Price is not justification for Using a Compounded Product

An article in Veterinary Practice News written by Lou Anne Epperley, DVM appearing here discusses why price is not a justification for using compounded products.

That articles states in part: 

No wonder some veterinarians want to believe there’s a cheaper way to achieve the desired result promised by federal Food and Drug Administration-approved veterinary drugs.

For any given scenario, you might luck out with a compounded home remedy. But there’s a substantial case to be made for advocating the treatments bearing the government label.

“What’s happening in our profession is that veterinarians are compounding as a way to get a cheaper product,” said Dawn Merton Boothe, DVM, MS, Ph.D., professor and director of clinical pharmacology at Auburn University in Alabama. “Veterinarians are legally empowered to use drugs extra-label and compounded drugs as well. But that does not absolve them from civil liability. Cost is not a justification for using a compounded product.”

Compounding doesn’t have to be a dirty word. The FDA Extra-label Drug Use regulations define compounding as a “customized manipulation” of an approved drug or drugs by a veterinarian or pharmacist to meet the needs of a particular patient. When you mix two injectable drugs, make a paste or suspension from crushed tablets, or add flavoring, you’re legally compounding. It is illegal, however, to mix homemade drugs from bulk or raw active ingredients.

“Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug,” says a brochure published jointly by the Animal Health Institute, the American Veterinary Medical Association and the American Veterinary Distributors Association.

Questions to ask include:

"Practitioners should ensure that the pharmacy they are using is, first, licensed in its respective state and, second, has quality standards in place to satisfy your exacting standards,” Sheehan said. “To that end, we encourage practitioners to ask those hard questions. To know the country of origin for bulk powders is not nearly as meaningful as knowing what that pharmacy does with that powder to ensure its potency. Ask about the pharmacy’s quality program before you align with them.”

Two Key Things Regarding Compounding: Follow the Applicable State Law and Price Should Not Be A Factor

An article written by Scott Karolchyk, MS, RPh, FIACP, entitled Pharmaceticual Compounding, The Right and Responsibility fo Pharmacists to Compound , appearing in the American Journal of Mesotherapy can be read by clicking here.  Karolchyk makes two very good points: 

1.  follow the applicable state law relating to pharmacy and compounding and

2. price is not a factor; and advertisements or marketing promoting the price of compounded preparations should not be used.  If price is advertised, the FDA may view that the company is a manufacturer or wholesaler.

Here is Karolchyk's entire list of factors to remember:

The Responsibilities of Pharmacists to the Profession Patients, and Colleague

1. Operate in conformance with applicable state law regulating the practice of pharmacy

2. Ensure that your professional conduct is above reproach.

3. Practice the art and skill of compounding pharmacy to the best of your ability.

4. Know the limits of your expertise and refer to colleague on issues beyond your knowledge and skill.

5. Continue self-education to improve your standard of compounding practice.

6. When possible, accept responsibility to advance the profession of pharmacy and the practice of compounding by participating in properly developed programs,research projects, seminars, teaching opportunities, lectures, and publications.

7. When possible, accept responsibility to advance the profession of pharmacy and practice of compounding by taking leadership positions with the state association, licensing authority, college of pharmacy, national pharmacy organization, or other organizations that have as their objective the betterment of the profession of pharmacy.

8. Willingly accept responsibility to advance the professionof pharmacy and the practice of compounding by representing to lawmakers at the state and national level the policies and agendas that have as their objective the betterment of the profession of pharmacy.

9. Ensure that marketing practices, fee structures, and overall promotion of your practice are implemented in the best interest of the profession and the treatment of patients.

10. Share ideas and information with colleagues and assist them in their professional development.

11. Give credit to the contributions of your colleagues.

12. Be responsible when placing an appropriate value on your services, and consider the time, skill, experience, and any special circumstances involved in the performance of that service when determining any fee.

13. Do not deny services on the basis of race, religion, gender, disability, age, or national origin.

14. Do not dispense medications to a third entity for resale.

15. Uphold the triad relationship of patient, physician, and pharmacist as the basis for pharmacy practice.

16. Know the details of and adhere to the National Association of Boards of Pharmacy Good Compounding Practices Applicable to State-Licensed Pharmacies or other international standards.

17. Do not engage in marketing or promotional practices that:

       a. Utilize manufacturers’ names or the names of patented products

       b. Create misinformation with claims of therapeutic equivalence

       c. Create misinformation by perception that compounded products are generic products

       d. Base such promotion and advertising solely on price