(1) Prescription. The pharmacist, or pharmacy intern acting under the immediate supervision of a pharmacist, must receive a written or verbal prescription from an authorized prescriber before dispensing any parenteral product. Prescriptions may be filed within the pharmacy by patient-assigned consecutive numbers. A new prescription is required every twelve months or upon any prescription change. These prescriptions shall, at a minimum, contain the following:
(a) Patient name;
(b) Patient address;
(c) Drug name, strength, and dispensing quantity;
(d) Patient directions for use;
(e) Date written;
(f) Authorizing prescriber's name;
(g) Physician's address and Drug Enforcement Administration identification code, if applicable;
(h) Refill instructions, if applicable; and
(i) Provision for generic substitution.
(2) Profile or medication record system. A pharmacy-generated profile or medication record system must be separated from the oral prescription file. The patient profile or medication record system shall be maintained under the control of the pharmacist-in-charge for a period of two years after the last dispensing activity. The patient profile or medication record system shall contain, at a minimum:
(a) Patient's full name;
(b) Date of birth or age;
(c) Weight, if applicable;
(d) Sex, if applicable;
(e) Parenteral products dispensed;
(f) Date dispensed;
(g) Drug content and quantity;
(h) Patient directions;
(i) Prescription identifying number;
(j) Identification of dispensing pharmacist and preparing level A pharmacy assistant, if applicable;
(k) Other drugs patient is receiving;
(l) Known drug sensitivities and allergies to drugs and foods;
(m) Primary diagnosis, chronic conditions; and
(n) Name of manufacturer and lot numbers of components or a policy for return of recalled product if lot numbers are not recorded.
(3) Labeling. Parenteral products dispensed to patients shall be labeled with the following information with a permanent label:
(a) Name, address, and telephone number of the pharmacy;
(b) Date and prescription identifying number;
(c) Patient's full name;
(d) Name of each component, strength, and amount;
(e) Directions for use including infusion rate;
(f) Prescriber's name;
(g) Required transfer warnings;
(h) Date of compounding;
(i) Expiration date and expiration time, if applicable;
(j) Identity of pharmacist compounding and dispensing or other authorized individual;
(k) Storage requirements;
(l) Auxiliary labels, where applicable;
(m) Antineoplastic drug auxiliary labels, where applicable; and
(n) On all parenteral products, a twenty-four hour phone number where a pharmacist can be contacted.
(4) Records and reports. The pharmacist-in-charge shall maintain access to and submit, as appropriate, such records and reports as are required to ensure patient's health, safety, and welfare. Such records shall be readily available, maintained for two years, and subject to inspections by the board of pharmacy. These shall include, as a minimum, the following:
(a) Patient profile/medication record system;
(b) Policy and procedure manual;
(c) Training manuals; and
(d) Such other records and reports as may be required by law and rules of the board of pharmacy.
Information regarding individual patients shall be maintained in a manner to assure confidentiality of the patient's record. Release of this information shall be in accordance with federal and/or state laws or rules.
(5) Delivery service. There will be a provision for the timely delivery of parenteral products from a pharmacy so a practitioner's order for drug therapy can be implemented without undue delay. The pharmacist-in-charge shall assure the environmental control of all parenteral products shipped. Therefore, any parenteral products must be shipped or delivered to a patient in appropriate temperature controlled delivery containers (as defined by USP Standards) and stored appropriately in the patient's home. Chain of possession for the delivery of controlled substances via contracted courier must be documented, and a receipt required. The pharmacy, on request, will provide instruction for the destruction of unused parenteral products and supplies in the event a parenteral product is being discontinued or a patient dies.
(6) Disposal of infectious wastes. The pharmacist-in-charge is responsible for assuring that there is a system for the disposal of infectious waste pertaining to drug administration in a manner so as not to endanger the public health.
(7) Emergency kit. When parenteral products are provided to home care patients, the dispensing pharmacy may supply the registered nurse with emergency drugs if the physician has authorized the use of these drugs by a protocol for use in an emergency situation, e.g., anaphylactic shock. A protocol for the emergency kit must be submitted to and approved by the board of pharmacy.