216-RICR-20-15-6
216-RICR-20-15-6. Hypodermic Needles, Syringes, and Other Such Instruments (version Technical Revision, 01/02/2002 to 01/04/2022)
6.1 Authority
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.
6.2 Definitions
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
The registrant of each
licensed pharmacy in the state shall certify to the Director, on a
form provided by the Department, his/her participation in an
appropriate activity for the safe disposal of hypodermic needles
and syringes. Activities shall include:
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.
6.4 Severability
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.