Hypodermic Needles, Syringes, and Other Such Instruments (216-RICR-20-15-6)
These amended Rules and Regulations Governing Hypodermic Needles, Syringes, and Other Such Instruments are promulgated pursuant to the authority set forth in R.I. Gen. Laws 21-28-3.01, and are established for the purpose of promoting public health by permitting the sale of hypodermic needles and syringes in licensed pharmacies and adopting provisions governing hypodermic needles, syringes, and other such instruments without the need for a prescription.
A. “Authorized pharmacy personnel” means a person who is licensed, registered, or enrolled by the Department pursuant to R.I. Gen. Laws Chapter 5-19 and the Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
B. "Department" means the Rhode Island Department of Health.
C. “Director” means the Director of the Rhode Island Department of Health.
D. “Pharmacy” means that portion or part of a premises where prescriptions are compounded and dispensed, including that portion utilized for the storage of prescription drugs or legend drugs, and which is licensed pursuant to R.I. Gen. Laws Chapter 5-19 and the Department of Health’s Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
6.3 Sale of Hypodermic Needles and Syringes in Licensed Pharmacies
6.3.1 General Requirements
As of September 1, 2000, a prescription shall no longer be required for each sale of a hypodermic syringe(s), needle(s), or any instrument adapted for the administration of drugs by injection.
Hypodermic needles and syringes shall be sold only in licensed pharmacies.
Hypodermic needles and syringes shall be stored in the pharmacy. Access to hypodermic needles and syringes shall be by authorized pharmacy personnel only.
Upon each sale of a hypodermic needle(s) and syringe(s), the pharmacist shall make available to the purchaser, information on the safe disposal of hypodermic syringes or needles that shall include:
Information on the safe disposal of home-generated medical waste; and
A list of local disposal locations; and/or
A telephone number to call for information on local disposal sites and methods of disposal.
Pharmacists may also provide purchasers with information on drug addiction treatment, including a local telephone number to get assistance.
6.3.2 Pharmacy Certification
Pharmacy is registered as a regulated medical waste generator with the Department; or
Pharmacy is an established site for the collection for home-generated medical waste in a medical waste program certified by the Director, or provides information to purchasers that lists the locations of the local collection sites for home-generated medical waste; or
Pharmacy provides written information relating to the safe disposal of hypodermic needles and syringes.
When there is a change in registrant, the incoming registrant shall certify participation in activities as outlined in § 5.3.2(A) of this Part.
6.3.3 Destruction of Excess, Undesired, and Contaminated Hypodermic Needles, Syringes, or Other Such Instruments
The legal destruction of hypodermic needles, syringes or other such instruments is the responsibility of the last entitled or authorized possessor.
Methods of Disposal: In accordance with the requirements of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island, the following methods of disposal are intended to accomplish the purpose of adequate final destruction without danger of contamination of or injury to waste disposal personnel and to prevent diversion of the instruments or transmission of communicable diseases to the general population.
1. The requirements cited below shall apply to all health care facilities and individuals licensed by the Department of Health and authorized to handle needles, syringes, and other such instruments.
a. Pursuant to R.I. Gen. Laws § 21-29.1-1, all facilities or persons legally entitled to use disposable syringes and needles including but not limited to hospitals, physicians, skilled nursing and intermediate care facilities, shall destroy them after one (1) use. Any violation of this provision shall constitute a misdemeanor.
b. Excess and undesired needles, syringes and other such instruments shall be stored in impervious, rigid, puncture-resistant containers for disposal. Intact needles must be placed directly into the collection containers (i.e., without recapping, clipping, breaking or compacting) unless the person can demonstrate that an alternative is feasible and the alternatives are approved by the Department of Health, or that such action is required by a specific medical procedure.
c. Personnel handling disposal waste materials such as needles, syringes, and other such instruments may treat and destroy such waste on-site in a Department of Environmental Management (DEM)-permitted incinerator or by a DEM-approved alternative treatment/destruction technology or prepare the regulated medical waste for off-site transport by a DEM-permitted medical waste transporter.
d. Containers with used or unused needles, syringes, and other sharps may be treated and destroyed on-site in a DEM-permitted incinerator or by a DEM-approved alternative medical waste treatment/destruction technology, or at an off-site treatment and destruction facility.
A. If any provision of these regulations or the application thereof to any facility or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provision of the regulations are declared to be severable.
|Title||216||Rhode Island Department of Health|
|Subchapter||15||Information for Health Care Professionals|
|Part||6||Hypodermic Needles, Syringes, and Other Such Instruments (216-RICR-20-15-6)|
|Type of Filing||Technical Revision|
Regulation Authority :
R.I. Gen. Laws 21-28-3.01
Purpose and Reason :
This Technical Revision being promulgated to reformat the rule into the RICR format for the Rhode Island Administrative Code. There are no substantive changes.