(1) The home infusion therapy agency shall ensure that medications are delivered according to the prescribed start of therapy so that the prescription for sterile pharmaceuticals can be implemented as ordered. Once therapy has been initiated, the home infusion therapy agency shall continue to provide sterile pharmaceuticals in a timely fashion so as not to interrupt ongoing therapy.

(2) If the start of therapy is to be delayed for more than two hours from the prescribed start time, the home infusion agency shall notify both the patient and the prescribing practitioner.

(3) Patients must be notified in advance of delivery of the products. Patients must be provided with a receipt for all sterile products and supplies delivered to them.

(4) The pharmacy shall document a chain of possession for all controlled substances.

(5) The home infusion therapy agency shall ensure the environmental control of all products shipped. All compounded, sterile pharmaceuticals must be shipped or delivered to a patient in appropriate, temperature-controlled delivery containers as defined by the United States Pharmacopeia/National Formulary and stored appropriately in the patient's therapy setting.