Compounded medications: Legal and ethical considerations

Last year Riley was on the "miracle" antibiotic chloramphenicol, which had to be ordered from a compounding pharmacy. After the polo pony tragedy I wasn't thrilled to go this route. I placed four separate orders, and noticed distinct differences between batches in color and consistency. Some doses were running and others were so thick it was hard to administer -- and the differences could not be attributed to temperature.  

Recently Equine Disease Quarterly published a short article "Legal and ethical Veterinary compounding." Read the whole article but here are some key points...

• Pharmacies specializing in veterinary compounding have been growing exponentially, aided by the ability to reach a larger number of consumers via the Internet. 
• Compounded drugs are not the same as generic drugs. Generic drugs are FDA approved and must have bioequivalence to the “pioneer brand name” drug. Compounded drugs are spontaneously prepared products that lack FDA approval.
• Compounded drugs with their possible inadequacies are better than no drug at all and suitable for a small patient population. 
• Equine practitioners using compounded products are put in a position of evaluating the integrity of the compounding pharmacy as well as the quality and consistency of the pharmaceuticals they produce. 
• The FDA does not routinely inspect compounding pharmacies. This lack of regulatory oversight means that almost none of the veterinary compounding pharmacies follow Good Manufacturing Practices (GMPs) guidelines. GMP training and protocol are not required of compounding pharmacies because they are not authorized to “manufacture” drug products. 
• Negligent compounders prepare products from unregulated raw materials with no quality standards. Many of these raw materials are chemical grade bulk products that were never intended for use in the preparation of legitimate pharmaceuticals. 
• Other compounding pharmacies distribute medication without a valid prescription. Veterinarians are schooled on quality patient care, but few pharmacists receive training in quality control for pharmaceutical production.

Veterinarians who frequently use compounded products would be well advised to learn more about pharmacy issues related to veterinary medical therapy. For example:

• It is illegal to compound a specific product when there is an approved drug form of that specific product, except to make a different dosing form. However, the approved product must be used to make the compounded new dose form.
• It is illegal to mark up prices on compounded drugs.
• As a veterinarian, if you use a compounded product, you assume liability for any adverse effects or efficacy failure.
• Drug manufacturers are required to carry product liability insurance; pharmacies are not.
• It is illegal to have a drug compounded in order to obtain the drug at a lower price.

How to pick a compounding pharmacy

Well, I tried to do some reading on this subject, and very quickly one gets into quality assurance procedures that are rather technical and detailed.  I have compiled a resource list below (for those of you who want to get into more detail). 

RESOURCES

List of pharmacies accredited by the Pharmacy Compounding Accreditation Board

Find a pharmacist from the International Academy of Compounding Pharmacists

How to evaluate a compounding pharmacy from The Compounder

Legal and ethical veterinary compounding from The Horse magazine

Quality assurance issues in compounding pharmacy from imjournal.com

AVMA policy regarding compounding from AVMA

The misuse of compounding by pharmacists from quackwatch.org