W. Va. Code R. § 15-1-12

Current through Register Vol. XLI, No. 49, December 6, 2024

Section 15-1-12 - Sterile Pharmaceutical Compounding

12.1. Permitting and Control.

12.1.1. A pharmacy compounding or mixing prescription orders for sterile solutions or suspensions shall obtain a Sterile Pharmaceutical Compounding Permit from the Board in addition to a pharmacy license. The Board shall issue a permit after a satisfactory inspection of the completed facilities.

12.1.2. The compounding and preparation of sterile prescription orders shall be accomplished in a pharmacy environment subject to the West Virginia Code and the Rules of this Board and all Federal laws and regulations.

12.1.3. Sterile compounding or mixing shall be under the supervision and control of a pharmacist who shall be present on duty during all hours of prescription preparation.

12.2. An applicant for a Sterile Pharmaceutical Compounding Permit shall provide the Board with the following:

12.2.1. A completed Board application form;

12.2.2. A copy of the Policy and Procedure Manual;

12.2.3. Statement and plans showing how the applicant meets the minimum requirements regarding space, equipment, supplies, and publications.

12.3. The compounding environment for this practice shall be separate rooms set apart from all other activities. The environment shall facilitate controlled aseptic conditions and meet all the following standards of:

12.3.1. The 2023 United States Pharmacopeia (USP) Chapter 797 Pharmaceutical Compounding - Sterile Preparations;

12.3.2 The 2023 United States Pharmacopeia (USP) Chapter 800 Hazardous Drugs; and

12.3.3. The Controlled Environment Testing Association's (CETA) Certification Guide for Sterile Compounding Facilities or a substantially similar standard for certification completed by a qualified independent certifier indicating that the compounding area is meeting its design and air quality specifications.

12.4. General Requirements.

12.4.1. Special handling and packaging shall be available to maintain stability of the prepared prescription orders during delivery to the patient.

12.4.2. All prescriptions shall include labeling, in addition to that required by other state or federal law or rule, showing:

12.4.2.a. The drug's expiration date;

12.4.2.b. The date of preparation; and

12.4.2.c. The drug's control number.

12.4.3. A pharmacy with a Sterile Pharmaceutical Compounding Permit shall provide a twenty-four (24) hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists.

12.5. Reference Works. Minimum reference works required in a pharmacy with a Sterile Pharmaceutical Compounding:

12.5.1. A current edition, in either print or electronic media, of a drug information and reference compendium such as Elsevier Gold Standard/Clinical Pharmacology, Facts & Comparisons, or other appropriate compendium approved by the board; and

12.5.2. Handbook of Injectable Drugs published by the American Society of Health System Pharmacists, or its equivalent.

W. Va. Code R. § 15-1-12