Okla. Admin. Code § 535:15-10-8

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-10-8 - Drug compounding controls

(a) There shall be written procedures for the compounding of drug preparations to assure that the finished products 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 an equivalent prescription at a future date.

(c) Documentation 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 (e.g. log, formula worksheet, original prescription, etc.) In addition, all equipment and utensils and the container/closure system, relevant to the compounding procedure 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 preparation compounded (e.g., degree of weight variation among capsules) to assure 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 validate 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) Capsule weight variation to ensure that each unit shall be not less than 90% and not more than 110% of the theoretically calculated weight for each unit;

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

(C) Clarity, completeness or pH of solutions.

(2) The compounder shall label any excess compounded preparation 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) Material safety data sheet (MSDS) files should be easily accessible.

(h)General requirements:

(1) Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available FDA-approved drug product is generally prohibited unless patient therapy is compromised.

(2) However, in special circumstances a pharmacist may compound an appropriate quantity of a drug that is different from an FDA-approved drug that is commercially available based on documentation provided by the prescribing physician of a patient's specific medical need (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available.

(A) The unavailability of such drug product must be documented prior to compounding.

(B) This or similar documentation must be available when requested by the Board.

(3) Except for those preparations where stability prohibits advanced compounding, all preparations dispensed by the pharmacy shall be in a form ready for administration, except in health care facilities where medications may be provided as demanded by policies and procedures.

(4) Compounding may be for the purpose of, or as an incident to, research, teaching, or chemical analysis.

(5) Compounding includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(6) Reconstitution of commercial products is not considered compounding for the purposes of this subchapter.

(7) Manipulation of commercial available products according to or beyond the manufacturer's instructions or copying commercial products for the reason of non-availability or component specifications would be considered compounding as pertaining to a practitioner / patient / compounder relationship.

Okla. Admin. Code § 535:15-10-8

Added at 17 Ok Reg 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff 7-1-09

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