/ SECTION 2. Section 40-43-86(B)(4)(b) and (CC) of the 1976 Code is amended to read:
"(b) The pharmacist-in-charge shall develop and implement written policies and procedures to specify the duties to be performed by pharmacy technicians. The duties and responsibilities of these personnel
shall must be consistent with their training and experience. These policies and procedures shall, at a minimum, specify that pharmacy technicians are to be personally supervised by a licensed pharmacist who has the ability to control and who is responsible for the activities of pharmacy technicians and that pharmacy technicians are not assigned duties that may be performed only by a licensed pharmacist. One pharmacist may not supervise more than three pharmacy technicians at a time ; through June 30, 2006, at least one of these three technicians must be state-certified, and after June 30, 2006, at least two of these three technicians must be state-certified. If a pharmacist supervises only one or two pharmacy technicians, these technicians are not required to be state-certified. Pharmacy technicians do not include personnel in the prescription area performing only clerical functions, including data entry up to the point of dispensing, as defined in Section 40-43-30(14).
(CC)(1) The provisions of this subsection only apply to the compounding of medication by pharmacies permitted in the State of South Carolina.
(2) The following are the minimum current good compounding practices for the preparation of medications by pharmacists licensed in the State for dispensing or administering, or both, to humans or animals:
(a) Pharmacists engaged in the compounding of drugs shall operate in conformance with applicable laws regulating the practice of pharmacy;
(b) Based on the existence of a pharmacist/patient/practitioner relationship and the presentation of a valid prescription, or in anticipation of prescription medication orders based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient medications
that are commercially available in the market place for which the components are commercially available;
(c) Pharmacists shall receive, store, or use drug substances for compounding that meet official compendia requirements, or of a chemical grade in one of the following categories: chemically pure (CP), analytical reagent (AR), American Chemical Society (ACS), or, if other than this, drug substances that meet the accepted standard of the practice of pharmacy;
Pharmacists may compound drugs before receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/practitioner relationship, for all such products compounded at the pharmacy as required by the Board of Pharmacy A compounder shall first attempt to use components manufactured in an FDA-registered facility. When components cannot be obtained from an FDA-registered facility, a compounder shall use his professional judgment in selecting an acceptable and reliable source and shall establish purity and safety by reasonable means, to include Certificate of Analysis, manufacturer reputation, and reliability of source.
(e) For components that do not have expiration dates assigned by the manufacturer or supplier, a compounder shall label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt of the component based on the nature of the component and its degradation mechanism, the container in which it is packaged, and the storage conditions;
ef) Pharmacists may not offer compounded medications to other pharmacies for resale; however, pharmacists may compound products preparations based on an order from a practitioner for use by practitioners for patient use administration to a patient in institutional or office settings . Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services, e.g., chemicals, devices, and information, when requested; however, they may not solicit business by promoting to compound specific drug products, e.g., like a manufacturer;
fg) The compounding of legend drugs in anticipation of receiving prescriptions without a historical basis or the distribution of compounded products preparations without a patient/practitioner/pharmacist relationship is considered manufacturing.
(h) Physicians who administer compounded medications in an office or licensed ambulatory surgical facility setting shall be allowed to order and purchase those medications from the compounding pharmacy, store them in the office for future use but not for resale, and administer those medications according to their usual physician/patient/pharmacy practice relationship. A prescription for an individual patient for each administration of the drug shall not be required.
(i) Institutional pharmacies may order and store compounded preparations, both sterile and nonsterile, from compounding pharmacies in anticipation of patient orders based on the existence of a pharmacist/patient/practitioner relationship for regularly observed prescribing patterns. A chart order from a practitioner will be required for administration in a institutional facility.
(3)(a) Pharmacists engaging in compounding shall maintain proficiency through current awareness and training. Continuing education shall include training in the art and science of compounding and the rules and regulations of compounding.
(b) Pharmacy technicians may assist the pharmacist in compounding. The pharmacist is responsible for training and monitoring the pharmacy technician. The pharmacy technician's duties must be consistent with the training received. The pharmacist must perform the final check of the compound preparation to determine if the preparation is ready to dispense.
(c) Personnel engaged in the compounding of medications shall wear clean clothing appropriate to the operation being performed. Protective apparel
, such as coats, jackets, aprons, gowns, hand or arm coverings, or masks must be worn as necessary to protect personnel from chemical exposure and medication or chemical contamination.
(d) Only personnel authorized by the responsible pharmacist may be in the immediate vicinity of the drug compounding operation. A person shown at any time, either by medical examination or pharmacist determination, to have an apparent illness or open lesions that may adversely affect the safety or quality of a drug
product preparation being compounded must be excluded from direct contact with components, medication containers, closures, in-process materials, and medication products preparations until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of the products preparations being compounded. All personnel who assist the pharmacists in compounding procedures must be instructed to report to the pharmacist any health conditions that may have an adverse effect on drug products preparations.
(4)(a) Pharmacists engaging in compounding shall have
a specifically designated and an adequate area (space) for the orderly complexity level of compounding of prescriptions that is maintained in a good state of repair for the placement of material and equipment. Sterile compounding must be performed in a separate area in compliance with Section 40-43-88.
(b) Bulk medications and other chemicals or materials used in the compounding of medication must be stored in adequately labeled containers in a clean, dry, and temperature-controlled area or, if required, under proper refrigeration.
(c) Adequate lighting and ventilation must be provided in all drug compounding areas. Potable water must be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to a compounded drug
product preparation. Adequate washing facilities, easily accessible to the compounding areas of the pharmacy, must be provided. These facilities shall include, but are not limited to, hot and cold water, soap or detergent, and air-dryers or single-use towels.
(d) The area used for the compounding of drugs must be maintained in a clean and sanitary condition. It must be free of infestation by insects, rodents, and other vermin. Trash must be held and disposed of in a timely and sanitary manner. Sewage and other refuse in and from the pharmacy and immediate medication compounding areas must be disposed of in a safe and sanitary manner.
(e) If sterile
products preparations are being compounded, the pharmacist shall comply with Section 40-43-88 as applicable to the procedure.
(f) If radiopharmaceuticals are being compounded, the pharmacist shall comply with Section 40-43-87 as applicable to the procedure.
(g) If drug products with special precautions for contamination, such as penicillin or hazardous drugs, are involved in a compounding procedure, appropriate measures, including either the dedication of equipment or meticulous cleaning of contaminated equipment before its use for the preparation of other drugs, must be utilized in order to prevent cross-contamination.
(5)(a) Equipment and utensils used for compounding must be of appropriate design and capacity and stored in a manner to protect from contamination. In addition, all equipment and utensils must be cleaned and sanitized before use to prevent contamination that would alter the safety or quality of the drug
product preparation beyond that desired. The pharmacist is responsible for determining suitability for use. In the case of sterile compounding, the pharmacist shall comply with Section 40-43-88 as applicable to equipment and utensils.
(b) Automatic, mechanical, electronic, or other equipment used in compounding must be routinely inspected, calibrated, if necessary, or checked to ensure proper performance.
(c) The pharmacist shall ensure that the proper container is selected to dispense the finished compounded prescription, whether sterile or nonsterile.
(6)(a) The pharmacist shall ensure that there are formulas and logs maintained either electronically or manually. Formulas must be comprehensive and include ingredients, amounts, methodology, and equipment, if needed, and special information regarding sterile compounding.
(b) The pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate at each stage of the compounding procedure to conform to the formula being prepared. Any chemical transferred to a container from the original container must be labeled with the same information as on the original container and the date of transfer placed on the label.
(c) The pharmacist shall establish and conduct procedures so as to monitor the output of compounded prescriptions, i.e., capsule weight variation, adequacy of mixing, clarity, pH of solutions, and, where appropriate, procedures to prevent microbial contamination of medications purported to be sterile.
(7)(a) The pharmacist shall label any excess compounded
product preparation so as to reference it to the formula used and the assigned control number and the estimated beyond-use date based on the pharmacist's professional judgment, appropriate testing , or published data. In the absence of stability information applicable to the specific compound, the maximum BUD must be determined by:
(i) the type of formulation, such as nonaqueous, water containing, or topical; and
(ii) professional judgment.
product preparation must be stored appropriately.
(c) At the completion of compounding the prescription, the pharmacist shall examine the prescription for correct labeling.
(8) The pharmacist shall keep records of all compounded
products preparations for a period of time as other prescriptions as required by the Board of Pharmacy. These records must be readily available for authorized inspection during the retention period at the establishment. These records are subject to duplication by photocopying or other means of reproduction as part of the inspection.
(9) All significant procedures performed in the compounding area must be covered in written policies and procedures. These procedures must be developed for the facility, equipment, personnel, preparation, packaging, and storage of compounded preparations and ingredients to ensure accountability, accuracy, quality safety, and uniformity in compounding as appropriate for the level of compounding performed at the facility.
(10) Material Data Safety should be readily accessible from an internet website or otherwise to all personnel working with drug substances or bulk chemicals located on the compounding facility premises, and personnel should be instructed on how to retrieve needed information." /
Renumber sections to conform.
Amend title to conform.