059-17 Wyo. Code R. §§ 17-10 - Master Formulation Records, Compounding Records and Labeling

(a) Sterile compounding pharmacies shall maintain a master formulation record:

(i) A master formulation record shall be maintained for CSPs prepared for more than one patient and for CSPs prepared from nonsterile ingredients;

(ii) Any changes or alterations to the master formulation record shall be approved by the designated person(s) and documents; and

(iii) The master formulations record shall include, but is not limited to, the following information:

(A) Name, strength or activity, and dosage form of the CSP;

(B) Identities and amounts of all ingredients;

(C) Type and size of container-closure system(s);

(D) Complete instructions for preparing the CSP, including equipment, supplies, a description of the compounding steps, and any special precautions;

(E) Physical description of the final CSP;

(F) BUD and storage requirements;

(G) Reference source to support the stability of the CSP;

(H) Quality control (QC) procedures; and

(I) Other information as needed to describe the compounding process and ensure repeatability.

(b) Pharmacy staff shall create a compounding record for all CSPs:

(i) The prescription, medication order, or label may serve as the compounding record;

(ii) The compounding record may be stored electronically if an ACD workflow management system, or other equipment is used to compound the CSP;

(iii) The compounding record shall be readily retrievable;

(iv) The master formulation record may serve as the basis for preparing the compounding record; and

(v) The compounding record shall include, but is not limited to, the following information:

(A) Name, strength or activity, and dosage form of the CSP;

(B) Date and time of preparation of the CSP;

(C) Assigned internal identification number;

(D) A method to identify the individuals involved in the compounding process and verifying the final CSP;

(E) Name of each component;

(F) Vendor, lot number, and expiration date for each component for CSPs prepared for more that one patient and for CSPs prepared from nonsterile ingredients(s);

(G) Weight or volume of each component;

(H) Strength or activity of each component;

(I) Total quantity compounded;

(J) Assigned BUD and storage requirements;

(K) Results of QC procedures;

(L) Master formulation record reference for the CSP, if applicable; and

(M) Calculations made to determine and verify quantities and/or concentrations of components, if applicable.

(c) The label on the immediate container of the CSP shall, at a minimum, display the following information:

(i) Assigned internal identification number;

(ii) Active ingredient(s) and their amounts, activities, or concentrations;

(iii) Storage conditions if other than controlled room temperature;

(iv) BUD;

(v) Route of administration;

(vi) Total amount or volume if it is not obvious from the container;

(vii) If it is a single dose container, a statement stating such when space permits; and

(viii) If it is a multiple dose container, a statement stating such.

Notes

059-17 Wyo. Code R. §§ 17-10

Amended, Eff. 5/13/2021.