Current through Vol. 42, No. 1, September 16, 2024
(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.
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
