Okla. Admin. Code § 535:15-10-3

Current through Vol. 41, No. 15, April 15, 2024

Section 535:15-10-3 - 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) All pharmacists and personnel engaging in drug compounding shall be familiar with State Board of Pharmacy regulations and should be familiar with patent regulations.

(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 Preparations from the pharmacy.

(d) The pharmacist-in-charge has the responsibility to ensure that all compounders who compound 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 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 of compounded 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, 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 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.

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

(1) Training is required for any individual who prepares compounded preparations. This training must be completed before such individual is allowed to compound 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 preparations.

(4) Testing will be conducted annually for every individual involved in compounding preparations. Compounding personnel who fail written tests shall be immediately reinstructed and reevaluated by expert compounding personnel to ensure correction of all practice deficiencies.

(5) An 'Individual Training Record' shall be maintained for every individual involved in non-sterile product preparation.

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

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

(g) All pharmacists and personnel who engage in non-sterile compounding are responsible for complying with State Board of Pharmacy regulations.

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

Okla. Admin. Code § 535:15-10-3

Added at 17 Ok Reg 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff 7-1-09; Amended at 30 Ok Reg 2012, eff 7-25-13

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