216-40-15 R.I. Code R. § 1.6

Current through June 20, 2024

Section 216-RICR-40-15-1.6 - Specialized Pharmacy Practice

1.6.1Pharmaceutical Services: Nursing, Hospice Care, and Correctional Facilities

A. Any licensed pharmacy or licensed pharmacist that provides pharmaceutical services by contract to a nursing, hospice, or correctional facility shall comply with the following requirements:

1. Unless the nursing, hospice care, or correctional facility operates a licensed pharmacy and employs a director of pharmacy services, the nursing, hospice care, or correctional facility shall have a written agreement with a licensed resident or non-resident pharmacy to provide pharmaceutical services. The pharmacist-in-charge of the pharmacy shall supervise the entire spectrum of pharmaceutical services in the nursing, hospice care, or correctional facility.

a. If pharmaceutical services are provided by a non-resident pharmacy in a correctional facility, a State licensed pharmacist shall supervise those services.

2. The pharmacy and therapeutics committee, or its equivalent, shall consist of not less than a licensed pharmacist, a registered nurse, a physician and the administrator or a representative from administration and shall review all policies and procedures for the provision of pharmaceutical services to patients.

3. The pharmacist shall be responsible for the development of written policies and procedures that shall include, but not be limited to, the following:

a. Procedures for administering the services outlined in the written agreement with the facility

b. Policies and procedures necessary to ensure the safe use, administration, control and accountability of all drugs throughout the nursing, hospice care, or correctional facility in compliance with Federal and State laws. The pharmacist shall:

(1) Ensure that a valid medication or prescription order is received prior to the dispensing of any drug pursuant to §1.5.27(C) of this Part.

(2) Ensure that the drugs for each patient are kept and stored in the originally received containers and that the medication of one (1) patient shall not be transferred to another patient.

(3) Ensure that each cabinet, cart or other area utilized for the storage of drugs is locked and accessible only to authorized personnel.

(4) Provide for the timely delivery of drugs and biologicals from the pharmacy so a practitioner's orders for drug therapy can be implemented without undue delay.

c. Policies and procedures outlining the return or destruction on-site of wastage for all controlled substances and the proper disposal of legend drugs.

d. Policies governing appropriate storage of medications, an effective drug recall procedure, and labeling of all prescription drugs and biologicals in accordance with Federal and State requirements.

e. The pharmacist shall:

(1) Report any irregularities to the attending physician, medical director, and director of nurses. Reports shall show evidence of review and response; and

(2) Document in writing the performance of such review, which documentation shall be kept on file by the facility and shall be made accessible to inspectors upon request.

f. For nursing facilities, policies and procedures governing patient drug regimen reviews shall include procedures for reporting irregularities, and documenting that such reviews have been performed. The contracted pharmacy consultant shall review all medication orders or prescription orders with information on the patient profiles. The consultant pharmacist shall review the drug and biological regimen of each resident monthly.

4. A unit dose drug dispensing system or automated storage and distribution device may be utilized for the dispensing of drugs to patients in a licensed hospital, nursing, hospice care, or correctional facility. Such systems or devices shall be utilized in accordance with this Part.

5. Secure Delivery Area: Filled prescriptions may be delivered to health care facilities by pharmacy employees or authorized agents. Prescription medication may be accepted for delivery from a pharmacy during normal business hours under the general supervision of a pharmacist. However, when the pharmacy is closed for business prescription medication may only be accepted for delivery or dropped off at the pharmacy if:

a. The prescriptions are placed in a secured delivery area equipped with adequate security, including an alarm or comparable monitoring system, to prevent unauthorized entry, theft and diversion;

b. The secured delivery area appropriately safeguards product integrity in accordance with USP-NF requirements;

c. The secured delivery area is on the same premises as the pharmacy that filled the prescriptions;

d. The pharmacy and the approved agent solely have access to the secure delivery area;

e. The pharmacy maintains records of all persons who have accessed the secured delivery area and each prescription stored and removed for delivery;

f. The pharmacy maintains written policies and procedures for secured delivery area storage and removal of prescriptions;

g. A pharmacist or a pharmacy, by means of its agent, may accept the return of the following drugs or devices to the secured delivery area:

(1) Emergency kits;

(2) Prescriptions that were unsuccessfully delivered by the pharmacy, a pharmacist, or its agent; and

(3) Those deemed qualified for return pursuant to the requirements of this Part.

1.6.2Pharmaceutical Services: Nuclear/Radiologic Pharmacies

A. The practice of nuclear/radiologic pharmacy is hereby recognized as a specialty of pharmacy practice, regulated by the Department and the Board. This section applies only to pharmacies which are preparing and distributing, or redistributing radioactive material, not simply handling such material.

B. Policies and Procedures

1. This Part shall not apply to a nuclear medicine department within a medical institution which is licensed by another agency.

2. Nuclear pharmacies shall maintain records of acquisition, inventory, and disposition of all radioactive drugs and other radioactive materials, in accordance with the provisions of the "Rules and Regulations for the Control of Radiation [R 23-1.3 -RAD]."

3. All pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area. Detailed floor plans shall be submitted to the Department and the Rhode Island Radiation Control Agency before approval of the license.

4. Radiopharmaceuticals are to be dispensed only upon a prescription drug order, from a practitioner authorized to possess, use and administer radiopharmaceuticals.

5. The permit to operate a nuclear pharmacy is conditional upon an approved Rhode Island Radiation Control Agency license. Copies of the Rhode Island Radiation Control Agency inspection reports shall be made available upon request for Board inspection.

C. Personnel

1. A license to operate a pharmacy providing radiopharmaceutical services shall only be issued to a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of a qualified nuclear pharmacist. A qualified nuclear pharmacist shall be responsible for all operations of the pharmacy and shall be in personal attendance at all times that the pharmacy is open for business.

2. The nuclear pharmacy area shall be secured from unauthorized personnel.

D. Physical Requirements

Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided, meeting minimal space requirements established for all pharmacies in the State or as otherwise defined by the Board.

1.6.3Nonresident Pharmacies

A. Licensure: In order to ship, mail, or deliver prescription drugs and/or devices to a patient in Rhode Island, a non-resident pharmacy must be licensed by the Board and shall comply with all statutory requirements and this Part.

B. Agent of record: Each nonresident pharmacy that ships, mails, or delivers prescription drugs and/or devices to a patient in Rhode Island shall designate a resident agent in Rhode Island for service of process. Any such non-resident pharmacy that does not so designate a registered agent and that ships, mails, or delivers prescription drugs and/or devices in Rhode Island, shall be deemed an appointment by such non-resident pharmacy of the Rhode Island Secretary of State to be its true and lawful attorney upon whom may be served all legal process in any action or proceeding against such pharmacy growing out of or arising from such delivery. A copy of any such service of process shall be mailed to the non-resident pharmacy by the complaining party by certified mail, return receipt requested, postage prepaid, or by international certified mail, return receipt requested, postage prepaid, at the address of such non-resident pharmacy as designated on the pharmacy's application for licensure in Rhode Island. If any such pharmacy is not licensed in Rhode Island, service on the Rhode Island Secretary of State only shall be sufficient service.

C. Conditions of Licensure: As conditions of licensure, the nonresident pharmacy must comply with the following:

1. Maintain, at all times a valid unexpired license, permit or registration to operate the pharmacy in compliance with the laws of any other State in the United States or any Province or Territory of Canada in which it is located;

2. Provide a description of any final disciplinary action(s) by licensing boards in other states in the United States, United States Territories or Possessions, or any Provinces or Territories of Canada; as defined as discipline in those States, Provinces, or Territories and

3. Provide all information requested by the Board.

D. A pharmacy license will be issued to the owner who meets the requirements established pursuant to the Act and this Part. The owner of each pharmacy shall receive a license of location, which shall entitle the owner to operate such pharmacy at the location specified, or such other temporary location as the Director may approve, for the period ending on September 30^th of the current licensing cycle. Each such owner shall at the time of filing provide proof of payment of such fee, file with the Department on a provided form, a declaration of ownership and location. Such declaration of ownership and location filed with the Department shall be deemed presumptive evidence of ownership of the pharmacy specified on the license.

E. A license shall be issued to the owner and premise listed on the form and shall not be transferred. A license issued pursuant to this Part shall be the property of the Department and loaned to the licensee, and it shall be kept posted in a conspicuous place on the licensed premises. If a change in owner or premise listed in said firm occurs, the license becomes null and void.

F. It shall be the duty of the owner to immediately notify the Department of any proposed change of location or ownership.

G. In the event such license fee remains unpaid on the date due, no renewal or new license shall be issued except upon payment of the license renewal fee.

H. Reports and Complaints - Upon receipt of a complaint against the non-resident pharmacy, the Department shall forward the complaint to the other State (in the United States) or Canadian Provincial or Territorial boards where the nonresident pharmacy is licensed.

1.6.4Canadian Pharmacies

A. A Canadian pharmacy seeking licensure in Rhode Island shall, as a condition of licensure, comply at all times with the following requirements:

1. Only ship into Rhode Island products that have been approved by the United States Food and Drug Administration (FDA);

2. Provide written documentation acceptable to the Board that the Canadian pharmacy's importation of prescription drugs to Rhode Island residents is in compliance with all FDA and other applicable Federal laws and Regulations.

3. Provide a certificate of insurance in the name of the Department as certificate holder showing evidence of five million dollars ($5,000,000.00) of product liability insurance or other equivalent means of security acceptable to the Board.

a. The product liability insurance policy shall include U.S. Territories and shall be issued by an insurer that maintains at least an "A" rating from A.M. Best and a financial size category of at least Class "X."

b. Failure to maintain product liability insurance shall result in the revocation of the Canadian pharmacy's license to do business in Rhode Island.

c. The product liability insurance policy shall include a provision that stipulates that the Director shall be notified of the cancellation or failure to renew the insurance. Further, the policy shall be required to continue in effect for ten (10) days after written notice of the cancellation is given to the Director of the cancellation or termination of the product liability insurance policy by the issuing insurance company or companies in addition to any other notices which may be required by law.

4. Not perform therapeutic substitution (i.e., substitution of medications within a class) without the approval of the prescriber;

5. Provide patients with an opportunity to discuss matters that will enhance or optimize drug therapy with each patient or care giver of such patient. Such discussion, by telephone, electronic, or other acceptable means, shall include appropriate elements of patient counseling, as is appropriate for the patient in the professional judgment of the pharmacist.

6. Provide for the secure and confidential storage of confidential patient healthcare information with restricted access, including policies and procedures implemented to protect the integrity and confidentiality of patient healthcare information. Except as provided in R.I. Gen. Laws Chapter 5-37.3 or as specifically provided by State and Federal law, a patient's confidential healthcare information shall not be released or transferred without the written authorization of the patient or his/her authorized representative, on a consent form meeting the requirements set forth in R.I. Gen. Laws Chapter 5-37.3. Further, under no circumstances shall a patient's confidential healthcare information be provided to a third (3^rd) party for marketing, fundraising, or research purposes. Anyone who violates the provisions of R.I. Gen. Laws Chapter 5-37.3 may be held liable for actual and exemplary damages and other penalties set forth in R.I. Gen. Laws Chapter 5-37.3.

7. Provide and maintain all appropriate inventory controls in order to detect and document any theft, counterfeiting, or diversion of drugs or devices.

8. Have a procedure in place for handling recalls and withdrawals of drugs and devices, including the tracking of lot numbers, consistent with the requirements of § 1.13 of this Part. Such procedure shall be adequate to deal with recalls and withdrawals due to:

a. Any action initiated at the request of the U.S. FDA or any other Federal, State, or local law enforcement or other governmental agency, including the Board;

b. Any volunteer action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or

c. Any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.

9. Provide the patient with written documentation that indicates the country(ies) where the patient's medication(s) were manufactured.

10. Ensure that all drug labels are written in English and meet all requirements set forth in Rhode Island law and this Part.

B. A non-resident Canadian pharmacy shall not ship, mail, deliver, or otherwise dispense to a Rhode Island patient any of the following:

1. A controlled substance as defined in R.I. Gen. Laws § 21-28-1.02(7);

2. A biological product as defined in this Part;

3. An infused drug including peritoneal dialysis solution;

4. An intravenously injected drug;

5. A drug that is inhaled during surgery;

6. A parenteral drug;

7. A drug manufactured through one or more biotechnology processes including:

a. A therapeutic DNA plasmid product;

b. A therapeutic synthetic peptide product of not more than forty (40) amino acids;

c. A monoclonal antibody product for in-vivo use; and

d. A therapeutic recombinant DNA-derived product.

8. A drug required to be refrigerated at any time during manufacturing, packaging, processing, or holding;

9. A photoreactive drug.

C. The Canadian pharmacy shall provide the name and address of a Rhode Island resident upon whom notices or orders of the Department or process affecting the Canadian pharmacy may be served.

D. As a condition of licensure, a Canadian pharmacy shall agree that the statutes and Regulations of the State of Rhode Island will apply to all matters. Further, the Canadian pharmacy agrees that exclusive jurisdiction for any dispute with any Rhode Island citizen resides in the courts of the State of Rhode Island and further agrees and expressly consents to the exercise of personal jurisdiction in the courts of the State of Rhode Island in connection with any dispute, including any claim involving any Rhode Island citizen.

216 R.I. Code R. § 216-RICR-40-15-1.6

Amended effective 5/17/2021
Amended effective 12/8/2022