GVMA News: Compounded Drug Preparations

Rules and Regs Update: Compounded Drug Preparations

Read: Rule 480-11-.02. 

The GVMA advocated for change in what Emergency Dispensing means in the rules of the Georgia State Board of Pharmacy.  As of May 24, 2023, “Emergency Dispensing” shall mean no more than a 10-day supply dispensed for an urgent condition to an animal patient by a licensed veterinarian with a valid veterinarian-client-patient relationship when timely access to a compounding pharmacy is not available – this is a change from the previous rule that only allowed a 96-hours supply to be dispensed. 

In the spirit of maintaining compliance with the rules of the Georgia State Board of Pharmacy here is a brief review of the rules in pharmaceutical compounding – specifically, the Pharmacist/Patient/Prescriber relationship and how that applies to you and your patients – especially when administering or emergency dispensing compounded drug preparations.

Building a relationship with your pharmacist is essential – especially in terms of pharmacists distributing compounded drug preparations to veterinarians.  Pharmacists must label all compounded preparations that are distributed to a veterinarians for administration or emergency dispensing with the following –

1. “By purchase order, Not by prescription”,
2. “For Office Use Administration or Emergency Dispensing by a Veterinarian Only – Not for resale”,
3. The name of the active ingredients and strengths contained in the compounded preparation,
4. The lot number or identification of the compounded preparation,
5. The pharmacy’s name, address and telephone number,
6. The initials of the pharmacist verifying the finished compounded preparation and the date verified,
7. The quantity, amount, size, or weight of the compounded preparation in the container,
8. An appropriate beyond-use (expiration) date of the compounded preparation as determined by the pharmacist in compliance with Board rule and USP-NF standards for pharmacy compounding, and
9. Appropriate ancillary instructions such as storage instructions or cautionary statements, and where appropriate, hazardous drug warning labels.

Pharmacists shall enter into a written agreement with a veterinarian for the veterinarian’s use and emergency dispensing of the compounded preparation before providing any compounded preparation to the veterinarian. The written agreement shall provide the following information:

1. The name and address of the veterinarian, license number and contact information.
2. An agreement by the veterinarian that the compounded preparation may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except for a case in which emergency dispensing is required.
3. An agreement by the veterinarian to include on the patient’s chart, or medication administration record the lot number and beyond-use date of the compounded preparation administered or dispensed to the patient.
4. The procedures for a patient to report an adverse reaction or to submit a complaint about a compounded preparation.
5. The procedure to be used when the pharmacy has to recall a batch of compounded preparation.

When pharmacists are compounding preparations to be provided to veterinarians for use in patient care or when pharmacists are altering or repackaging such products for veterinarians to use in patient care in the veterinarian’s office, the compounding shall be conducted as allowed by applicable federal law and Board rules and shall be in compliance with USP-NF standards for compounding.

Pharmacists may not compound Schedule II, III, IV or V controlled substances, as defined in Article 2 of Chapter 13 of Title 16 without a patient specific prescription drug order.

If you have questions about administering or emergency dispensing of compounded drug preparations send them to gvma@gvma.net.

Read the rule in full:
Ga. Comp. R. & Regs. r. 480-11-.02 Compounded Drug Preparations

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Many people were involved in achieving this change and we would like to mention Dr. Heather Lindell-Tally, Dr. Vince Obsitnik, Dr. Justin Toth and Dr. John Tarabula for their efforts that led to this rule change.