N.Y. Public Health Law § 3302: Definitions of terms of general use in this article

§ 3302. Definitions of terms of general use in this article. Except

where different meanings are expressly specified in subsequent

provisions of this article, the following terms have the following

meanings:

1. "Person with substance use disorder" means a person who habitually

uses a controlled substance for a non-legitimate or unlawful use, and

who by reason of such use is dependent thereon.

2. "Administer" means the direct application of a controlled

substance, whether by injection, inhalation, ingestion, or any other

means, to the body of a patient or research subject.

3. "Agent" means an authorized person who acts on behalf of or at the

direction of a manufacturer, distributor, or dispenser. No person may be

authorized to so act if under title VIII of the education law such

person would not be permitted to engage in such conduct. It does not

include a common or contract carrier, public warehouseman, or employee

of the carrier or warehouseman when acting in the usual and lawful

course of the carrier's or warehouseman's business.

4. "Controlled substance" means a substance or substances listed in

section thirty-three hundred six of this title.

5. "Commissioner" means commissioner of health of the state of New

York.

6. "Deliver" or "delivery" means the actual, constructive or attempted

transfer from one person to another of a controlled substance, whether

or not there is an agency relationship.

7. "Department" means the department of health of the state of New

York.

8. "Dispense" means to deliver a controlled substance to an ultimate

user or research subject by lawful means, including by means of the

internet, and includes the packaging, labeling, or compounding necessary

to prepare the substance for such delivery.

9. "Distribute" means to deliver a controlled substance, including by

means of the internet, other than by administering or dispensing.

10. "Distributor" means a person who distributes a controlled

substance.

11. "Diversion" means manufacture, possession, delivery or use of a

controlled substance by a person or in a manner not specifically

authorized by law.

12. "Drug" means

(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.