Okla. Admin. Code § 535:15-10-52

Current through Vol. 42, No. 8, January 2, 2025

Section 535:15-10-52 - Pharmacist responsibilities

(a) All Pharmacists who engage in drug compounding, shall be proficient in compounding and should continually expand their compounding knowledge by participating in seminars and/or studying appropriate literature.

(b) Every pharmacist engaging in drug compounding must be familiar with all details of USP Compounding Standards.

(c) The pharmacist has the responsibility to:

(1) Ensure the validity of all prescriptions

(2) Certify all prescriptions.

(3) Approve or reject all components, drug product containers, closures, in-process materials, and labeling.

(4) Ensure preparations are of acceptable strength, quality, and purity.

(5) Verify all critical processes to ensure that procedures will consistently result in the expected qualities in the finished preparation.

(6) Prepare and review all compounding records to ensure that no errors have occurred in the compounding process.

(7) Ensure appropriate stability evaluation is performed or determined from the literature for establishing reliable beyond-use dating.

(8) Ensure the proper maintenance, cleanliness, and use of all equipment used in a prescription compounding practice; and,

(9) Ensure only authorized personnel shall be in the immediate vicinity of the drug compounding operation.

(10) Perform final check of preparations prior to their release from the pharmacy.

(A) A check for compounding accuracy must ensure accuracy of the label and volumes or quantities of all drugs and solutions

(B) A visual examination procedure must ensure:

(i) Comparison with original order for initial dispensing;

(ii) Accuracy of calculations;

(iii) Use of proper solutions, additives and equipment;

(iv) Labels are complete;

(v) Proper assignment of beyond use date and time;

(vi) The integrity of the container, including checking for visual defects;

(vii) Proper storage; and,

(viii) Absence of particulate matter, precipitates, turbidity, discoloration, evidence of contamination or other signs that the preparation should not be used.

(C) The pharmacist shall reject and destroy all preparations that do not pass the final examination.

(D) Pharmacists shall document final preparation examinations prior to releasing the Compounded Sterile Preparations from the pharmacy.

(d) The pharmacist-in-charge has the responsibility to ensure that all compounders who compound sterile pharmaceuticals meet all requirements for training, testing and education set forth in Board regulations at least annually.

(1) Competency shall be demonstrated prior to preparing any sterile products for patient use, and

(2) Whenever the quality assurance program yields unacceptable results the compounder shall be immediately reinstructed and reevaluated, and

(3) Whenever unacceptable or questionable techniques are observed the compounder shall be immediately reinstructed and reevaluated.

(e) Pharmacist requirements. Any pharmacist in charge who performs or supervises the preparation or sterilization of sterile medications shall:

(1) Have available written policies and procedures for all steps in the compounding of preparations. In addition, said policies and procedures shall address personnel education and training and evaluation, storage and handling, clothing, personal hygiene, hand washing, aseptic technique, quality assurance, expiration dating, and other procedures as needed.

(2) Certify that all participating pharmacists, interns and technicians have completed training and testing program in sterile product preparation. Documentation of training and testing shall be available for review.

(3) Develop policies and procedures to annually test and review the techniques of participating pharmacists and pharmacy technicians to assure adherence to aseptic procedures.

(f) Staff will be trained and evaluated as follows:

(1) Training is required for any individual who compounds sterile preparations. This training must be completed before the individual is allowed to compound sterile preparations.

(2) Training may consist of any combination of didactic and experiential methods which must convey proper technique, infection control procedures, etc. required by USP standards,

(3) A written test shall be administered and passed based on the material referenced above upon initial hire or prior to assignment to compound sterile preparations.

(4) Media-fill challenge tests will be used to evaluate sterile technique.

(5) Results of the media challenge tests shall be documented and logged.

(6) End product testing that results in a failure, will result in a review of the aseptic technique of the individual involved.

(7) Testing involving media challenge tests will be conducted annually for every individual involved in sterile preparation compounding. Semiannual testing will be conducted for personnel involved in high-risk level compounding. Compounding personnel who fail written tests or whose media-fill test vials result in gross microbial colonization shall be immediately reinstructed and reevaluated by expert compounding personnel to ensure correction of all aseptic practice deficiencies.

(8) Glove fingertip sampling using processes compliant with the most current USP standards required procedures shall be used to evaluate competency of personnel in performing hand hygiene and garbing procedures initially and at least annually. Such test shall be repeated until the required number of consecutive negative culture results are obtained.

(9) An 'Individual Training Record' shall be maintained for every individual involved in sterile preparation compounding.

(10) Nothing in these regulations shall prohibit a licensed student pharmacy intern engaged in experiential classes from assisting a properly qualified pharmacist in compounding sterile preparations under that pharmacist's direct supervision.

(11) Complete documentation by a pharmacist of training and testing shall be available for inspection.

(g) All pharmacists who engage in sterile compounding are responsible for complying with all aspects of State Board of Pharmacy regulations.

(h) Pharmacy technicians and interns participating in the compounding of sterile preparations shall have completed a pharmacist supervised training and testing program in sterile compound preparation. Completed documentation by a pharmacist of training and testing shall be available for inspection

Okla. Admin. Code § 535:15-10-52

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.

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021