A lot of animal-health products seemed to have been in short supply or on back order in recent months, some of which is attributable to mergers and buyouts of pharmaceutical companies. While it can be frustrating for cattlemen and veterinarians when a product they trust suddenly isn’t available, even more frustrating is when unscrupulous individuals try to take advantage of these situations and manufacture drugs illegally.
The entire industry suffers a black eye when such drugs are used. It’s very important to understand the difference between pioneer, generic, compounded and pirated products.
- Pioneer products are the original products. The sponsoring pharmaceutical company has collected efficacy and safety data for approval by the Food and Drug Administration (FDA), and Good Manufacturing Practices (GMP) guidelines and legislation are used in producing the drugs.
- Generic products are copies of the pioneer product. These are approved by FDA and produced using GMP guidelines. These drugs essentially match the physiologic properties of the pioneer product, and their components provide no safety risk.
- Compounded products are legal, as long as some specific criteria are met. Legitimate pharmacy compounding is done by a licensed pharmacist when there is no other FDA-approved drug available. Strict labeling and prescription guidelines must be followed. The number of legitimate compounding situations in food animals is very limited.
- Pirated products mimic FDA-approved products but are not FDA approved. It’s impossible for drug pirates to make a product with the same purity, stability, safety, efficacy and quality of an FDA-approved product. The fact that a veterinarian or pharmacist is involved in the manufacture or distribution doesn’t guarantee the product’s quality.
In an attempt to increase their legitimacy, drug pirates often claim to be compounding pharmacists; they also may try to pass their products off as generic. If you’re buying a compounded copy of an available, approved drug, there is no way this purchase can be justified under the AMDUCA regulations and FDA compliance policy guideline for compounding.
Pirated products are commonly made from bulk drugs, usually smuggled into the U.S. They’re sold for their profit potential only; there’s little regard for the end user or the end product.
Since there’s no FDA supervision, there’s no assurance, for instance, that the compound has the chemical or the concentration it claims, or that the compound is safe for the animal. Nor is there assurance that the compound is safe for the person who consumes the meat from that animal. Plus, withdrawal times would strictly be a guess.
If it sounds too good to be true, it probably is. If, for example, you’re offered Draxxin® or Nuflor Gold® at a much lower price than is typical, a red flag should go up, especially if these products aren’t in their original bottles. It’s either stolen or it’s a pirated product.
In addition, both of these products are too new to the marketplace to have generics – another clue. But don’t be surprised to see them in what appears to be an original bottle, as some pirate operations have been known to collect empty bottles from trash cans.
In the case of antibiotics specifically, if the drug concentration is lower than what it’s supposed to be, the animal won’t receive the appropriate dosage. This will result in poor treatment success and may also increase bacterial resistance. With the interest politicians are exhibiting in regard to bacterial resistance, now isn’t the time for this to occur.
Be on the watch for this type of illegal activity and report it to your state animal health board. Don’t be tempted to put these illegal drugs into our food chain. Saving a few dollars in this manner could cost our industry billions.
Dave Sjeklocha is a feedlot consulting veterinarian at the Haskell County Animal Hospital in Sublette, KS. Contact him at 620-675-8180 or [email protected].