Okla. Admin. Code § 535:15-10-59

Current through Vol. 42, No. 7, December 16, 2024

Section 535:15-10-59 - Drug compounding controls

(a) There shall be written procedures for the compounding of drug preparations to assure that the finished preparations have the identity, strength, quality and purity they purport to have. These procedures should be available in either written form or electronically stored with printable documentation.

(b) The objective of the documentation is to allow another compounder to reproduce the identical prescription at a future date.

(c) Procedures shall include a listing of the components, their amounts (in weight or volume), the order of component mixing, and a description of the compounding process. In addition, all equipment and utensils and the container/closure system, relevant to the sterility and stability of the intended use of the drug shall be listed.

(d) These written procedures shall be followed in the execution of the compounding procedure and are designed to enable a compounder, whenever necessary, to systematically trace, evaluate, and replicate the steps included throughout the preparation process of a compounded preparation.

(e) Components shall be accurately weighed, measured, and subdivided as appropriate.

These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight and measure is correct as stated in the written compounding procedures.

(f) Written procedures shall be established and followed that describe the tests or examinations to be conducted on the product compounded (e.g., degree of variation) to ensure reasonable uniformity and integrity of compounded drug preparations. Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90% and not more than 110% of the theoretically calculated and labeled quantity of active ingredient per unit weight or volume and not less than 90% and not more than 110% of the theoretically calculated weight or volume per unit of the preparation.

(1) Such control procedures shall be established to monitor the output and to verify the performance of those compounding processes that may be responsible for causing variability in the final drug preparation. These procedures shall include, but are not limited to, the following (where appropriate):

(A) Adequacy of mixing to assure uniformity and homogeneity;

(B) Clarity, completeness or pH of solutions.

(2) The compounder shall label any excess compounded products so as to reference them to the formula used, the assigned batch number, and beyond use date based on the compounder's appropriate testing, published data, or USP-NF standard.

(g) MSDS (material data safety sheet) files should be easily accessible.

Okla. Admin. Code § 535:15-10-59

Added at 26 Ok Reg 2276, eff 7-1-09

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.