Disposal of Drugs (216-RICR-20-20-1)
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapters 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.
1.2 Incorporated Materials
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. "Controlled substance" means a drug, substance or immediate precursor in R.I. Gen. Laws § 21-28-2.08 Schedules I - V.
3. "Drug" means any drug so designated pursuant to the provisions of R.I. Gen. Laws § 21-31-2(8).
4. "Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies) state or political subdivision or instrumentality of the state.
1.4 Disposal of Controlled Substances
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 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.
1.5 Disposal of All Other Drugs (i.e., Non-controlled Substances)
A. All other drugs (i.e., those not classified as controlled substances) 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 Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island, Rhode Island Department of Environmental Management), through the use of an entity holding a regulated medical waste transporter permit issued pursuant to the requirements of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island, Rhode Island Department of Environmental Management, and in compliance with the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste.
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.
|Title||216||Rhode Island Department of Health|
|Part||1||Disposal of Drugs (216-RICR-20-20-1)|
|Type of Filing||Amendment|
Regulation Authority :
R.I. Gen. Laws §§ 21-28-5.07 and 21-31-20
Purpose and Reason :
In accordance with the Administrative Procedures Act, R.I. Gen. Laws Section 42-35-3(a)(1), the following is a concise statement regarding this rulemaking for Disposal of Drugs (216-RICR-20-20-1). This amendment to the regulations creates Authority and Incorporated Materials sections, removes use of the outmoded term “legend” for those drugs which are not classified as controlled substances, corrects a statutory reference to the definition of drug, corrects a reference to the Code of Federal Regulations, and removes superfluous language. No comments were received during the public comment period; therefore no non-technical revisions were made to the regulations posted for public comment, and no justification for not implementing suggested revisions is required. In the development of this rule, consideration was given to: 1) alternative approaches; 2) overlap or duplication with other statutory and regulatory provisions; and 3) significant economic impact on small business. No alternative approach, duplication, or overlap was identified based on available information. RIDOH has determined that the benefits of this rule justify its costs.