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2024 SESSION

24102013D
SENATE BILL NO. 607
Offered January 10, 2024
Prefiled January 10, 2024
A BILL to amend the Code of Virginia by adding in Article 1 of Chapter 33 of Title 54.1 a section numbered 54.1-3304.2, relating to central fill pharmacies.
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Patron-- McDougle
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Referred to Committee on Education and Health
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Be it enacted by the General Assembly of Virginia:

1. That the Code of Virginia is amended by adding in Article 1 of Chapter 33 of Title 54.1 a section numbered 54.1-3304.2 as follows:

§ 54.1-3304.2. Central fill pharmacies.

A. For purposes of this section:

"Central fill" means the filling of a prescription drug order by a central fill pharmacy permitted by the Commonwealth at the request of an originating pharmacy.

"Central fill pharmacy" means a permitted pharmacy facility that, upon the request of an originating pharmacy, performs the product fulfillment of the drug order and returns the filled prescription to the originating pharmacy for delivery to the patient or patient's agent or sends the filled prescription directly to the patient for non-federally controlled substances. A central fill pharmacy shall not be required to obtain a wholesale distributor permit. An out-of-state central fill pharmacy performing central fill for a pharmacy in the Commonwealth shall be registered as a nonresident pharmacy and shall be deemed in compliance as long as it follows the laws of the jurisdiction in which it is a resident.

"Originating pharmacy" means a pharmacy located in the Commonwealth or out-of-state that, upon receipt of a prescription drug order, requests a central fill pharmacy to perform the product fulfillment of the order and, upon receipt of the filled prescription drug order, delivers the prescription to the patient or patient's agent.

B. An originating pharmacy may outsource a prescription drug order filling to a central fill pharmacy permitted by the Commonwealth if the pharmacy:

1. Has the same owner or has entered into a written contract or agreement that outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations;

2. Shares a common electronic file or has appropriate technology to allow access to sufficient information that is necessary or required to dispense or process a prescription drug order;

3. Ensures all state and federal laws regarding patient confidentiality, network security, and use of shared databases are followed; and

4. Maintains the prescription information in a readily retrievable manner.

C. The pharmacist-in-charge of a central fill pharmacy:

1. Shall ensure that the pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency;

2. Shall ensure that the filled prescriptions are shipped in containers that are sealed in a manner that would show evidence of having been opened or tampered with;

3. May determine the appropriate ratio of technicians and support personnel at the facility per pharmacist, which may not exceed 12 pharmacy technicians and trainees to one pharmacist for a residential central fill pharmacy, and may, for nonresident pharmacies, utilize the appropriate ratio and supervision of technicians and support permitted by the state in which the pharmacy is located; and

4. May employ non-technicians to assist in non-dispensing functions such as inventory, delivery, receiving, or packing of completed prescription orders.

D. Prescriptions for controlled substances other than ones controlled in Schedule I may be filled by a central fill pharmacy and shall comply with both state and federal statutes and regulations.

E. To the extent a pharmacy is acting as a central fill pharmacy, it shall not:

1. Fill prescriptions provided directly by a patient or an individual practitioner; or

2. Provide or dispense cannabis products not approved by the Federal Drug Administration.

F. An originating pharmacy that outsources prescription filling to a central fill pharmacy shall, prior to outsourcing the prescription:

1. Notify patients that their prescription may be filled by another pharmacy; and

2. Provide the name of that pharmacy or notify the patient, if the pharmacy is part of a network of pharmacies under common ownership, that any of the network pharmacies may fill the prescription.

Patient notification shall be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.

G. A central fill pharmacy that delivers prescriptions directly to a patient shall provide written information regarding the prescription with the filled prescription and a toll-free phone number for patient questions. A pharmacist at the originating pharmacy shall offer the patient or the patient's agent information about the prescription drug or device in accordance with Board rules. The provisions of this subsection shall not apply to patients in facilities, including hospitals or nursing homes, where drugs are administered to patients by a person authorized to do so by law.

H. The central fill pharmacy shall:

1. Place on the prescription label:

a. The name and address of the originating pharmacy that receives the filled prescription for delivery to the patient or the patient's agent; and

b. In some manner indicate which pharmacy filled the prescription;

2. Comply with all other labeling requirements of federal and state law; and

3. Be exempt from signage requirements intended for patients.

I. A central fill policy and procedure manual shall be maintained at both pharmacies and shall be available for inspection. The originating and central fill pharmacies are required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall at a minimum contain:

1. An outline of the responsibilities of the central fill pharmacy and the originating pharmacy including:

a. Confidentiality and integrity of patient information procedures;

b. Drug utilization review;

c. Counseling responsibilities;

d. Procedures for return of prescriptions not delivered to a patient and procedures for invoicing medication transfers. Out-of-state pharmacies serviced by a Virginia licensed central fill pharmacy are deemed exempt from subsection A of § 54.1-3434.4 for intra-company transfers of prescription drugs and devices and are not required to register as a non-resident pharmacy;

e. Policies for operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems;

f. Requirements for safe delivery of prescriptions to patients;

g. Requirements for storage and shipment of prescription medication; and

h. Procedures for conducting an annual review of written policies and procedures and for documentation of this review.

2. Other responsibilities regarding proper handling of a prescription and delivery to a patient or a patient's agent pursuant to federal and state-controlled substances laws and regulations.

3. The pharmacist verification responsibilities requirements shall be deemed satisfied if:

a. The pharmacy establishes and follows a policy and procedure manual that complies with subdivision 1; and

b. The system is fully automated from the time the medication is stocked into the machine until a completed, labeled, and sealed prescription is produced by the system that is ready for dispensing to the patient. No manual intervention with the medication may occur after the medication is stocked into the system. For purposes of this subdivision, manual intervention shall not include preparing a finished prescription for mailing, delivery, or storage.

J. Each central fill pharmacy shall maintain records in accordance with the provisions of federal and state laws and regulations and shall be able to produce records as requested by the Board. The originating pharmacy records shall include the date the request for filling was transmitted to the central fill pharmacy. The central fill pharmacy records shall include:

a. The date the filled prescription was mailed or delivered by the central fill pharmacy to the originating pharmacy or patient; and

b. If provided directly to a patient, the name and address to which the filled prescription was shipped.

K. Any central fill pharmacy may maintain records in an alternative data retention system, including a data processing system or direct imaging system, if:

1. The records maintained in the alternative system contain all of the information required on the manual record; and

2. The data processing system is capable of producing a hard copy of the record upon the request of the Board, its representative, or other authorized local, state, or federal law-enforcement or regulatory agency.

L. A central fill pharmacy shall complete a pharmacy permit application provided by the Board and (i) provide the name of the owner, permit holder, and pharmacist-in-charge of the pharmacy for service of process and (ii) pay the required fee as set by the Board.

2. That the Board of Pharmacy shall promulgate regulations to implement the provisions of this act to be effective within 280 days of its enactment.