The legal status of compounding, particularly in Arizona, has come into sharper focus of late with the never ending stream of pharmaceutical products going on back order which has left compounding pharmacies as the only source for several medications.

After numerous articles appeared in the AZVMA’s magazine regarding the legal status of compounding multiple people asked for my input and so I decided to reach out and do a little digging. Because I did not explicitly state that I would be writing about this situation when I talked with various people, I have decided not to quote anyone. Therefore this post is purely my opinion as to the current state of regulations in the State of Arizona and how they are interpreted by the various boards and agencies. Some of these issues may well transfer to other states, but regardless I would urge anyone with an interest in this subject to contact the agencies most directly responsible – including the agencies in Arizona (in your State or Providence you may find that not only are you under the State VMA practice act but also must follow the Pharmacy board Practice Act – which is the situation in AZ). I have no great expertese in this area at all other than an interest in the subject. From my personal experience and that of the friends and colleagues who helped collate this information for this blog post all the various agencies and players has been very open and honest about the current state of play in Arizona regaurding compounding.

What is Compounding?

This is a surprisingly complicated questions to answer. In essence, compounding is the act of changing the nature of a FDA approved pharmaceutical product. Adding a flavoring to a medication, crushing a tablet and combining it with a liquid medication, and obviously creating a medication from a set of ingredients are all examples of compounding. Interestingly, taking a liquid inject-able medication and dispensing that medication for use orally is also considered compounding as the method of FDA Approved administration is being changed.

So what is the difference between compounding and “off label use?”

It is my understanding that “off label” essentially means using a product in a way that is consistent with the labeling of that product but is not explicitly defined. For example, using an inject-able medication that is licensed for dogs as an inject-able medication for a cat would be an example of off label use. However, taking that same inject-able medication for dogs and using it as an oral medication for a cat would be an example of compounding.

It should also be noted that the “off label” use of medications carries considerable risk to the prescribing veterinarian and it is always recommended to get the owners express consent and be sure to check the latest literature about using any product in this way.

Can a Veterinary Hospital Compound for its own internal Use?

Technically no. Only a pharmacy can compound, but it does seem that the major issue for the Pharmacy board and the State Veterinary board is the dispensing and re-dispensing, of compounded medications.

What is the legal issue with dispensing compounded medications?

TITLE 4. PROFESSIONS AND OCCUPATIONS

CHAPTER 23. BOARD OF PHARMACY

 

Supp. 11-4

 

Authority: A.R.S. § 32-1904 et seq.

ARTICLE 1. ADMINISTRATION

Section

 

Neither the pharmacy permittee nor a pharmacist employed by the pharmacy permittee provides a compounded pharmaceutical product to a pharmacy, medical practitioner, or other person for dispensing or distributing except that a compounded pharmaceutical product may be provided to a medical practitioner to administer to a patient of the medical practitioner if each container is accompanied by the written list required in subsection (I)(5) and has a label that includes the following:

a. The pharmacy’s name, address, and telephone number;

b. The pharmaceutical product’s name and the information required in subsection (I)(4);

c. A lot or control number;

d. A beyond-use-date based upon the pharmacist’s professional judgment, but not more than the maximum guidelines recommended in the Pharmacy Compounding Practices chapter of the official compendium unless there is published or unpublished stability test data that shows a longer period is appropriate;

e. The statement “Not For Dispensing;” and

f. The statement “For Office or Hospital Administration Only.”

The upshot of above article is that medical practitioners, such as veterinarians, in the state of Arizona cannot purchase a medication from a compounding pharmacy and then repackage it for sale – dispensing in other words. A compounded medication can be bought and used internally but if a patient needs compounded medications to go home they need to be dispensed directly by the compounding pharmacy.

What does the Future Hold?

The re-dispensing of compounded medications by medical practitioners, according to the Arizona Pharmacy Board, will never be allowed. However, veterinarians being able to compound medications themselves and then dispense them to their clients does have a brighter future.

The AZVMA are planning to submit legislation to ask for a compounding exemption for veterinarians. However, this legislation has not been written and its passage is by no means guaranteed. It is also worth noting that if an exception for veterinarians is passed there will be significant regulations that practitioners will have to comply with to allow for the creation of compounded medications. There are also potentially areas where Federal law will trump State law with regards to compounding.

So Where does this Leave Us?

I have been informed by several reliable sources that both the pharmacy board and the veterinary medical board are not currently actively seeking out compounding cases to find veterinarians in violation. There is an understanding that compounding should be a tool available to Arizona veterinarians and it is considered a significant priority to have the law changed. However, it should be understood that should issues arise it is against the law and is potentially a source of liability.

The re-dispensing of compounded medications, however, is a black and white issue. Patients who need a compounded medication must have it dispensed by the compounding pharmacy.

This post is only meant as a starting point for your own research on the subject, and as a primer as far as the various issues.

As usual, comments, questions, and general abuse are always welcome.

Advertisements