These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 21-28-5.07 and 21-31-20, and are established for the purpose of adopting methods for the disposal of drugs in this state, and for the protection of the health, safety and welfare of the public.

These regulations hereby adopt and incorporate 21 C.F.R. § 1317 (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

A.Wherever used in these rules and regulations, the following terms shall be construed as follows:

1.“Abandoned drugs” means non-controlled or controlled substances that have been brought into the health care facility by a patient admitted to a health care facility and have been left behind by the patient or their family, or if the patient is deceased.

2."Controlled substance" means a drug, substance or immediate precursor in R.I. Gen. Laws § 21-28-2.08 Schedules I - V.

3."Health care facility" means any health care institution as defined in R.I. Gen. Laws § , and licensed according to the provisions of R.I. Gen. Laws Chapter .

4."Drug" means any drug so designated pursuant to the provisions of R.I. Gen. Laws § 21-31-2(8).

5."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies) state or political subdivision or instrumentality of the state.

Any health care facility or person licensed by the Rhode Island Department of Health that is lawfully in possession of excess or undesired controlled substances, including abandoned drugs brought into a health care facility, shall inventory and dispose of all such controlled substances in accordance with 21 C.F.R. § 1317 incorporated above at § 1.2 of this Part and all other applicable federal, state, and local regulations. Hazardous waste pharmaceuticals collected as abandoned drugs can be disposed of as either controlled substances or as hazardous waste as per the Department of Environmental Management’s Rules and Regulations for Hazardous Waste Management (§ 250-RICR-140-10-1.7.1(E)(2)).”

A.All other drugs (i.e., those not classified as controlled substances), including abandoned drugs brought into a health care facility, shall be the responsibility of the health care facility or person to dispose of as provided in one of the following ways:

1.Drugs may be disposed of as solid waste provided that all of the following conditions are met:

a.The drugs are rendered unrecognizable;

b.The drugs would not pose a threat to the public or to the environment; and

c.The drugs cannot be recycled. OR

2.The drugs may be disposed of as regulated medical waste (defined in Medical Waste Regulations (250-RICR-140-15-1)), through the use of an entity holding a regulated medical waste transporter permit issued pursuant to the requirements of the Medical Waste Regulations, 250-RICR-140-15-1, and in compliance with the Medical Waste Regulations, 250-RICR-140-15-1.

3.The Director of Health or her/his designee is authorized to:

a.Enter any premises where drugs, including controlled substances, are maintained and/or held for disposal pursuant to the requirements of this Part;

b.Inspect any and all aspects of the disposal process and related records; and

c.Obtain and test samples of any and all controlled substances being processed for disposal for the purpose of determining compliance with state and federal laws.