(a) substances recognized as drugs in the official United States
Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States,
or official National Formulary, or any supplement to any of them;
(b) substances intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or animals; and
(c) substances (other than food) intended to affect the structure or a
function of the body of man or animal. It does not include devices or
their components, parts, or accessories.
13. "Federal agency" means the Drug Enforcement Administration, United
States Department of Justice, or its successor agency.
14. "Federal controlled substances act" means the Comprehensive Drug
Abuse Prevention and Control Act of 1970, Public Law 91-513, and any act
or acts amendatory or supplemental thereto or regulations promulgated
thereunder.
15. "Federal registration number" means such number assigned by the
Federal agency to any person authorized to manufacture, distribute,
sell, dispense or administer controlled substances.
16. "Habitual user" means any person who is, or by reason of repeated
use of any controlled substance for non-legitimate or unlawful use is in
danger of becoming, dependent upon such substance.
17. "Institutional dispenser" means a hospital, veterinary hospital,
clinic, dispensary, maternity home, nursing home, mental hospital or
similar facility approved and certified by the department as authorized
to obtain controlled substances by distribution and to dispense and
administer such substances pursuant to the order of a practitioner.
18. "License" means a written authorization issued by the department
or the New York state department of education permitting persons to
engage in a specified activity with respect to controlled substances.
19. "Manufacture" means the production, preparation, propagation,
compounding, cultivation, conversion or processing of a controlled
substance, either directly or indirectly or by extraction from
substances of natural origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical synthesis, and
includes any packaging or repackaging of the substance or labeling or
relabeling of its container, except that this term does not include the
preparation, compounding, packaging or labeling of a controlled
substance:
(a) by a practitioner as an incident to his administering or
dispensing of a controlled substance in the course of his professional
practice; or
(b) by a practitioner, or by his authorized agent under his
supervision, for the purpose of, or as an incident to, research,
teaching, or chemical analysis and not for sale; or
(c) by a pharmacist as an incident to his dispensing of a controlled
substance in the course of his professional practice.
20. "Narcotic drug" means any of the following, whether produced
directly or indirectly by extraction from substances of vegetable
origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis:
(a) opium and opiate, and any salt, compound, derivative, or
preparation of opium or opiate;
(b) any salt, compound, isomer, derivative, or preparation thereof
which is chemically equivalent or identical with any of the substances
referred to in paragraph (a) of this subdivision, but not including the
isoquinoline alkaloids of opium;
(c) opium poppy and poppy straw.
21. "Opiate" means any substance having an addiction-forming or
addiction-sustaining liability similar to morphine or being capable of
conversion into a drug having addiction-forming or addiction-sustaining
liability. It does not include, unless specifically designated as
controlled under section thirty-three hundred six of this title, the
dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts
(dextromethorphan). It does include its racemic and levorotatory forms.
22. "Opium poppy" means the plant of the species Papaver somniferum
L., except its seeds.
23. "Person" means individual, institution, corporation, government or
governmental subdivision or agency, business trust, estate, trust,
partnership or association, or any other legal entity.
24. "Pharmacist" means any person licensed by the state department of
education to practice pharmacy.
25. "Pharmacy" means any place registered as such by the New York
state board of pharmacy and registered with the Federal agency pursuant
to the federal controlled substances act.
26. "Poppy straw" means all parts, except the seeds, of the opium
poppy, after mowing.
27. "Practitioner" means:
A physician, dentist, podiatrist, veterinarian, scientific
investigator, or other person licensed, or otherwise permitted to
dispense, administer or conduct research with respect to a controlled
substance in the course of a licensed professional practice or research
licensed pursuant to this article. Such person shall be deemed a
"practitioner" only as to such substances, or conduct relating to such
substances, as is permitted by his license, permit or otherwise
permitted by law.
28. "Prescribe" means a direction or authorization, by prescription,
permitting an ultimate user lawfully to obtain controlled substances
from any person authorized by law to dispense such substances.
29. "Prescription" shall mean an official New York state prescription,
an electronic prescription, an oral prescription or an out-of-state
prescription.
30. "Sell" means to sell, exchange, give or dispose of to another, or
offer or agree to do the same.
31. "Ultimate user" means a person who lawfully obtains and possesses
a controlled substance for his own use or the use by a member of his
household or for an animal owned by him or in his custody. It shall also
mean and include a person designated, by a practitioner on a
prescription, to obtain such substance on behalf of the patient for whom
such substance is intended.
32. "Internet" means collectively computer and telecommunications
facilities which comprise the worldwide network of networks that employ
a set of industry standards and protocols, or any predecessor or
successor protocol to such protocol, to exchange information of all
kinds. "Internet," as used in this article, also includes other
networks, whether private or public, used to transmit information by
electronic means.
33. "By means of the internet" means any sale, delivery, distribution,
or dispensing of a controlled substance that uses the internet, is
initiated by use of the internet or causes the internet to be used.
34. "Online dispenser" means a practitioner, pharmacy, or person in
the United States that sells, delivers or dispenses, or offers to sell,
deliver, or dispense, a controlled substance by means of the internet.
35. "Electronic prescription" means a prescription issued with an
electronic signature and transmitted by electronic means in accordance
with regulations of the commissioner and the commissioner of education
and consistent with federal requirements. A prescription generated on an
electronic system that is printed out or transmitted via facsimile is
not considered an electronic prescription and must be manually signed.
36. "Electronic" means of or relating to technology having electrical,
digital, magnetic, wireless, optical, electromagnetic or similar
capabilities. "Electronic" shall not include facsimile.
37. "Electronic record" means a paperless record that is created,
generated, transmitted, communicated, received or stored by means of
electronic equipment and includes the preservation, retrieval, use and
disposition in accordance with regulations of the commissioner and the
commissioner of education and in compliance with federal law and
regulations.
38. "Electronic signature" means an electronic sound, symbol, or
process, attached to or logically associated with an electronic record
and executed or adopted by a person with the intent to sign the record,
in accordance with regulations of the commissioner and the commissioner
of education.
39. "Registry" or "prescription monitoring program registry" means the
prescription monitoring program registry established pursuant to section
thirty-three hundred forty-three-a of this article.
40. "Compounding" means the combining, admixing, mixing, diluting,
pooling, reconstituting, or otherwise altering of a drug or bulk drug
substance to create a drug with respect to an outsourcing facility under
section 503B of the federal Food, Drug and Cosmetic Act and further
defined in this section.
41. "Outsourcing facility" means a facility that:
(a) is engaged in the compounding of sterile drugs as defined in
section sixty-eight hundred two of the education law;
(b) is currently registered as an outsourcing facility pursuant to
article one hundred thirty-seven of the education law; and
(c) complies with all applicable requirements of federal and state
law, including the Federal Food, Drug and Cosmetic Act.
Notwithstanding any other provision of law to the contrary, when an
outsourcing facility distributes or dispenses any drug to any person
pursuant to a prescription, such outsourcing facility shall be deemed to
be providing pharmacy services and shall be subject to all laws, rules
and regulations governing pharmacies and pharmacy services.
Structure New York Laws