Government

Internet and Prescription Drugs – What Is Legal in California

The CVMA continues to receive phone calls from members asking about the status of Internet, mail-order, or nonresident pharmacies, particularly since some of them have engaged in very aggressive marketing tactics aimed at clients. Clients seem to be attracted to these organizations primarily because of cost and the ease of getting prescription products. The questions most often presented to the CVMA are:

1.     Are these pharmacies operating legally?

2.     What are my obligations when I am contacted by one of these “pharmacies” requesting authorization to send my client a prescription product?

a.     Must I respond to their request?

3.     Must I give my clients a written prescription if they do not wish to purchase the product from me?

But before we get to these issues, let’s ex­plore the status of nonresident pharmacies in Cal­ifornia. Recently, the California Board of Pharmacy took the position that veterinary dangerous-drugs did not fall under its jurisdiction. This position caused a lot of confusion within California and forced the CVMA to sponsor legislation that clearly places veterinary legend/dangerous(prescription) drugs within the jurisdiction of the California Board of Pharmacy and the Veterinary Medical Board (VMB). The legislation became effective on January 1, 2004, and as of that date, all nonresident veterinary pharmacies must be in compliance with the same regulations governing human pharmacies. These requirements include being licensed in the state in which they are located and being “registered” with the California Board of Pharmacy (Section 4112, California Business & Professions Code).

And that brings us back to the questions: Are these pharmacies legal, what are my obligations, and must I provide a written prescription to my client?

Some of the nonresident pharmacies may operate within the law, at least as far as licensing and registration is concerned. But a secondary question is: Should veterinarians act as the police in this area? We suggest not. Our recommended procedure for dealing with prescriptions in general will place the burden of selecting an appropriate pharmacy on the client and not the veterinarian.

As far as your obligations when a nonresident pharmacy contacts you by fax or telephone, there are none placed upon you by law or regulation. You can decline to authorize its request for a prescription or you can elect to decline any interaction with it at all. Your obligations are to your client, not the pharmacy. You may want to consider making it hospital policy to decline to interact with pharmacies with which you choose not to have a relationship. When you get a fax or phone call, you should get the name of the client requesting the prescription product and contact them directly. Offer to provide a written prescription that they can have filled at the pharmacy of their choice. If they then elect to go back to the nonresident pharmacy in question, that will be their choice. Any problems encountered will be between the client and the pharmacy, and you will be at least one step removed.

At the same time you provide your client with the written prescription, you may also want to provide some printed information on Internet pharmacies in general. This article has links to two handouts you may want to use: Client hand-out and Buying Prescription Medicines Online: A Consumer Safety Guide.

And that brings us to the topic of written prescriptions. It has long been a CVMA (and AVMA) recommendation that you honor a client’s request for a written prescription in lieu of dispensing the product from your facility, when requested. As of January 1, 2004, this is a regulatory requirement for veterinarians, as it has been for physicians and dentists. In addition, you are required to inform your clients that they have the option of receiving a written prescription prior to dispensing prescription medications. The Veterinary Medical Board has indicated that a posted notice stating this option will fulfill this requirement. The CVMA has a plaque available with language approved by the VMB that can be ordered via our website store or by calling the CVMA office.

Now, let’s explore the definition of a valid prescription. Excerpts from Section 4040, Business and Professions Code (California Pharmacy Laws) states “prescription” means an oral, written, or electronically transmitted order. Section 2032.2 of the California Code of Regulation, Title 16 (Veterinary Practice Act), states that a written prescription shall include the following:

1.   The name, signature, address and telephone number of the prescribing veterinarian.
2.   Veterinarian’s license number and federal registry number if a controlled substance is prescribed.
3.    The name and address of the client.
4.    The species and name, number, or other identifying information for the animal.
5.    The name, strength, and quantity of the drug.
6.     Directions for use, including, if applicable, withdrawal time.
7.     Date of issue.
8.     The number of refills.

One note of caution: A properly established and maintained veterinarian-client-patient relationship (VCPR) must be in place before you can dispense prescription products or give a client a prescription — written, oral, electronic, or authorized via fax or telephone.

Section 2032.1 of the California Code of Regulations indicates that a VCPR shall exist when a California licensed veterinarian has:

1.     assumed responsibility for making judgments regarding the health of the animal

2.     discussed the course of treatment with the client and given appropriate instructions

3.     sufficient knowledge to initiate at least a general or preliminary diagnosis by virtue of an examination of the animal or by medically appropriate and timely visits to the premises where the animals are kept.

A prescription drug shall only be prescribed for a duration that is consistent with the animal patient’s medical condition or type of drug prescribed, not to exceed one year from the last examination.

In Summary:

Only a California-licensed veterinarian can write a valid prescription.

The California licensed veterinarian must have a valid and current VCPR before writing the prescription.

Prescription veterinary drugs bear the statement: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian” or something very similar.

A prescription drug shall only be prescribed for a duration that is consistent with the animal patient’s medical condition or type of drug prescribed, not to exceed one year from the last examination.

Nonresident (Internet/mail-order) pharmacies must be registered with the California Pharmacy Board.

Nonresident (Internet/mail-order) pharmacies must have a valid prescription from a California licensed veterinarian before they can send prescription products.

Practice tips:

  • Instead of interacting with nonresident pharmacies, you may want to consider giving clients a written prescription and letting the clients choose their own pharmacy. This should be a general hospital policy when dealing with all nonresident pharmacies.

Your hospital policy might read: “It is this hospital’s policy to interact only with pharmacies with which we have established a working relationship and that appear to meet generally accepted standards of quality and service. If our clients wish to deal with a pharmacy with which we choose not have a relationship, we will give them a written prescription that they can have filled at any pharmacy they choose.”

  • Client Handout:

If your client asks about nonresident pharmacies, you can give them a copy of the linked client handout. The document can be downloaded, edited to meet your needs, and printed on your letterhead. If you do not use the services of VetCentric, you will need to delete the last paragraph.

  • Refer clients to the U.S. Food and Drug Administration website for a “Consumer Safety Guide” dealing with Internet prescriptions or print out the article as a hand-out to clients.

Submit complaints to:

Please send a copy of your complaint to the CVMA and contact the CVMA if you experience illegal Internet pharmacy filling of prescriptions without your authorization.

FDA Center for Veterinary Medicine, Dr. Andrew J. Beaulieu, Associate Director for Animal Health Policy and Operations, CVM//FDA, 7519 Standish Place, Rockville, MD 20855, fax 301-827-4401, e-mail abeaulie@cvm.fda.gov

AND

California Veterinary Medical Board, 2005 Evergreen Street, Suite 2250, Sacramento, CA 95815, fax 916-263-2621, 916-263-2610 (if a pharmacy staff veterinarian prescribed Rx drug(s) without a veterinarian-client-patient relationship)

OR

California Board of Pharmacy, 400 R Street, Suite 4070, Sacramento, CA 95814, fax 916-327-6308, 916-445-5014 (if pharmacist/agent dispensed Rx drugs(s) without authorization)

If you know the state from which the Internet pharmacy operates, be sure to contact both the state pharmacy board as well as the veterinary medical board for that state.

© 2017 California Veterinary Medical Association

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