Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2220 - State Board of Pharmacy
Chapter 2 - General Rules
Section 20 CSR 2220-2.675 - Standards of Operation/Licensure for Class L Veterinary Pharmacies
Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule defines standards for a Class L veterinary pharmacy.
(1) A Class A or a Class L pharmacy permit shall be required for any entity engaged in the sale, dispensing, or filling of a legend drug for use in animals that must only be dispensed by prescription under state or federal law. For purposes of this rule, a legend drug shall be defined as provided by 21 USC section 353.
(2) Class A Pharmacies. Class A permit holders shall comply with all laws/rules applicable to Class A pharmacies, provided a Class A pharmacy shall comply with sections (7) and (8) of this rule when legend drugs are dispensed for animal use.
(3) Class L Pharmacies. A Class L pharmacy shall dispense, sell, or provide legend drugs only for animal use. Except as otherwise provided in this rule, a Class L pharmacy shall comply with all applicable state and federal pharmacy and controlled substance laws/rules including, but not limited to, all applicable provisions of Chapter 338, RSMo, and the rules of the board.
(4) Pharmacy Operations. A Class L pharmacy shall comply with 20 CSR 2220-2.010, with the following allowed modifications:
(5) A Class L pharmacy shall designate a pharmacist-in-charge as required by 20 CSR 2220-2.010(1)(M). The pharmacist-in-charge shall be responsible for supervising pharmacy operations and ensuring compliance with the provisions of this rule and all applicable state/federal laws. Except as otherwise provided in this rule, the pharmacist-in-charge shall also-
(6) A pharmacist shall not be required to be physically present on-site during the business operations of a Class L pharmacy if the pharmacist-in-charge reviews the activities and records of the pharmacy operations on a monthly basis to ensure compliance with this rule. This exemption shall not apply if the pharmacy sells, dispenses, or otherwise provides controlled substances. The date of the pharmacist-in-charge review shall be documented and maintained at the pharmacy.
(7) To be valid for purposes of dispensing, legend drug prescriptions for animal use shall conform to all requirements of sections 338.056 and 338.196, RSMo, and shall contain the following:
(8) Dispensing. A Class L pharmacy may accept, fill, enter, dispense, or otherwise provide non-controlled legend drugs for animal use in the absence of a pharmacist, provided the pharmacist-in-charge shall review the prescription record for each such prescription on a monthly basis. The review shall be documented as provided in section (6) of this rule. For purposes of 20 CSR 2220-2.010(3), the dispensing pharmacist shall be identified as the pharmacist-in-charge unless dispensed by another licensed pharmacist.
(9) Labeling. Prescriptions must be labeled as required by section 338.059, RSMo. Prescription labels may be manually written and numbered and shall include:
(10) Records. Class L pharmacy records shall be maintained as required by Chapter 338, RSMo, and the rules of the board, including, 20 CSR 2220-2.018 and 20 CSR 2220-2.080.
(11) A Class L pharmacy shall comply with all applicable state or federal controlled substance laws.
(12) The provisions of this rule shall not be applicable to the sale of medication for use in animals that may lawfully be dispensed without a prescription nor shall this rule be construed to require licensure for entities solely engaged in selling, dispensing, or providing medications authorized for dispensing without a prescription.
(13) The provisions of this rule shall not prohibit or interfere with any legally registered practitioner of veterinary medicine in the compounding, administering, prescribing, or dispensing of their own prescriptions, medicine, drug, or pharmaceutical product to be used for animals.
*Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011 ; 338.055, RSMo 1971, amended 1978, 1981, 1986, 1998, 2001, 2004, 2011; 338.056, RSMo 1978, amended 1996; 338.059, RSMo 1971, amended 1973, 1978, 1997; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011 ; 338.150, RSMo 1939, amended 1951, 1961, 1980, 1981, 2011 ; 338.196, RSMo 1991; 338.210, RSMo 1951, amended 2001, 2011 ; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2011 ; 338.240, RSMo 1951, amended 2011 ; 338.250, RSMo 1951, amended 1990, 1998; 338.280, RSMo 1951, amended 1971, 1981; and 338.343, RSMo 1989, amended 1993.