Home Table of Contents

§ 1780.1. Minimum Standards for Veterinary Food-Animal Drug Retailers.

16 CA ADC § 1780.1BARCLAYS OFFICIAL CALIFORNIA CODE OF REGULATIONS

Barclays Official California Code of Regulations Currentness
Title 16. Professional and Vocational Regulations
Division 17. California State Board of Pharmacy
Article 10. Wholesalers (Refs & Annos)
16 CCR § 1780.1
§ 1780.1. Minimum Standards for Veterinary Food-Animal Drug Retailers.
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extra label use drugs returned to a veterinary food-animal drug retailer from a client shall be treated as damaged or outdated prescription drugs and stored in the quarantine area specified in section 1780(e)(1).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
(1) A veterinary food-animal drug retailer may refill a prescription only if the initial prescription is issued indicating that a specific number of refills are authorized. If no refills are indicated on the initial prescription, no refills may be dispensed. Instead, a new prescription is needed from the veterinarian.
(2) A veterinary food-animal drug retailer may not refill a veterinarian's prescription order six months after the issuance date of the initial order. Records of any refills shall be retained by the veterinary food-animal drug retailer for three years.
(h) Labels affixed to a veterinary food-animal drug dispensed pursuant to Business and Professions Code section 4041 shall contain the:
(1) Active ingredients or the generic names(s) of the drug
(2) Manufacturer of the drug
(3) Strength of the drug dispensed
(4) Quantity of the drug dispensed
(5) Name of the client
(6) Species of food-producing animals for which the drug is prescribed
(7) Condition for which the drug is prescribed
(8) Directions for use
(9) Withdrawal time
(10) Cautionary statements, if any
(11) Name of the veterinarian prescriber
(12) Date dispensed
(13) Name and address of the veterinary food-animal drug retailer
(14) Prescription number or another means of identifying the prescription, and if an order is filled in multiple containers, a sequential numbering system to provide a means to identify multiple units if shipped to the same client from the same prescription (container 1 of 6, container 2 of 6, etc.)
(15) Manufacturer's expiration date
(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) A course of training that meets the requirements of section 4053(b)(4) shall include at least 240 hours of theoretical and practical instruction, provided that at least 40 hours are theoretical instruction stressing:
(A) Knowledge and understanding of the importance and obligations relative to drug use on food-animals and residue hazards to consumers.
(B) Knowledge and understanding of state and federal law regarding dispensing of drugs, including those prescribed by a veterinarian.
(C) Knowledge and understanding of prescription terminology, abbreviations, dosages and format, particularly for drugs prescribed by a veterinarian.
(D) Understanding of cautionary statements and withdrawal times.
(E) Knowledge and understanding of information contained in package inserts.
(2) As an alternative to the training program specified in paragraph (1), other training programs that satisfy the training requirements of 4053 include fulfillment of one of the following:
(A) Possessing a registration as a registered veterinary technician with the California Veterinary Medical Board.
(B) Being eligible to take the State Board of Pharmacy's pharmacist licensure exam or the Veterinary Medical Board's veterinarian licensure examination.
(C) Having worked at least 1,500 hours within the last three years at a veterinary food-animal drug retailer's premises working under the direct supervision of a vet retailer designated representative. The specific knowledge, skills and abilities listed in sections 1780.1(m)(1)(A-E) shall be learned as part of the 1500 hours of work experience. A vet retailer designated representative who vouches for the qualifying experience earned by an applicant for registration must do so under penalty of perjury.
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.
HISTORY
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).
This database is current through 9/4/20 Register 2020, No. 36
16 CCR § 1780.1, 16 CA ADC § 1780.1
End of Document© 2020 Thomson Reuters. No claim to original U.S. Government Works.