(B) The pharmacy shall have a separate area designated for placement of the Class 100 laminar airflow hood, which must:

1. (1) be constructed so as to allow visual observation;
2. (2) not be a thruway for traffic;
3. (3) have walls, floor, ceiling, and work surfaces constructed of materials that are nonporous and do not produce particulate matter;
4. (4) be ventilated in a manner that will not interfere with the outward flow of air from the hood;
5. (5) not be used for unpacking bulk supplies;
6. (6) not be used for storage of bulk supplies and materials; and
7. (7) have an eye wash station and sink readily accessible to the area.

(C)

1. (1) All sterile pharmaceuticals must be prepared within the airflow hood work surface.
2. (2) Work surfaces of the airflow hood must be cleaned with seventy percent isopropyl alcohol or an equivalent disinfectant every eight-hour work shift and as needed for microbial, drug, and particulate matter removal. This cleaning must be documented by date, time, and initials. Documentation must be retained for two years.
3. (3) The airflow hood must be certified by a qualified technician every twelve months and must be recertified each time the hood is moved for operational efficiency in accordance with federal standards. The certification must be attached to the front of the hood and shall state the date the certification was performed. Certification documents must be retained for two years.
4. (4) The sterile product preparation area must be cleaned and disinfected weekly with appropriate agents according to written policy and procedures. This must be documented by date and initials and retained for two years.
5. (5) Prefilters must be changed in accordance with manufacturer's specifications. Changes must be documented by date and initials and documentation must be retained for two years.
6. (6) Work surfaces inside the airflow hood must be clear of drugs, records, labels, and equipment unrelated to work in process.
7. (7) All solutions, additive and nonadditive, must be checked by a pharmacist before dispensing. The checking pharmacist's initials must appear on either the prescription or medical order, the patient's profile, a compounding record, or label. Only one system must be used. Initials may be computer produced or stamped for solutions containing noncontrolled additives.
8. (8) Sterile pharmaceuticals returned by an outpatient or the outpatient's agent must be destroyed. Supplies and equipment designed by the manufacturer for one time use may not be reused. Returned sterile pharmaceuticals containing controlled substances must be destroyed in accordance with federal and state requirements.
9. (9) A sink with hot and cold running water readily accessible to the sterile products preparation area with immediate availability of germicidal skin cleanser and either a warm air blower or nonshedding single-use towels for hand drying must be available to all personnel preparing sterile pharmaceuticals.
10. (10) Adverse drug reactions sustained by patients must be documented in the patient's profile. Significant untoward reactions must be reported to the Food and Drug Administration and the manufacturer.

(D)

1. (1) Compounding shall involve aseptic manipulations that are properly and promptly executed.

2. (2) Closed system transfers must be used in compounding sterile pharmaceuticals, except for initial withdrawals from ampules.

   1. (a) All container closures shall remain intact throughout the aseptic process, except for the penetration of sterile, pyrogen-free, and particulate matter-free needles or cannulas through the designated stopper or port.
   2. (b) Ancillary devices used to facilitate the transfer, withdrawal, or delivery of sterile solutions must be sterile, free of pyrogen and particulate matter, and used in accordance with the manufacturer's labeled instructions.
3. (3) Compounded sterile pharmaceuticals must be stored immediately according to published and professional guidelines.
4. (4) Administration must be initiated in accordance with stability standards.
5. (5) If products are prepared from nonsterile ingredients, these products must be appropriately sterilized before dispensing.

(F) All sterile pharmaceuticals prepared for dispensing shall have an adhesive label affixed which shall contain the following:

1. (1) name, address, and telephone number of pharmacy for outpatients and name of facility for inpatients;
2. (2) if additive, the date solution was prepared. Nonadditive solutions must be dated if the manufacturer's protective cover is removed before dispensing;
3. (3) name of physician;
4. (4) name of patient;
5. (5) room number and bed of patient, if applicable;
6. (6) serial number of prescription or other identifying number;
7. (7) if additive solution, the name and amount of additive. If additives are identified by their generic name, the manufacturer must be identified on either the prescription, the patient's profile, or compounding record;
8. (8) name of basic solution;
9. (9) name or initials of individual preparing sterile pharmaceutical on either the prescription or medical order, the patient's profile, compounding record, or label. For solutions containing noncontrolled additives, the initials may be imprinted;
10. (10) expiration date and, if applicable, the expiration time of the solution in accordance with the manufacturer's specifications or research-supported standard of practice;
11. (11) frequency and rate of administration;
12. (12) precautionary statements, auxiliary labels, or warning labels in keeping with current standards or practice;
13. (13) special handling or storage requirements, or both;

(H) A profile or medical record must be maintained for each patient. This profile must be maintained for two years after the last dispensing activity. It shall contain at a minimum:

1. (1) patient's name, address, telephone number and, if applicable, the patient's bed or room number;
2. (2) age or date of birth, weight, height, and sex of patient;
3. (3) identity of the health care agency, if applicable;
4. (4) itemization of sterile pharmaceuticals dispensed with prescription number or other identifying number, including date dispensed and the name and amount of additives;
5. (5) drug and food allergies;
6. (6) primary diagnosis;
7. (7) prescription and nonprescription drugs and home remedies the patient is receiving; and
8. (8) documentation by a pharmacist of the resolution of other potential drug related problems.

(I)

1. (1) All cytotoxic solutions must be compounded in a Class II, biological safety cabinet. No other products may be compounded in this cabinet.
2. (2) Protective apparel must be worn by personnel compounding cytotoxic agents including gloves, closed front gowns with tight cuffs, and masks. Written procedures for handling spills of cytotoxic agents must be developed.
3. (3) There must be immediate access to emergency spill supplies wherever cytotoxic drugs are prepared.
4. (4) Prepared solutions must be identified with warning labels in accordance with state and federal requirements.
5. (5) Prepared solutions must be packaged for handling and delivery in a manner that minimizes the risk of rupture of the primary container and ensures the stability and potency of the solution.
6. (6) Documentation that personnel have been trained in the compounding, handling, and destruction of cytotoxic agents must be available. This documentation must be obtained annually.
7. (7) Documentation that personnel have been informed of the carcinogenic, mutagenic, and teratogenic nature of the cytotoxic agents handled must be available. This documentation must be updated annually by all personnel.
8. (8) Class II safety cabinets must be certified by a qualified technician every twelve months and must be recertified each time the hood is moved for operational efficiency. Earlier recertification may be required if dictated by federal or state requirements or manufacturer's specifications due to workload.

(K) A policy and procedure manual must be available in the pharmacy. The manual shall include policies and procedures as applicable for the following:

1. (1) quality control;
2. (2) sterile technique;
3. (3) destruction of returned solutions;
4. (4) labeling of injectable solutions;
5. (5) drug recall procedures;
6. (6) investigational drugs;
7. (7) handling and disposal of hazardous waste;
8. (8) cytotoxic agents;
9. (9) maintenance of patient profiles; and
10. (10) material safety data sheets.

(O) There must be a documented, ongoing, quality assurance control program that monitors patient care and pharmacy care outcomes, including but not limited to:

1. (1) routine performance of prospective drug use review and patient monitoring functions by a pharmacist;
2. (2) patient-monitoring plans that include written outcome measures and systems for routine patient assessment including, but not limited to, infection rates, rehospitalization rates, and the incidence of adverse drug reactions;
3. (3) documentation of patient training as specified in subsection (N);
4. (4) appropriate collaboration with other health care professionals.