(1) The pharmacist-in-charge must be trained in the specialized functions of preparing and dispensing compounded sterile products, including the principles of aseptic technique and quality assurance. This training may be obtained through residency training programs, continuing education programs, or experience in an intravenous admixture facility.

(2) The pharmacist-in-charge shall be responsible for:

(a) the purchasing, storage, compounding, repackaging, dispensing, and distribution of all sterile products;

(b) the development and continuing review of all policies and procedures, training manuals, and quality assessment programs;

(c) providing written education material to the patient or the patient's caregiver, with respect to:

(i) drug information sheets for prescribed therapy;

(ii) compounding, admix technique, adding medications to solutions, withdrawing medications from vials, etc.;

(iii) function, operation, and troubleshooting durable medical equipment when prescribed; and

(iv) supplies and training for safe and proper handling and disposal of antineoplastic, infectious, and hazardous waste.

(d) All written education material provided to the patient or the patient's caregiver must be made a part of the patient's home care record.

(3) For each pharmacy, a pharmacist must be accessible by phone and able to dispense, if necessary, and to respond to patients' and other health professionals' questions and needs, 24 hours per day, seven days per week.

(4) The pharmacist-in-charge may be assisted by supportive personnel. These personnel must have specialized training in the field of home infusion therapy, and must work under the immediate supervision of a licensed pharmacist. The training provided to these personnel must be described in writing in a training manual. The duties and responsibilities of these personnel must be consistent with their training and experience.

(5) Pharmacy personnel shall document orientation procedures, competency assessments, and continuing education of professional and nonprofessional staff.