N.M. Admin. Code § 16.19.30.10

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.30.10 - RECORDS

A. Maintenance of records. Every record required by this section shall be kept by the pharmacy for at least three (3) years.

B. Compounding records.

(1) Master Formulation records must include:

(a) provides a consistent source document for preparing the preparation (recipe);

(b) is a file of individual compounded preparations;

(c) list the name, strength, and dosage form of the preparation compounded;

(d) list all ingredients and their quantities;

(e) list equipment needed to prepare the preparation, when appropriate, and mixing instructions;

(f) other environmental controls, such as the duration of mixing and other factors pertinent to the replication of the preparation as compounded;

(g) the beyond-use date and reference source to support the assigned BUD, the container closure system(s) used in dispensing, the storage requirements, quality control procedures (e.g., pH testing, visual inspection) and expected results;

(h) physical description of the final compounded nonsterile preparation;

(i) if applicable, calculations to determine and verify quantities and/or concentrations of components and strength or activity of the API(s); and

(j) labeling requirements (e.g. shake well).

(2) Compounding records:

(a) document the name and weight or measurement of each ingredient;

(b) contain the name and strength of the compounded preparation, the formulation record reference for the preparation, the vendors or manufacturers, lot numbers, and expiration dates of the ingredients;

(c) contain information on the total quantity and number of dosage units compounded, the name of the person who prepared the preparation and the name of the pharmacist who approved the preparation;

(d) contain the date of the preparation, the assigned internal identification number or the prescription number and an assigned beyond-use date; and

(e) for all compounded preparations, results of quality control procedures are to be recorded;

(f) if applicable, calculations to determine and verify quantities and/or concentrations of components and strength or activity of the API(s);

(g) physical description of the final compounded non-sterile preparation.

N.M. Admin. Code § 16.19.30.10

16.19.30.10 NMAC - N, 09-15-06, Amended by New Mexico Register, Volume XXXV, Issue 15, August 13, 2024, eff. 8/13/2024