[Adopted 1-17-2017 by L.L. No. 1-2017]
This article shall be known as "the Tobacco-Free Pharmacies
Act."
As used in this article, the following terms shall have the
meanings indicated:
COUNTY
The County of Rockland, New York.
DEPARTMENT
The Rockland County Department of Health.
PHARMACY
Any place in which drugs and medical components are possessed
for the purpose of preparing, compounding, preserving or dispensing
of drugs, medicines and therapeutic devices on the basis of prescriptions
and/or registered as a pharmacy pursuant to § 6802 of the
New York Education Law and are offered for sale at retail by advertising
or otherwise. This includes facilities and retailers that maintain
a pharmacy within their establishment.
TOBACCO PRODUCTS
Any product made or derived from tobacco that is intended
for human consumption, including, but not limited to, any component,
part or accessory of a tobacco product, whether or not the product
contains nicotine, cigarettes, chewing tobacco, cigars, powdered tobacco,
shisha, herbal cigarettes, electronic cigarettes, electronic liquids,
rolling paper and smoking paraphernalia.
No pharmacy located in Rockland County shall sell or cause to
be sold tobacco products.
This article shall take effect within 60 days from filing in
the Office of the Secretary of State.
[Adopted 2-7-2017 by L.L.
No. 2-2017]
This article may be cited as the "Pharmacy Take-Back Act."
The purpose of this article is to protect the health, safety
and welfare of the public and of the environment by providing for
the safe and orderly collection and disposal of unused drugs; and
by placing responsibility for end-of-life management of drug products
on the manufacturers of the products, while encouraging product design
that minimizes negative impacts on human health and the environment
at every stage of the product's lifecycle.
For the purposes of this article the following terms have the
meanings given below:
CONSUMER GENERATORS
Residents of single-and multiple-family residences or other
locations who possess, dispose of or abandon household drugs. "Consumer
generators" does not include drug seizures by law enforcement, pharmacy
waste, business waste, or any other source identified by the Department
as a non-consumer source.
CONTROLLED SUBSTANCE
Any substance listed under New York Public Health Law § 3306
or 21 U.S.C. §§ 812 and 813 or any successor legislation.
COSMETICS
A.
Articles intended to be rubbed, poured, sprinkled, or sprayed
on, introduced into, or otherwise applied to, the human body, or any
part thereof, for cleansing, beautifying, promoting attractiveness,
or altering the appearance;
B.
Articles intended for use as a component of any such articles;
and
C.
Cosmetics, as defined above, with expiration dates.
COUNTY
The County of Rockland, New York.
COVERED DRUG
All drugs as defined in 21 U.S.C. § 321(g)(1) of
the Federal Food, Drug and Cosmetic Act (FFDCA) covered under 21 U.S.C.
§ 353(b)(1) of the FFDCA, including both brand name and
generic drugs, and nonprescription drugs. "Covered drug" does not
include:
B.
Herbal-based remedies and homeopathic drugs, products, or remedies;
C.
Cosmetics, soap (with or without germicidal agents), laundry
detergent, bleach, household cleaning products, shampoos, sunscreens,
toothpaste, lip balm, antiperspirants, or other personal care products
that are regulated as both cosmetics and nonprescription drugs under
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 301
et seq. (2002)];
D.
Drugs for which producers provide a takeback program as part
of a Federal Food and Drug Administration managed risk evaluation
and mitigation strategy (21 U.S.C. § 3551);
E.
Drugs that are biological products as defined by 21 CFR 600.3(h)
as it exists on the effective date of this section if the producer
already provides a takeback program; and
F.
Pet pesticide products contained in pet collars, powders, shampoos,
topical applications, or other delivery systems.
DEPARTMENT
The Rockland County Department of Consumer Protection.
DRUG WHOLESALER
A business that sells or distributes drugs and covered drugs
for resale to an entity other than a consumer.
DRUGS
(1) Articles recognized in the official United States pharmacopoeia,
the official national formulary, the official homeopathic pharmacopoeia
of the United States, or any supplement of the formulary or those
pharmacopoeias; (2) substances intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in humans or
other animals; (3) substances, other than food, intended to affect
the structure or any function of the body of humans or other animals.
"Drugs" does not mean medical devices, their component parts or accessories.
ENTITY
A person other than an individual.
GENERIC DRUG
A drug that is chemically identical or bioequivalent to a
brand name drug in dosage form, safety, strength, route of administration,
quality, performance characteristics, and intended use, though inactive
ingredients may vary.
HAZARDOUS WASTE
Pharmaceutical waste that falls under the Federal Resource
Conservation and Recovery Act (RCRA) of 1976, as amended (42 U.S.C.
§ 6901 et seq.). This waste includes bulk chemotherapy drugs,
P-listed waste, U-listed waste and characteristic hazardous waste.
MAIL-BACK PROGRAM
A system whereby consumer generators of unwanted products
obtain prepaid and preaddressed mailing envelopes in which to place
unwanted products for shipment to an entity that will dispose of them
safely and legally.
MANUFACTURE
The production, preparation, propagation, compounding, or
processing of drugs, but does not include the activities of a repackager,
wholesaler or medical practitioner.
MANUFACTURER
A person, company, corporation or other entity engaged in
the manufacture of drugs.
MEDICAL WASTE
Any biohazardous, pathology, pharmaceutical, or trace chemotherapy
waste not regulated by the Federal Resource Conservation and Recovery
Act (RCRA) of 1976, as amended; sharps and trace chemotherapy wastes
generated in a health care setting in the diagnosis, treatment, immunization,
or care of humans or animals; waste generated in autopsy or necropsy;
waste generated during preparation of a body for final disposition
such as cremation or interment; waste generated in research pertaining
to the production or testing of microbiologicals; waste generated
in research using human or animal pathogens; sharps and laboratory
waste that pose a potential risk of infection to humans generated
in the inoculation of animals in commercial farming operations; waste
generated from the consolidation of home-generated sharps; and waste
generated in the cleanup of trauma scenes.
PERSON
An individual, firm, sole proprietorship, corporation, limited-liability
corporation, general partnership, limited partnership, limited-liability
partnership, association, cooperative, or other legal entity, however
organized.
PHARMACY
Any place registered as a pharmacy pursuant to § 6802
of New York Education Law where the practice of pharmacy is conducted.
PLAN OPERATOR
The person, company or organization that develops, implements
and operates a product stewardship plan, including but not limited
to a producer or stewardship organization.
PLAN or PRODUCT STEWARDSHIP PLAN
A product stewardship plan required under this article that
describes the manner in which a product stewardship program will be
provided.
PRESCRIPTION DRUG
Any drug that by federal or state law may be dispensed lawfully
only on prescription.
PRODUCER
A.
Shall be determined, with regard to covered drugs that are sold,
offered for sale, or distributed in Rockland County, to mean one of
the following:
(1)
The person who manufactures covered drugs and who sells, offers
for sale, or distributes covered drugs in Rockland County under that
person's own name or brand.
(2)
If there is no person who sells, offers for sale, or distributes
covered drugs in Rockland County under the person's own name
or brand, the producer of covered drugs is the owner or licensee of
a trademark or brand under which the covered drugs are sold or distributed
in Rockland County, whether or not the trademark is registered.
(3)
If there is no person who is a producer of covered drugs for
purposes of Subsections A(1) and (2) of this definition, the producer
of covered drugs is the person who brings the covered drug into Rockland
County for sale or distribution.
B.
"Producer" does not include:
(1)
A retailer that puts its store label on a covered drug; or
(2)
A pharmacist who dispenses prescription drugs to, or compounds
a prescribed individual drug product for, a consumer.
PROVIDER
Any person or entity that sells or otherwise furnishes drugs
to consumers at a medical or veterinary office, clinic, hospital or
approved needle exchange program located in the County.
PUBLIC HEARING
Any hearing held by the Department or the County which is
open to the public for the purposes of collecting public comment.
It does not necessarily refer to meetings of the Legislature.
RETAILER
Any person or entity that sells drugs directly to consumers
at a business located in the County. To be subject to this article,
a retailer must belong to a chain of three or more retail establishments,
whether operating inside or outside of Rockland County, that are engaged
in the same general field of business and:
A.
Conduct business under the same business name; or
B.
Operate under common ownership or management or pursuant to
a franchise agreement with the same franchisor.
STEWARDSHIP ORGANIZATION
An organization designated by a group of producers to act
as an agent on behalf of each producer to operate a product stewardship
program.
UNWANTED PRODUCTS
Covered drugs no longer wanted by the owner or that have
been abandoned, discarded, or are intended to be discarded by the
owner.
The Department of Consumer Protection and the Department of
Health shall provide on its website a list of all producers participating
in product stewardship programs approved by the Department and a list
of all producers the Department has identified as noncompliant with
this article or any regulations adopted pursuant to this article.
This article shall take effect within 30 days from filing in
the Office of the Secretary of State.