Arizona Veterinary Board Compounding Answers

The Arizona Veterinary Medical  Examining Board Scratching Post Newsletter dated February 2012 contained the following questions and answers regarding compounding:

This was submitted by an attorney that presented this Information to the Board at their December 21, 2011

meeting. The Board has not adopted policies to address or enforce these interpretations.

Q: Why are some pharmacies willing to sell bulk compounds for veterinary hospital dispensing and others are

not?

A:  The pharmacists may not be aware that the clinic is dispensing the medications for clients to take home, or the pharmacy may be unfamiliar with the laws governing this practice.

Q: What If I am not reselling the compounded medication, rather I am providing the take-home portion of a compounded medication that was  obtained from a pharmacy free of charge?

A: Both reselling and dispensing at no-fee are restricted to the practice of pharmacy in Arizona.

Q: Does this mean that veterinarians must write a prescription for 100% of the compounded medications

used to treat animals outside of the clinic?

A:  Yes

Q: Does this mean that veterinarians are restricted from sending a small quantity of compounded medications home with the patient to cover the period of time between the patient’s visit and the

pharmacy’s filling of the prescription?

A: Yes

Q: What if my practice works exclusively with rescued animals that are under foster care, can a pharmacy

provide my practice with pro-made compounded medications to send to the foster homes?

A: No. Even fostered animals cared for outside of the clinic or hospital require the veterinarian to arrange for a pharmacy to fill the prescription.

Q: What If there is an acute  need for a compounded medication and the animal cannot wait?

A: Most specialty pharmacies that provide compounding services understand these challenges and provide emergency services. The specialty pharmacies can also arrange for delivery of medications to rural areas, usually within 24 hours. Collaborating with a trained veterinary pharmacy specialist can often provide

the veterinarian with several options during emergency situations to accommodate acute needs.

Q: Can the State of Arizona update the veterinary practice act to address this issue?

A: The legislature does a have process and the power to expand the veterinary practice to show veterinarians more options as they pertain to compounding services.

 

COMPOUNDED MEDICATIONS

FREQUENTLY ASKED QUESTIONS

Submitted by Roger Morris

Source is found here

Arizona's Veterinary Administrative Rules Regarding Drug Dispensing

Arizona's Veterinary Administrative Rules, which should be read in conjunction with the statutes discussed in the previous blog, relating to drug dispensing have a requiring that the veterinarian notify the animal owner that some prescription-only drugs and controlled substances may be available at a pharmacy.

ARTICLE 8. DRUG DISPENSING
R3-11-801. Notification that Prescription-only Drugs or Controlled Substances May Be
Available at a Pharmacy
A.  A dispensing veterinarian shall notify an animal owner that some prescription-only drugs and 
     controlled substances may be available at a pharmacy by:
     1.  Stating the availability at or before the time of dispensing;
     2.  Posting a written statement that is visible to the animal owner; or
     3.  Providing the animal owner with written notification.
B.   A dispensing veterinarian may provide a written prescription to the animal owner if requested by
an animal owner.
R3-11-802. Labeling Requirements
A veterinarian shall dispense a prescription-only drug or a controlled substance in a container
bearing a legible label that sets forth all of the information in A.R.S. § 32-2281(A)(1), and the name
and telephone number of the veterinary medical premises from which the prescription-only drug or
controlled substance is dispensed.
R3-11-803. Packaging Requirements
A.   A veterinarian shall dispense four ounces or less of a prescription-only drug in a childproof
container unless the animal owner waives this requirement.
B.   A veterinarian shall dispense a controlled substance in a childproof container.  
C.   A veterinarian may dispense more than four ounces of a bulk prescription-only drug in a nonchildproof container.
D.   A veterinarian may dispense a prescription-only drug in the manufacturer's original dispensing
package without repackaging the prescription-only drug in a childproof container.
R3-11-804. Reserved 28
R3-11-805. Storage
A.   A dispensing veterinarian shall store controlled substances under lock and key except for
controlled substances that are authorized by a responsible veterinarian to be administered by
personnel.
B.   A dispensing veterinarian shall store prescription-only drugs in an area to which members of the
public are not allowed access unless accompanied by a veterinarian or a member of the
veterinarian's staff.
C.   A dispensing veterinarian shall store prescription-only drugs and prescription-only devices in
compliance with state and federal laws and in compliance with the manufacturer's requirements.
R3-11-806. Reserved
R3-11-807. Dispensing a Controlled Substance or Prescription-only Drug
A.   When dispensing a controlled substance:
1.  A dispensing veterinarian or personnel who are not veterinarians but who
     are authorized by a veterinarian may:
           a. Select the controlled substance,
           b. Count the quantity of the controlled substance, and       
           c. Place the controlled substance in a prescription container.
         2.  Licensed or unlicensed personnel may:
           a. Prepare labels,
           b. Prepare drug containers for controlled substances, or          
            c. Record information required by state and federal laws.
3.   A dispensing veterinarian shall review the label of a repackaged controlled substance and
the patient's medical record and ensure that the label complies with R3-11-502 and state and
federal laws before the controlled substance is dispensed.
B.   When dispensing a prescription-only drug:
1.   A dispensing veterinarian or personnel who are not veterinarians but who are                          
authorized by a veterinarian may:
            a. Repackage prescription-only drugs,     
            b. Prepare labels,            
            c. Prepare containers for prescription-only drugs, or   
            d. Record information required by state or federal laws.
      2.  The dispensing veterinarian authorizing the dispensing shall ensure that records are 
maintained according to R3-11-502(K) and R3-11-502(L) and all state and federal laws are
followed.

These statutes can be found here.

Arizona's Veterinary Medical Examining Board Statute Regarding Dispensing of Drugs and Devices

Arizona's veterinary statute regarding dispensing of drugs and devices provides:

Article 7  Dispensing of drugs and devices
32-2281. Dispensing of drugs and devices; conditions; definition
A. A veterinarian may dispense drugs and devices kept by the veterinarian if:
 1. All prescription-only drugs are dispensed in packages labeled with the following
information:
  (a) The dispensing veterinarian's name, address and telephone number.
  (b) The date the drug is dispensed.
  (c) The animal owner's name and the animal's or herd's identification.
  (d) The name, strength and quantity of the drug, directions for its use and any
        cautionary statements.
  2. The dispensing veterinarian enters into the medical record the name, strength and
quantity of the drug dispensed, the date the drug is dispensed and the therapeutic
reason.
B. The Board shall adopt rules providing that the animal's owner or the person responsible
for the animal shall be notified that some prescription-only drugs may be available at a
pharmacy and a written prescription may be provided to the animal's owner or the person
responsible for the animal if requested.
C. A veterinarian shall dispense only to the animal's owner or person responsible for the
animal he is treating and only for conditions being treated by that veterinarian.  The
veterinarian shall supervise the dispensing process.  In this subsection, "supervision" means
that a veterinarian makes the determination as to the legitimacy or the advisability of the drugs
or devices to be dispensed.
D. This section shall be enforced by the Board which shall establish rules regarding access
to, labeling, record keeping, storage and packaging of drugs that are consistent with the
requirements of chapter 18 of this title.  The Board may conduct periodic inspections of
dispensing practices to assure compliance with this section and applicable rules.
E. For the purposes of this section, "dispense" means the delivery by a veterinarian of a
prescription-only drug or device to an animal, an animal's owner or the person responsible for
an animal and includes the prescribing, administering, packaging, labeling and security
necessary to prepare and safeguard the drug or device for delivery.

The statute can be found here.