(14) “Microbiological stability” means sterility or resistance to microbial growth is retained according to specified requirements and antimicrobial agents that are present retain effectiveness within specified limits.
(15) “NF” means the National Formulary.
(16) “Physical stability” means the original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained.
(17) “Refrigerator” means a cold place in which the temperature is maintained between 36 degrees and 46 degrees Fahrenheit.
(18) “Stability” means the extent to which a compounded preparation retains, within specified limits and through its beyond use date, the same properties and characteristics that it possessed at the time of compounding.
(19) “Therapeutic stability” means the therapeutic effect remains unchanged.
(20) “Toxicological stability” means no significant increase in toxicity occurs.
(21) “USP” means the United States Pharmacopeia.
SUBCHAPTER I – General
15.10 Facilities. A pharmacist engaged in compounding shall ensure all of the following:
(1) An area designated for compounding.
(2) Orderly placement of compounding equipment, materials, and components in order to minimize the potential for compounding errors.
(3) The compounding area is maintained in a clean and sanitary condition.
(4) The compounding area is easily accessible to all of the following:
(a) Hot and cold running water, exclusive of the bathroom sink.
(b) Soap or detergent.
(c) Single-use towels.
(5) All compounding equipment, materials and components shall be stored off the floor and in a manner to prevent contamination and permit inspection and cleaning of the compounding and storage areas
15.11 Equipment and Drug Preparation Containers.
(1) A pharmacy shall possess equipment and drug preparation containers or packaging appropriate to the type of compounding performed at the pharmacy.
(2) Equipment and drug preparation containers or packaging used in compounding shall be of appropriate design and capacity, and shall be suitably stored in a manner to facilitate use, cleaning, maintenance, and protect it from contamination.
(3) Equipment and drug preparation containers or packaging used in compounding drug products shall be of suitable composition and may not be reactive, additive, adsorptive or absorptive so as to alter the stability of the compounded preparation.
(4) Equipment used in compounding shall be thoroughly cleaned and sanitized after each use, and when necessary, prior to use, according to written policies and procedures, in order to reduce bioburden and reduce the opportunity for cross-contamination.
(5) All equipment utilized in compounding preparations shall be inspected, maintained, calibrated and validated at appropriate intervals, consistent with manufacturer’s recommendations, to ensure the accuracy and reliability of equipment performance. Records shall be kept indicating the equipment was inspected, maintained, calibrated and validated.
15.12 Records of compounding. The managing pharmacist shall ensure written or electronic compounding documentation to systematically trace, evaluate, and replicate the compounding steps throughout the process of a preparation. The compounding documentation shall be maintained for a period of 5 years after the date of the last refill. The compounding documentation shall include all of the following:
(1) Official or assigned name, strength, and dosage form of the preparation.
(2) List of all APIs and added substances and their quantities.
(3) Vendor or manufacturer, lot number and expiration date of each APIs and added substances.
(4) Equipment and supplies needed to prepare the preparation.
(5) Mixing instructions pertinent to the replication of the preparation as compounded.
(6) Compatibility and stability information, including references or laboratory testing.
(7) Container or container-closure system used in dispensing.
(8) Packaging and storage requirements.
(9) Quality control procedures.
(10) Sterilization method when using non-sterile ingredients to make a sterile preparation.
(11) Total quantity compounded.
(12) Name of the person who prepared the preparation.
(13) Name of the person who performed the quality control procedures.
(14) Name of the person who approved the preparation.
(15) Date of preparation.
(16) Assigned control or prescription number.
(17) Assigned BUD.
(18) Copy of the label to dispense final product.
(19) Documentation of any adverse reactions or preparation problems reported by the patient or caregiver.
15.13 Quality control.
(1) One or more pharmacists shall complete a verification of all the following before dispensing:
(a) Written procedures were followed in the compounding process.
(b) Preparation instructions were followed.
(c) Finished preparation appears as expected.
(d) Label includes all required elements.
(e) Quality control procedures were completed.
(f) Compounding records are complete.
(2) A pharmacist shall investigate any discrepancies found during any of verifications and take appropriate corrective action before dispensing.
15.14 Training, Policies and Procedures. (1) Training. All personnel involved in the compounding, evaluation, packaging, and dispensing of compounded preparations shall be properly trained and competency is assessed for the type of compounding conducted. It is the responsibility of the managing pharmacist to ensure personnel training and competency assessments are completed and documented.
(2) Policies and procedures. The pharmacy and managing pharmacist shall establish written policies and procedures governing all of the following:
(a) Personnel qualifications and training, responsibilities, and competencies.
(b) Personal hygiene, garb, garbing, and personal protective gear.
(c) Use and maintenance of compounding facilities and equipment, including applicable certifications.
(d) Environmental monitoring.
(e) Cleaning and disinfection of compounding area.
(f) Component selection.
(g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation.
(h) Documentation requirements.
(i) Establishing BUD.
(j) Reporting of adverse drug events.
(k) A risk management program, including documentation of incidents, adverse drug reactions and product contamination.
(L) A quality assurance program.
(m) Maintaining the integrity of any classified work areas.
(n) Handling small and large spills of antineoplastic agents and other hazardous substances.
(o) Notification to patients or practioners of a preparation which is recalled.
when there is potential for patient harm.
(3) Review of policies and procedures The policy and procedures shall be reviewed at least once every 36 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the board upon request.
15.15 Labeling. The label of a compounded preparation shall include all of the following:
(2) Storage conditions if other than controlled room temperature.
(3) BUD.
(4) Special handling instructions, when applicable.
(5) Indication that the preparation is compounded unless administered by health care personnel.
15.16 Component Selection. (1) Active pharmaceutical ingredients or added substances used in compounding shall be manufactured by an FDA registered facility or accompanied by a certificate of analysis.
(2) APIs and added substances shall meet USP or NF monograph specifications when monographs are available. A pharmacist shall use professional judgement in selection of APIs if USP or NF grade is not available.
(3) All components shall be stored and handled consistent with the manufacturer’s labeling or USP or NF monographs and in a manner that prevents contamination and deterioration.
