| (B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and (C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices. (42) Segregated Compounding Area--A designated space, either a demarcated area or room, that is restricted to preparing low-risk level compounded sterile preparations with 12-hour or less beyond-use date. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of compounded sterile preparations and shall be void of activities and materials that are extraneous to sterile compounding. (43) Single-dose container--A container intended for a single use, other than single-dose vials and single-dose large volume potential solutions. Examples of single-dose containers include pre-filled syringes, cartridges, and fusion-sealed containers without preservatives. (44) Single-dose vial--A vial intended for a single use. Exceptions to this definition would be single dose vials routinely used to compound total potential nutrition (TPN) preparations (e.g., sodium chloride, sodium acetate, sodium phosphate, potassium chloride, potassium acetate, potassium phosphate, calcium glucontae, magnesium sulfate, multivitamin for injection, multi-trace elements, ascorbic acid, folic acid, heparin, phytonadione, l-carnitine, cysteine, selenium, injectable zinc). (45) Single-dose large volume parenteral solution--Large volume parenteral solutions (i.e., containers of solution of at least 1000 mL) routinely used for compounding sterile TPN preparations or for batch compounding (e.g., sterile water for injection (SWFI); 5%, 10%, and 70% dextrose in SWFI; 0.9% sodium chloride; 0.45% sodium chloride; 5% dextrose/0.9% sodium chloride; 5% dextrose/0.45% sodium chloride). (46) SOPs--Standard operating procedures. (47) Terminal Sterilization--The application of a lethal process, e.g., steam under pressure or autoclaving, to sealed final preparation containers for the purpose of achieving a predetermined sterility assurance level of usually less than 106, i.e., or a probability of less than one in one million of a non-sterile unit. (48) Unidirectional Flow--An airflow moving in a single direction in a robust and uniform manner and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area. (49) USP/NF--The current edition of the United States Pharmacopeia/National Formulary. (c) Personnel. (1) Pharmacist-in-charge. (A) General. The pharmacy shall have a pharmacist-in-charge in compliance with the specific license classification of the pharmacy. (B) Responsibilities. In addition to the responsibilities for the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning the compounding of sterile preparations: (i) developing a system to ensure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile preparations within the pharmacy receive appropriate education and training and competency evaluation; (ii) determining that all personnel involved in compounding sterile preparations obtain continuing education appropriate for the type of compounding done by the personnel; (iii) supervising a system to ensure appropriate procurement of drugs and devices and storage of all pharmaceutical materials including pharmaceuticals, components used in the compounding of sterile preparations, and drug delivery devices; (iv) ensuring that the equipment used in compounding is properly maintained; (v) developing a system for the disposal and distribution of drugs from the pharmacy; (vi) developing a system for bulk compounding or batch preparation of drugs; (vii) developing a system for the compounding, sterility assurance, quality assurance, and quality control of sterile preparations; and (viii) if applicable, ensuring that the pharmacy has a system to dispose of hazardous waste in a manner so as not to endanger the public health. (2) Pharmacists. Special requirements for compounding sterile preparations. (A) All pharmacists engaged in compounding sterile preparations shall: (i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and (ii) obtain continuing education appropriate for the type of compounding done by the pharmacist. (B) A pharmacist shall inspect and approve all components, drug preparation containers, closures, labeling, and any other materials involved in the compounding process. (C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process. (D) A pharmacist is responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process. (E) A pharmacist shall be accessible at all times to respond to patients' and other health professionals' questions and needs. Such access may be through a telephone or pager which is answered 24 hours a day. (3) Pharmacy technicians and pharmacy technician trainees. Pharmacy technicians and pharmacy technician trainees may compound sterile preparations provided the pharmacy technicians and/or pharmacy technician trainees: (A) have completed the education and training specified in paragraph (4) of this subsection; and (B) are supervised by a pharmacist who has completed the training specified in paragraph (4) of this subsection, conducts in-process and final checks, and affixes his or her initials to the appropriate quality control records. (4) Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile preparations. (A) General. (i) All pharmacy personnel preparing sterile preparations shall receive didactic and experiential training and competency evaluation through demonstration, testing (written and practical) as outlined by the pharmacist-in-charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas: (I) aseptic technique; (II) critical area contamination factors; (III) environmental monitoring; (IV) structure and engineering controls related to facilities; (V) equipment and supplies; (VI) sterile preparation calculations and terminology; (VII) sterile preparation compounding documentation; (VIII) quality assurance procedures; (IX) aseptic preparation procedures including proper gowning and gloving technique; (X) handling of cytotoxic and hazardous drugs, if applicable; and (XI) general conduct in the controlled area. (ii) The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile preparations shall be observed and evaluated as satisfactory through written and practical tests, and media-fill challenge testing, and such evaluation documented. (iii) Although media-fill tests may be incorporated into the experiential portion of a training program, media-fill tests must be conducted at each pharmacy where an individual compounds sterile preparations. No preparation intended for patient use shall be compounded by an individual until the on-site media-fill tests test indicates that the individual can competently perform aseptic procedures, except that a pharmacist may temporarily compound sterile preparations and supervise pharmacy technicians compounding sterile preparations without media-fill tests provided the pharmacist: (I) has completed a recognized course in an accredited college of pharmacy or a course sponsored by an ACPE accredited provider which provides 20 hours of instruction and experience in the areas listed in this subparagraph; and (II) completes the on-site media-fill tests within seven days of commencing work at the pharmacy. (iv) Media-fill tests procedures for assessing the preparation of specific types of sterile preparations shall be representative of all types of manipulations, products, risk levels, and batch sizes that personnel preparing that type of sterile preparation are likely to encounter. (v) The pharmacist-in-charge shall ensure continuing competency of pharmacy personnel through in-service education, training, and media-fill tests to supplement initial training. Personnel competency shall be evaluated: (I) during orientation and training prior to the regular performance of those tasks; (II) whenever the quality assurance program yields an unacceptable result; (III) whenever unacceptable techniques are observed; and (IV) at least on an annual basis for low- and medium-risk level compounding, and every six months for high-risk level compounding. (B) Pharmacists. (i) All pharmacists who compound sterile preparations for administration to patients or supervise pharmacy technicians and pharmacy technician trainees compounding sterile preparations shall: (I) complete through a single course, a minimum of 20 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may be obtained through: (-a-) completion of a structured on-the-job didactic and experiential training program at this pharmacy which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program; or (-b-) completion of a recognized course in an accredited college of pharmacy or a course sponsored by an ACPE accredited provider which provides 20 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. (II) possess knowledge about: (-a-) aseptic processing; (-b-) quality control and quality assurance as related to environmental, component, and finished preparation release checks and tests; (-c-) chemical, pharmaceutical, and clinical properties of drugs; (-d-) container, equipment, and closure system selection; and (-e-) sterilization techniques. (ii) The required experiential portion of the training programs specified in this subparagraph must be supervised by an individual who has already completed training as specified in subparagraph (B) or (C) of this paragraph. (C) Pharmacy technicians and pharmacy technician trainees. In addition to specific qualifications for registration, all pharmacy technicians and pharmacy technician trainees who compound sterile preparations for administration to patients shall: (i) have initial training obtained either through completion of: (I) a single course, a minimum of 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may be obtained through: (-a-) completion of a structured on-the-job didactic and experiential training program at this pharmacy which provides 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program; or (-b-) completion of a course sponsored by an ACPE accredited provider which provides 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph; or (II) a training program which is accredited by the American Society of Health-System Pharmacists. Individuals enrolled in training programs accredited by the American Society of Health-System Pharmacists may compound sterile preparations in a licensed pharmacy provided: (-a-) the compounding occurs only during times the individual is assigned to a pharmacy as a part of the experiential component of the American Society of Health-System Pharmacists training program; (-b-) the individual is under the direct supervision of and responsible to a pharmacist who has completed training as specified in subparagraph (B) of this paragraph; and (-c-) the supervising pharmacist conducts in-process and final checks. (ii) acquire the required experiential portion of the training programs specified in this subparagraph under the supervision of an individual who has already completed training as specified in subparagraph (B) or (C) of this paragraph. Cont'd... |
