California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 10 - Dangerous Drub Distributors
Section 1780.1 - Minimum Standards for Veterinary Food-Animal Drug Retailers
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
In addition to the minimum standards required of wholesalers by section 1780, the following standards shall apply to veterinary food-animal drug retailers.
(a) Drugs dispensed by a veterinary food-animal drug retailer pursuant to a veterinarian's prescription to a veterinarian's client are for use on food-producing animals.
(b) Repackaged within the meaning of Business and Professions Code section 4041 means that a veterinary food-animal drug retailer may break down case lots of dangerous drugs as described in 4022(a), legend drugs or extra label use drugs, so long as the seals on the individual containers are not broken. Veterinary food-animal drug retailers shall not open a container and count out or measure out any quantity of a dangerous, legend or extra label use drug.
(c) Dangerous drugs, legend drugs or extra label use drugs returned to a veterinary food-animal drug retailer from a client shall be treated as damaged or outdated prescription drugs and stored in the quarantine area specified in section 1780(e)(1). Returned drugs may not be returned to stock, or dispensed, distributed or resold.
(d) A pharmacist or person issued a permit under Business and Professions Code section 4053 (hereafter called a vet retailer designated representative) may dispense drugs for use on food-producing animals on the basis of a written, electronically transmitted or oral order received from a licensed veterinarian. Only a pharmacist or the vet retailer designated representative may receive an oral order for a veterinary food-animal drug from the veterinarian. A written copy of the oral prescription shall be sent or electronically transmitted to the prescribing veterinarian within 72 hours.
(e) When a vet retailer designated representative dispenses a prescription for controlled substances, the labels of the containers shall be countersigned by the prescribing veterinarian before being provided to the client.
(f) Whenever a vet retailer designated representative dispenses to the same client for use on the same production class of food-animals, dangerous drugs, legend drugs or extra label use drugs prescribed by multiple veterinarians, the vet retailer designated representative shall contact the prescribing veterinarians for authorization before dispensing any drugs.
(g) Refilling a veterinarian's prescription
(h) Labels affixed to a veterinary food-animal drug dispensed pursuant to Business and Professions Code section 4041 shall contain the:
(i) A record of shipment or an expanded invoice shall be included in the client's shipment, and shall include the names of the drugs, quantity shipped, manufacturer's name and lot number, date of shipment and the name of the pharmacist or vet retailer designated representative who is responsible for the distribution. Copies of the records shall be distributed to the prescribing veterinarian and retained by the veterinary food-animal drug retailer for three years.
(j) If a retailer is unable at any one time to fill the full quantity of drugs prescribed, the retailer may partially ship a portion so long as the full quantity is shipped within 30 days. When partially filling a veterinarian's prescription, a pharmacist or vet retailer designated representative must note on the written prescription for each date the drugs are shipped: the quantity shipped, the date shipped, and number of containers shipped, and if multiple containers are dispensed at one time, each container must be sequentially numbered (e.g., 1 of 6 containers), If a retailer is unable to dispense the full quantity prescribed within 30 days, a new veterinarian's prescription is required to dispense the remainder of the drugs originally prescribed.
(k) Upon delivery of the drugs, the supplier or his or her agent shall obtain the signature of the client or the client's agent on the invoice with notations of any discrepancies, corrections or damage.
(l) If a person, on the basis of whose qualifications a certificate of exemption has been granted under Business and Professions Code Section 4053 (the vet retailer designated representative), leaves the employ of a veterinary food-animal drug retailer, the retailer shall immediately return the certificate of exemption to the board.
(m) Training of Vet Retailer Designated representative:
1. New section
filed 12-12-96; operative 1-11-97 (Register 96, No. 50).
2.
Amendment of subsections b., d., h., l., m.(1) and m.(2), new subsection
m.(2)(C), and amendment of NOTE filed 5-1-97; operative 5-31-97 (Register 97,
No. 18).
3. Change without regulatory effect amending section filed
12-18-2007 pursuant to section
100, title 1, California Code of
Regulations (Register 2007, No. 51).
Note: Authority cited: Sections 4005 and 4197, Business and Professions Code. Reference: Sections 4040, 4041, 4053, 4059, 4063, 4070, 4081, 4196, 4197, 4198 and 4199, Business and Professions Code.