). Requirements include a valid veterinary-client-patient relationship (VCPR) and an appropriate medical rationale for the use. Cost or production purposes are not valid reasons for extralabel drug use.
The AMDUCA regulations may be accessed on the Web at the FDA/CVM Web site (http://www.fda.gov/cvm). Search “AMDUCA” and look for the 1996 Federal Register notice, or call 301/594-1755 to obtain copies. The section dealing directly with compounded products is 530.13 and is located toward the back of the Federal Register notice.
The FDA/CVM has just issued a revised compliance policy guideline on compounding (CPG 608.400, Compounding of Drugs for Use in Animals). Search for compliance policy guidelines on the FDA/CVM Web site and then select veterinary guidelines. Or, call the number given above. If you're considering using a compounded product, read this document, which describes how the agency intends to enforce regulations concerning compounding drugs for use in food animals.
There are concerns with all types of compounding, but perhaps the most serious threat to our industry is when individuals bypass the FDA/CVM approval process by obtaining bulk drugs to compound products that are then sold for use in place of approved products. The AMDUCA regulations clearly state that “Nothing in this part shall be construed as permitting compounding from bulk drugs…”. One of the requirements for legal compounding is that the ingredients must be approved animal or human drugs.
A bulk drug is a compound that could make up part of an approved product. An example would be an antibiotic powder that would then be combined with a carrier and packaged for distribution. For an FDA/CVM-approved drug, this powder would be tested for purity and potency and held to manufacturing tolerances. The facilities in which the final product is produced would also be inspected and held to FDA/CVM requirements. The drug, in its final form, would have been tested for animal and food safety as well as effectiveness.
Bulk drugs used in compounding unapproved products haven't met FDA/CVM requirements. The purity, potency, safety, effectiveness or shelf life of these products isn't known. Bypassing approval and production requirements allows sale of these products cheaper than approved products while still making a sizable profit.
Don't confuse compounded drugs with generic drugs. Generic drugs are copies or equivalent versions of approved drugs, and are FDA/CVM approved and inspected. Compounded drugs don't meet these requirements.
So, who takes the risk for using unapproved products? Both you and the industry are at risk. Producers take the liability for loss of animals due toxicity or to lack of efficacy. There is also the potential for regulatory action for residues or for introduction of an adulterated product into a food animal. The industry is at risk because of the perception (and the reality, if you're using them) of inappropriate drug use.
The peddlers of such products will tell you these aren't real concerns. If you agree and decide to use unapproved products, why not just post a sign in front of your operation saying: “We proudly use unapproved drugs in our cattle?” Sooner or later, food systems will be asking anyway.
Mike Apley, DVM, PhD, is an associate professor of beef production medicine at Iowa State University in Ames. W. Mark Hilton, DVM, is a clinical assistant professor of beef production medicine at Purdue University in West Lafayette, IN.