Chapter 480-21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES

Rule 480-21-.01 Definitions

For the purpose of these rules and regulations, the following definitions apply:

(a)	Retail Pharmacy Providing Home Health Care Services. A retail pharmacy providing home health care services is defined as a licensed retail pharmacy that routinely prepares and dispenses compounded, sterile parenteral products to outpatients.

(b)	Outpatient. An outpatient is defined as a patient in the home environment or an institutionalized patient that is receiving compounded, sterile parenteral products from a pharmacy outside the institution.

(c)	Compounded, Sterile Parenteral Products. Compounded, sterile parenteral products are defined as those parenteral drug products that require preparation by the pharmacist and which must be sterile, stable, and effective when dispensed for patient use.

All retail pharmacies providing home health care services must have a current retail pharmacy permit. Therefore, they must comply with all retail pharmacy laws and regulations as well as the special regulations contained in these rules.

Rule 480-21-.03 Personnel

(1)

Pharmacist-in-Charge. The pharmacist-in-charge at each retail pharmacy providing home health care services shall be knowledgeable in the specialized functions of preparing and dispensing compounded, sterile parenteral products, including the principles of aseptic technique and quality assurance. This knowledge is may be obtained through residency training programs, continuing education programs, or experience in an IV admixture facility. The pharmacist-in-charge shall be responsible for the purchasing, storage, compounding, repackaging, dispensing, and distribution of all drugs and pharmaceuticals. The pharmacist-in-charge shall also be responsible for the development and continuing review of all policies and procedures, training manuals, and the quality assurance programs. The pharmacist-in-charge may be assisted by additional pharmacists adequately trained in this area of practice.

(2)

Supportive Personnel. The pharmacist-in-charge may be assisted by supportive personnel. These personnel shall have specialized training in this field, and shall work under the direct supervision of a licensed pharmacist. The training provided to these personnel shall be described in writing in a training manual. The duties and responsibilities of these personnel must be consistent with their training and experience.

(3)	Secretarial Personnel. Secretarial and clerical support shall be provided as required to assist with record keeping and other administrative duties.

(4)	Staffing. A licensed pharmacist shall be accessible at all times at each such licensed facility to respond to patients' and other health professionals questions and needs.

Rule 480-21-.04 Physical Requirements

The physical requirements are:

(a)

Space. Each retail pharmacy providing home health care services shall have a designated area for preparing compounded, sterile parenteral products. This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. The minimum space shall be 150 square feet. It shall be used only for the preparation of specialty products. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

(b)

Equipment.

1.	Laminar Airflow Hood; or Class 100 Clean Room;

2.	Infusion Pumps, if appropriate;

3.	Sink, in working condition, with hot and cold running water, which is convenient to the compounding area for the purpose of hand scrubs prior to compounding;

4.	Equipment for light/dark field examination;

5.	Appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapy agents;

6.	A Class II, vertical flow biological safety cabinet, if chemotherapy agents are routinely prepared;

7.	Refrigerator/Freezer with a thermometer and in working condition.

(c)

Supplies.

1.	Disposable needles, syringes and other supplies needed for aseptic admixture;

2.	Disinfectant cleaning solutions;

3.	Handwashing agent with bactericidal action;

4.	Disposable, lint free paper towels;

5.	Appropriate filters and filtration equipment;

6.	Disposable masks and sterile, disposable gloves;

7.	Gowns, if chemotherapy agents are routinely prepared;

8.	An oncology drug spill kit, if chemotherapy agents are routinely prepared.

(d)	References. In addition to references required of a retail pharmacy, current edition of an established reference on IV stability and incompatibility, such as, HANDBOOK ON INJECTABLE DRUGS, or KING'S GUIDE TO PARENTERAL ADMIXTURES.

(e)

Variances.

1.

The pharmacist-in-charge may submit to the Georgia State Board of Pharmacy a written request for a variance to these provisions relating to minimum equipment requirements. Stated reasons for application for variances must be included in the submitted request. A variance shall be granted by the Board only when, in the judgement of the Board, there are sound reasons for doing so that relate to the necessary or efficient delivery of health care. After consideration by the Board, the requestor will be notified in writing of the Board's decision.

2.	If approved, said letter(s) will serve as the proof of the Board's approval for variances indicted in the letter, and must be posted next to the inspection report.

Rule 480-21-.05 Drug Distribution and Control

Regulations are:

(a)	General. A drug distribution system is the entirety of that mechanism by which a physician's prescription drug order is executed, from the time the drug is ordered and received in the pharmacy, to the time the prescribed drug is dispensed to the patient.

(b)	Purchasing. All drugs and pharmaceutical products purchased and dispensed by a retail pharmacy providing home health care services shall meet national standards of quality (USP-NF standards) and shall be clearly and accurately labeled by the manufacturer or distributor as to contents.

(c)

Policy and Procedure Manual. A policy and procedure manual shall be prepared and maintained at each retail pharmacy providing home health care services and be available for inspection by agents of the Georgia Drugs and Narcotics Agency. The policy and procedure manual shall set forth in detail the objectives and operational guidelines of the pharmacy. The manual shall be reviewed and revised at a minimum on an annual basis. A copy shall be provided to the Board of Pharmacy when applying for a permit or engaging in this specialized area of practice.

(d)

Prescription Drug Order. The pharmacist or pharmacy intern/extern acting under the direct supervision of a licensed pharmacist must receive a written or verbal prescription drug order from a physician before dispensing any compounded, sterile parenteral product or other drug. Prescriptions drug orders may be filed by patient, assigned consecutive numbers, or any other system that assures a complete, retrievable and accurate record. A new prescription drug order is required every six (6) months if the physician does not specify a course of therapy. These prescriptions drug orders shall, at a minimum, contain the following:

1.	Patient's full name;

2.	Patient address for a controlled substance;

3.	Drug name, strength, and dispensing quantity;

4.	Patient directions for use;

5.	Date of issuance;

6.	Prescriber's signature;

7.	Prescriber's address and drug enforcement administration identification code, if applicable;

8.	Refill instructions.

(e)

Patient Profile. A pharmacy generated patient profile that may be separate from the prescription file must be maintained for each patient. The patient profile 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 shall contain, at a minimum:

1.	Patient's full name;

2.

Age;

3.

Weight;

4.

Sex;

5.	Compounded, sterile parenteral products dispensed;

6.	Date dispensed;

7.	Drug content and quantity;

8.	Patient directions;

9.	Prescription serial number;

10.	Identification of dispensing pharmacist(s);

11.	Other drugs patient is receiving;

12.	Patient's drug sensitivities and allergies to drugs and foods;

13.	Primary diagnosis of the patient.

(f)

Labeling. Each compounded, sterile parenteral product dispensed to outpatients shall be labeled with the following information with a permanent, non-removable label:

1.	Name, address, and telephone number of the retail pharmacy providing home health care services;

2.	Date and identifying prescription number;

3.	Patient's full name;

4.	Name of each drug (brand or generic), strength, and amount;

5.	Directions for use to the patient, including infusion rate;

6.	Prescriber's name;

7.	Required precautionary information regarding controlled substances;

8.	Date and time of compounding;

9.	Expiration date and expiration time of the product; and

10.	Identity of pharmacist compounding and dispensing the product.

(g)

Records and Reports. The pharmacist-in-charge shall maintain appropriate 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 or its agents. These records shall include, as a minimum, the following:

1.	Patient profile;

2.	Prescription record;

3.	Inventories of the pharmacy;

4.	Biennial controlled substances inventories;

5.	Policy and procedures manual;

6.	Training manuals;

7.	Policies and procedures for cytotoxic waste, if applicable;

8.	Such other records and reports as may be required by law and rules and regulations of the Board of Pharmacy.

9.

Delivery Service. The pharmacist-in-charge is responsible for the environmental control of all products shipped or delivered, and must ensure that all drug products are shipped in compliance with O.C.G.A. 26-4-60(a)(11). Therefore, any compounded, sterile parenteral product that is frozen, or requires refrigeration, must be shipped or delivered to a patient in appropriate coolers and stored appropriately in the patient's home.

Rule 480-21-.06 Cytotoxic Agents

The following additional requirements are necessary for those retail pharmacies providing home health care services that routinely prepare chemotherapy agents to insure the protection of the personnel involved:

(a)	All chemotherapy agents should be compounded in a vertical flow, Class II, biological safety cabinet. If possible, other products should not be compounded in this cabinet.

(b)	Protective apparel shall be worn by personnel compounding chemotherapy drugs. This shall include disposable masks, gloves, and gowns with tight cuffs.

(c)	Proper aseptic and safety techniques shall be used by personnel compounding chemotherapy agents. This shall include, at a minimum, utilizing syringes and sets with luer-lock fittings, and wrapping alcohol swabs around needle and neck of vials when withdrawing cytotoxic solutions from a vial.

(d)	Appropriate disposal procedures for cytotoxic waste must be developed that comply with applicable state and federal regulations.

(e)	Written policies and procedures for handling both major and minor spills of cytotoxic agents must be developed.

(f)	Prepared doses of chemotherapy must be dispensed and shipped or delivered in a manner to minimize the risk of accidental rupture of the primary container.

Rule 480-21-.07 Patient Care Guidelines

(1)

Primary Provider. There shall be a designated practitioner responsible for the patient's medical care. There shall be a clear understanding between the practitioner, the patient, and the pharmacist of the responsibilities of each in the areas of the delivery of care, the monitoring of the patient, and the reimbursement for services. The responsibilities of each person shall be documented in the patient's profile.

(2)	Patient Counseling A pharmacist shall provide to the patient or patient's care-giver any information required for the use of the drugs, supplies and equipment being dispensed. The pharmacist must document the patient's counseling in the pharmacy's patient profile.

(3)	Pharmacist-Patient Relationship. It is imperative that a pharmacist-patient relationship be established and maintained throughout the patient's course of therapy. The patient should be contacted by the pharmacist at least quarterly. This contact shall be documented in the patient's profile.

(4)

Patient Monitoring. The pharmacist should have access to clinical and laboratory data concerning each patient and should monitor each patient's response to his drug therapy. Any unexpected or untoward response should be reported to the prescribing physician. In the absence of the pharmacist monitoring, it shall be documented in the patient's profile, which health care provider has assumed this responsibility.

Rule 480-21-.08 Quality Control

There shall be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product shall be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications.

(a)	Hood Certification. All laminar flow hoods shall be certified by Federal Standard 209B for operational efficiency at least every 12 months. Appropriate records shall be maintained.

(b)	Prefilters. Prefilters for the clean air source shall be replaced on a regular basis and these activities shall be documented.

(c)	End Product Sampling. There shall be written documentation that the end product has been tested on a sampling basis for microbial contamination.

(d)	Bulk Compounding. If bulk compounding of parenteral solutions is performed utilizing nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine. This process must include testing for sterility and pyrogens.

(e)	Expiration Dates. If the product is assigned a lengthy expiration date (anything exceeding 10 days) there must be in-house data or data in the literature to assure the sterility and stability of the product at the time it is used by the patient.

(f)	Quality Control Audits. There shall be documentation of quality assurance audits at regular, planned intervals.

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