reglab/statecodes huggingface dataset:
2023 New York Laws › PBH - Public Health › Article 32-A - Recombinant DNA Experiments › 3221 - Definitions.

§ 3221. Definitions. As used in this article:
1. "DNA" means deoxyribonucleic acid.
2. "Recombinant DNA" means DNA molecules which;
(a)  have  been formed by joining together DNA segments in a cell-free
system and which have the capacity to enter a cell and to  replicate  in
such  cell  either  autonomously or after they have become an integrated
part of such cell's genome; or
(b) are the result of a replication of the DNA molecules described  in
paragraph (a) of this subdivision.
3.  "Recombinant DNA activity" means the possession of recombinant DNA
by any person  and  any  activity  undertaken  by  any  person  for  the
production of recombinant DNA.
4.  "Person"  means any individual, corporation, partnership, or legal
entity of any kind, or a governmental agency, board or body.
5. "Cell-free system" means an environment  outside  of  any  cell  or
cellular organism.
2023 New York Laws › PBH - Public Health › Article 32-A - Recombinant DNA Experiments › 3222 - Certification.

§  3222. Certification. 1. One hundred eighty days after the effective
date of this article, no individual shall engage in  a  recombinant  DNA
activity  unless  such  individual  has been issued a certificate by the
commissioner or such individual is affiliated with and is  acting  under
the  direction  of and in a facility controlled by a person who has been
issued such a certificate.
2. Within one hundred eighty  days  of  the  effective  date  of  this
article, the commissioner shall prescribe regulations for the conduct of
recombinant  DNA  activity  which shall be the substantial equivalent of
sections II (entitled "containment")  and  III  (entitled  "experimental
guidelines")  of the recombinant DNA research guidelines of the National
Institutes of Health of the Department of Health, Education and  Welfare
published  in part II of the Federal Register for July seventh, nineteen
hundred seventy-six. If the National Institutes of Health guidelines are
revised, the commissioner shall revise the regulations for  the  conduct
of recombinant DNA activity accordingly.
3.  Within  one  hundred  eighty  days  of  the effective date of this
article the commissioner shall prescribe regulations for the:
(a)  training  and  qualifications   for   individuals   engaging   in
recombinant DNA activities;
(b) personnel health monitoring programs;
(c)   establishment   of  institutional  committees  to  oversee  such
activities; and
(d) periodic reports of the progress of such activities.
Regulations  adopted  pursuant  to  this  section  shall  be  reviewed
periodically   by  the  commissioner  in  light  of  current  scientific
knowledge to determine their continued adequacy and appropriateness.
4. The commissioner shall  by  regulation,  establish  procedures  for
application  for  a certificate to conduct recombinant DNA activity. All
proprietary information in applications or reports to the department  by
persons  certified pursuant to this section, not available to the public
or protected by a patent or copyright, shall be kept confidential.
5.  The  commissioner  may  approve  or  deny  an  application  for  a
certificate to engage in recombinant DNA activity or may approve it upon
such conditions as he shall prescribe.
6.  The  commissioner  by regulation may prescribe reasonable fees for
certification,  not  exceeding  the  cost  of  administrative   services
rendered by the department.
7.  The  commissioner shall, by regulation, provide for an abbreviated
certification process for the conduct of recombinant DNA activity  which
is subject to, and which is in compliance with, policies and regulations
promulgated  by  any agency of the federal government for the regulation
of recombinant DNA activity.
8. No local authority shall enact or enforce any local law, ordinance,
rule or regulation which would  regulate  or  restrict  recombinant  DNA
activity.  Further,  no  local  authority  shall  enact or duplicate any
provision of this article as local law, ordinance, rule or regulation.
2023 New York Laws › PBH - Public Health › Article 32-A - Recombinant DNA Experiments › 3223 - Enforcement.

§  3223.  Enforcement.    1. The commissioner may conduct scheduled or
  unscheduled inspections of facilities  where  certified  activities  are
  being conducted.
2.  The  commissioner may suspend a certificate on the ground that the
  holder unreasonably refused to  admit  a  department  inspector  to  the
  premises  where  a recombinant DNA activity was taking place, or for any
  other violation of a regulation promulgated pursuant  to  this  article.
  The  commissioner shall hold a hearing within fifteen days following any
  such suspension to determine whether the suspension was reasonable.  The
  commissioner  may  then  annul  the  suspension,  or  if  he  finds  the
  suspension to have been reasonable he  may  revoke  the  certificate  or
  continue its suspension for a period not to exceed three months.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 1 - General Provisions › 3300-A - Legislative Purposes.

§ 3300-a. Legislative purposes. The purposes of this article are:
1. to combat illegal use of and trade in controlled substances; and
2.  to  allow  legitimate use of controlled substances in health care,
  including palliative care; veterinary  care;  research  and  other  uses
  authorized  by  this  article or other law; under appropriate regulation
  and subject to this article, title eight of the education law, and other
  applicable law.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 1 - General Provisions › 3301 - Applicability of This Article to Actions and Matters Occurring or Arising Before and After the Effective Date.

§ 3301. Applicability of this article to actions and matters occurring
or  arising  before  and  after  the  effective  date.  Unless otherwise
expressly provided, or unless the context otherwise requires:
(a) the provisions of  this  article  shall  govern  and  control  the
possession,  manufacture, dispensing, administering, and distribution of
controlled substances with respect  to  any  matter,  act  or  omission,
arising or occurring on or after the effective date hereof;
(b)  the  provisions  of  this  article  do not apply to or govern any
matter, act, or omission arising or occurring  prior  to  the  effective
date  hereof.    Such  matters,  acts, or omissions must be governed and
construed according to provisions of  law  existing  at  the  time  such
matter,  act or omission arose or occurred in the same manner as if this
article had not been enacted.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 1 - General Provisions › 3304 - Prohibited Acts.

* §  3304.  Prohibited acts. 1. It shall be unlawful for any person to
  manufacture, sell, prescribe, distribute, dispense, administer, possess,
  have under his control, abandon, or  transport  a  controlled  substance
  except as expressly allowed by this article.
2.  It  shall  be unlawful for any person to possess or have under his
  control an official New York state prescription form except as expressly
  allowed by this article.
* NB Separately amended -- cannot be put together
* § 3304. Prohibited acts. a. It shall be unlawful for any  person  to
  manufacture, sell, prescribe, distribute, dispense, administer, possess,
  have  under  his  control,  abandon, or transport a controlled substance
  except as expressly allowed by this article.
b. It shall be unlawful  for  any  physician  practicing  medicine  as
  defined in section sixty-five hundred twenty-one of the education law to
  prescribe,  dispense  or  administer any amphetamines or sympathomimetic
  amine drug or compound thereof, designated as a schedule  II  controlled
  substance  pursuant  to section thirty-three hundred six of this article
  for the exclusive treatment of obesity, weight control or weight loss. A
  violation of the provisions of this subdivision shall not be grounds for
  prosecution under article two hundred twenty of the penal law.
* NB Separately amended -- cannot be put together
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 1 - General Provisions › 3308 - Powers and Duties of the Commissioner.

§  3308.  Powers  and duties of the commissioner. 1. The commissioner,
  and any representative authorized  by  him,  shall  have  the  power  to
  administer  oaths, compel the attendance of witnesses and the production
  of books, papers and records and to take proof and testimony  concerning
  all matters within the jurisdiction of the department.
2.  The  commissioner  is  hereby authorized and empowered to make any
  rules, regulations and determinations  which  in  his  judgment  may  be
  necessary  or  proper  to  supplement  the provisions of this article to
  effectuate the purposes and intent thereof or to clarify its  provisions
  so as to provide the procedure or details to secure effective and proper
  enforcement of its provisions.
3.  No  rule or regulation hereunder shall become effective unless, at
  least twenty-one days prior to the proposed effective date, persons  who
  have  conveyed  to the department in writing a request to be notified of
  proposed changes and additions to the department's rules and regulations
  under this article have been provided with the  text  of  such  proposed
  rules  and  regulations and have been given an opportunity to comment in
  writing thereon.
4.  The  rules,  regulations  and  determinations,   when   made   and
  promulgated  by  the  commissioner,  shall be the rules, regulations and
  determinations of the department and, until modified or rescinded, shall
  have the force  and  effect  of  law.  It  shall  be  the  duty  of  the
  department,  to enforce all of the provisions of this article and all of
  the rules, regulations and determinations made thereunder.
5. Notwithstanding any inconsistent provision  of  this  article,  the
  commissioner  in  consultation  with  the  commissioner  of education is
  hereby authorized to promulgate regulations regarding  the  prescribing,
  dispensing,  use and transmission of electronic prescriptions, which may
  be prescribed and dispensed in  lieu  of  an  official  New  York  state
  prescription.
6. The commissioner in consultation with the commissioner of education
  is  hereby authorized to promulgate regulations regarding the dispensing
  of out-of-state prescriptions.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 1 - General Provisions › 3309-B - Dispensing of Drug Adulterant Testing Supplies.

§ 3309-b. Dispensing  of  drug adulterant testing supplies. 1. As used
in this section:
(a) "Drug adulterant testing supplies" means any drug testing  product
that  is  used  to  determine whether a substance contains fentanyl or a
fentanyl analog.
(b) "Health care professional" means a person licensed, registered  or
authorized  pursuant  to  title  eight of the education law to prescribe
prescription drugs.
(c) "Pharmacist" means a person licensed  or  authorized  to  practice
pharmacy  pursuant  to article one hundred thirty-seven of the education
law.
2. A health care professional or pharmacist is authorized to  dispense
drug adulterant testing supplies to any person.
3.  Nothing in this section shall be construed to require a license to
distribute  drug  adulterant  testing  supplies  to  any   person.   The
commissioner  may  make  all  rules  and  regulations  necessary for the
implementation of this section.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3310 - Licenses for Manufacture or Distribution of Controlled Substances.

§  3310.  Licenses  for  manufacture  or  distribution  of  controlled
substances.  1. No person shall manufacture or distribute  a  controlled
substance in this state without first having obtained a license to do so
from the department.
2.  A  license  issued under this section shall be valid for two years
from the date of issue, except that in order to facilitate the  renewals
of  such licenses, the commissioner may upon the initial application for
a license, issue some licenses which may remain valid for  a  period  of
time  greater  than  two  years  but  not exceeding an additional eleven
months.
3. The fee for a license under this section shall be one thousand  two
hundred dollars; provided however, if the license is issued for a period
greater  than  two  years the fee shall be increased, pro rata, for each
additional month of validity.
4. Licenses issued under this section shall be effective only for  and
shall specify:
(a) the name and address of the licensee;
(b)  the  nature  of  the  controlled  substances,  either  by name or
schedule, or both, which may be manufactured or distributed;
(c) whether manufacture or distribution or both  such  activities  are
permitted by the license.
5.  Upon  application of a licensee, a license may be amended to allow
the licensee to relocate within the state or to add a  manufacturing  or
distributing  activity  or to add further substances or schedules to the
manufacturing or distribution activity permitted thereunder. The fee for
such amendment shall be two hundred fifty dollars.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3311 - Authority to Issue Initial Licenses, Amended Licenses, and to Renew Licenses.

§  3311. Authority to issue initial licenses, amended licenses, and to
  renew licenses.   1. Subject to  the  provisions  of  this  article  the
  commissioner is authorized to issue licenses authorizing the manufacture
  or distribution of controlled substances.
2. An application for a license, amendment of a license, or renewal of
  a  license  which,  if  granted,  would  authorize  the  manufacture  or
  distribution of a controlled substance which the applicant is  not  then
  authorized  to manufacture or distribute shall, with respect to any such
  additional authorization, be treated as an application  for  an  initial
  license.
3.  An  application for a license which, if granted, would authorize a
  licensee to continue to manufacture or distribute a controlled substance
  shall, with respect to such continued manufacture or distribution  only,
  be treated as an application for renewal of a license.
4.  A  late-filed application for the renewal of a license may, in the
  discretion of the commissioner, be treated  as  an  application  for  an
  initial license.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3312 - Application for Initial License.

§  3312.  Application  for  initial  license.   1. An applicant for an
initial license to manufacture or distribute controlled substances shall
furnish to the department such  information  as  it  shall  require  and
evidence that the applicant:
(a) and its managing officers are of good moral character;
(b)  possesses  sufficient  land,  buildings and equipment to properly
carry on the activity described in the application;
(c) is able to maintain effective control  against  diversion  of  the
controlled substances for which the license is sought;
(d)  is  able to comply with all applicable state and federal laws and
regulations  relating  to  the  manufacture  or  distribution   of   the
controlled substances for which the license is sought.
2. The application shall include the name, residence address and title
of each of the officers and directors and the name and residence address
of any person having a ten percentum or greater proprietary, beneficial,
equitable  or  credit interest in the applicant. Each such person, if an
individual, or lawful representative if a legal entity, shall submit  an
affidavit with the application setting forth:
(a)  any  position of management or ownership during the preceding ten
years of a ten percentum or greater  interest  in  any  other  business,
located  in  or outside this state, manufacturing or distributing drugs;
and
(b) whether such person or  any  such  business  has  been  convicted,
fined,   censured   or  had  a  license  suspended  or  revoked  in  any
administrative or judicial proceeding relating to or arising out of  the
manufacture or distribution of drugs; and
(c) such other information as the commisisoner may require.
3.  The  applicant  shall  be under a continuing duty to report to the
department any  change  in  facts  or  circumstances  reflected  in  the
application  on  any  newly discovered or occurring fact or circumstance
which is required to be included in the application.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3313 - Granting of Initial License.

§  3313. Granting of initial license.  1. The commisisoner shall grant
an initial license or amendment to a license as to one or  more  of  the
substances  or  activities  enumerated  in  the  application  if  he  is
satisfied that:
(a) the applicant will be able to maintain effective  control  against
diversion of controlled substances;
(b) the applicant will be able to comply with all applicable state and
federal laws;
(c)  the  applicant  and  its  officers are ready, willing and able to
properly carry on the manufacturing or distributing activity for which a
license is sought;
(d) the applicant possesses sufficient land, buildings  and  equipment
to properly carry on the activity described in the application;
(e) it is in the public interest that such license be granted; and
(f)  the  applicant  and  its  managing  officers  are  of  good moral
character.
2. If the commissioner is not satisfied that the applicant  should  be
issued  an  initial license, he shall notify the applicant in writing of
those factors upon which further evidence  is  required.  Within  thirty
days  of  the  receipt  of  such  notification, the applicant may submit
additional material to the commissioner or demand a hearing or both.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3315 - Applications for Renewal of Licenses to Manufacture or Distribute Controlled Substances.

§  3315.  Applications  for  renewal  of  licenses  to  manufacture or
distribute controlled substances.  1. An application for the renewal  of
any  license  issued  pursuant  to  this  title  shall be filed with the
department not more than six months nor less than four months  prior  to
the expiration thereof.
2. The application for renewal shall include such information prepared
in such manner and detail as the commissioner may require, including but
not limited to:
(a)  any  material  change  in  the circumstances or factors listed in
section thirty-three hundred twelve of this article;
(b) every known charge or investigation, pending or  concluded  during
the period of the license, by any governmental agency with respect to:
(i)  each  incident  or alleged incident involving the theft, loss, or
possible diversion of controlled substances manufactured or  distributed
by the applicant; and
(ii)  compliance by the applicant with the requirements of the federal
controlled substances act, or the laws of any state with respect to  any
substance listed in section thirty-three hundred six of this article.
3. An applicant for renewal shall be under a continuing duty to report
to  the department any change in facts or circumstances reflected in the
application or any newly discovered or occurring  fact  or  circumstance
which is required to be included in the application.
4. If the commissioner is not satisfied that the applicant is entitled
to  a renewal of such license, he shall within forty-five days after the
filing of the application serve upon the applicant or  his  attorney  of
record  in  person or by registered or certified mail an order directing
the applicant to show cause why his application for renewal  should  not
be  denied. Such order shall specify in detail the respects in which the
applicant has not satisfied the commissioner that the license should  be
renewed.
5.  Within  thirty  days  of  service of such order, the applicant may
either submit additional  material  to  the  commissioner  or  demand  a
hearing  or both.  If a hearing is demanded the commissioner shall fix a
date for hearing not sooner than fifteen days nor later than thirty days
after receipt of the demand, unless such time limitation  is  waived  by
the applicant.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3316 - Granting of Renewal of Licenses.

§  3316.  Granting  of  renewal of licenses. 1. The commissioner shall
renew a license unless he determines and finds that the applicant:
(a) is unlikely to maintain or be able to maintain  effective  control
against diversion; or
(b)  is  unlikely to comply with all federal and state laws applicable
to the manufacture  or  distribution  of  the  controlled  substance  or
substances for which the license is sought.
* (c)  is unlikely during the period of his or her license to complete
the reports or to pay the ratable share required by title two-A of  this
article on or before the required date. Prior evidence of non-compliance
shall constitute substantial evidence of such.
* NB Repealed June 30, 2029
2.  For  purposes  of  this section, proof that a licensee, during the
period of his license, has failed to maintain effective control  against
diversion  or  has  knowingly  or  negligently  failed  to  comply  with
applicable  federal  or  state  laws  relating  to  the  manufacture  or
distribution  of  controlled  substances,  shall  constitute substantial
evidence that the applicant  will  be  unlikely  to  maintain  effective
control  against  diversion or be unlikely to comply with the applicable
federal or state statutes during the period of proposed renewal.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3318 - Identification of Controlled Substances.

§  3318.  Identification  of  controlled  substances. 1. No controlled
substance may be manufactured or delivered within this state in solid or
capsule form unless it has clearly marked or imprinted  upon  each  such
capsule or solid:
(a)  an  individual  symbol  or  number  assigned  to  the  person who
manufactured the controlled substance in such form, and
(b) a code number or symbol assigned by the  commissioner  identifying
such substance or combination of substances.
2.  No controlled substance contained within a bottle, vial, carton or
other container, or in any way affixed or appended to or enclosed within
a package of any kind, and designed or intended  for  delivery  in  such
container  or  package  to  an ultimate consumer, shall be manufactured,
delivered or distributed within this  state  unless  such  container  or
package has clearly and permanently marked or imprinted upon it:
(a) an individual symbol or number assigned to the person who packaged
the controlled substance in such form; and
(b)  a  code number or symbol assigned by the commissioner identifying
such substance or combination of substances.
3. The commissioner shall assign a  code  number  or  symbol  to  each
controlled   substance,  and  in  his  discretion  for  combinations  of
substances, so as to provide ready  identification  of  such  substance.
Upon  application  by  a  manufacturer  of  controlled  substances,  the
commissioner shall assign to such manufacturer an identifying number  or
symbol.  Wherever  possible and practical, the commissioner shall assign
code numbers which conform to the national drug code system.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3319 - Distribution of Free Samples.

§  3319.  Distribution  of  free  samples.    It  shall be unlawful to
  distribute free samples of  controlled  substances,  except  to  persons
  licensed pursuant to title III of this article.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3320 - Authorized Distribution.

§  3320.  Authorized  distribution.  1.  Controlled  substances may be
  lawfully distributed within this state only to licensed distributors  or
  manufacturers,  practitioners,  pharmacists,  pharmacies,  institutional
  dispensers, registered outsourcing facilities, and laboratory,  research
  or  instructional facilities authorized by law to possess the particular
  substance distributed.
2.  A  person  authorized  to  obtain  a   controlled   substance   by
  distribution may lawfully receive such substance only from a distributor
  licensed pursuant to this article.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3321 - Exempt Distribution.

§  3321.  Exempt  distribution.  1.  The commissioner by regulation or
ruling may exempt from the licensing requirements of this title:
(a) the return of controlled substances to a manufacturer,  registered
outsourcing facility or distributor by a practitioner or pharmacy;
(b) the sale of controlled substances by a pharmacy or practitioner to
a  pharmacy  or  practitioner for the immediate needs of the pharmacy or
practitioner receiving such substances; and
(c) the disposition of controlled substances by  a  person  in  lawful
possession  thereof  who, not in the ordinary course of business, wishes
to discontinue such possession.
2. Records of such transactions shall be prepared and  maintained  and
reports filed in such manner as the commissioner shall require.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2 - Manufacture and Distribution of Controlled Substances › 3322 - Reports and Records.

§  3322.  Reports and records. 1. Persons licensed under this title or
  operating a registered outsourcing facility shall  maintain  records  of
  all  controlled  substances manufactured, compounded, received, disposed
  of, delivered or distributed by them. The record shall show the date  of
  receipt  or  delivery,  the name and address, and registration number of
  the person from whom received or to whom delivered or  distributed,  the
  kind  and  quantity  of substance received and delivered or distributed,
  the kind and quantity of substance produced or removed from the  process
  of manufacture and the date thereof.
2.  Any  person  licensed  under  this title or operating a registered
  outsourcing facility  shall  prepare  and  maintain  a  biennial  report
  setting  forth  the  current  inventory  of  controlled  substances, the
  quantities of controlled substances manufactured, compounded,  delivered
  or  distributed within the state during the period covered by the report
  and such other information  as  the  commissioner  shall  by  regulation
  prescribe. Maintaining for inspection a biennial inventory of controlled
  substances  prepared  and maintained in compliance with federal statutes
  and regulations shall be deemed in compliance with this section.
3. Any person licensed under this  title  or  operating  a  registered
  outsourcing  facility  shall  forthwith  notify  the  department  of any
  incident involving the theft, loss or possible diversion  of  controlled
  substances  manufactured,  compounded,  delivered  or distributed by the
  licensee or operator.
4. The records and reports required by this section shall be prepared,
  preserved, or filed in such manner and detail as the commissioner  shall
  by regulation prescribe.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances › 3324 - Licenses to Engage in Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances.

§  3324. Licenses to engage in research, instructional activities, and
chemical analysis relating to  controlled  substances.    1.  No  person
within  this  state  shall  manufacture,  obtain, possess, administer or
dispense a controlled substance for  purposes  of  scientific  research,
instruction or chemical analysis without having first obtained a license
to do so from the department.
2. A license issued under this title shall be valid for two years from
the date of issue.
3. The fee for a license under this title shall be forty dollars.
4.  Licenses  issued  under this title shall be effective only for and
shall specify:
(a) the name and address of the licensee;
(b) the nature of the project or projects permitted by the license;
(c) the nature of the controlled substance or substances to be used in
the project, by name if in schedule I, and by name or schedule  or  both
if in any other schedule;
(d) whether dispensing to human subjects is permitted by the license.
5.  Upon  application  of  a person licensed pursuant to this title, a
license may be amended to add a  further  activity  or  to  add  further
substances or schedules to the project permitted thereunder. The fee for
such amendment shall be twenty dollars.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances › 3325 - Authority to Issue Licenses; Applications.

§  3325. Authority to issue licenses; applications.  1. Subject to the
provisions of this title, the commissioner is authorized  to  license  a
person  to  manufacture,  obtain  and  possess, dispense, and administer
controlled substances for  purposes  of  scientific  research,  chemical
analysis or instruction.
2.  A  license  or  amendment  of  a  license  shall  be issued by the
department unless  the  applicant  therefor  has  failed  to  furnish  a
satisfactory  protocol pursuant to subdivision three of this section, or
a satisfactory statement pursuant to section 3326, and  proof  that  the
applicant:
(a) and its managing officers are of good moral character;
(b)  possesses  or  is  capable  of  acquiring  facilities,  staff and
equipment sufficient to carry on properly the proposed project  detailed
in the protocol or statement accompanying the application;
(c)  is  able  to  maintain effective control against diversion of the
controlled substances for which the license is sought;
(d) is able to comply with all applicable state and federal  laws  and
regulations  relating to the controlled substances for which the license
is sought.
3. An application for a license or for an amendment to a license shall
be accompanied by a detailed protocol setting forth:
(a) the nature of the proposed project;
(b) the proposed quantity or quantities of each  controlled  substance
involved;
(c)  the  qualifications  and competence of the applicant to engage in
such project;
(d) specific provisions for the safe administration or  dispensing  of
controlled  substances  to  humans,  if  such  is  contemplated, and the
proposed method of selecting humans;
(e) such other additional information as the commissioner may require.
4. The application for a license pursuant to this title shall  include
copies  of  all  papers filed with the Bureau, the Federal Food and Drug
Administration and any  other  governmental  agency,  whether  state  or
federal, in connection with the applicant's proposed project.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances › 3326 - Institutional Research Licenses.

§ 3326. Institutional research licenses.  1. Subject to the provisions
of this title, the commissioner is authorized to license an institution,
which  regularly  engages  in  research,  to  approve  specific projects
conducted under its immediate auspices.
2. An institution seeking a license pursuant  to  this  section  shall
make  application  in  the  same  manner  as  an applicant for a license
pursuant to section 3325.  However, such institution  shall  submit,  in
lieu  of  a  detailed  protocol  of  a  specific  project,  a  statement
including:
(a) the qualifications and such other data  as  the  commissioner  may
require  regarding  each  member of the committee within the institution
which will approve specific projects;
(b) a description of the system within the institution for  approving,
supervising and evaluating such projects.
3.  Upon  approval  of  each  specific project, such institution shall
forward to the commissioner a description of the project, the names  and
qualifications   of   the  individuals  working  thereon  and  of  those
individuals designated to supervise the project.  If  administration  or
dispensing  to  human  subjects  is  contemplated,  there  shall also be
included a description of the  provisions  for  safe  administration  or
dispensing.
4.  Such  institution  shall  forward  to  the  commissioner  periodic
progress reports and evaluations of,  as  well  as  amendments  to  each
project,  in  such  manner  and  in  such detail as the commissioner may
prescribe.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances › 3327 - Procedure.

§  3327.  Procedure.   1. A license or amendment to a license shall be
  issued or refused by the department within ninety days from the date  of
  filing of a completed application.
2.  Within  thirty days of notification of such refusal, the applicant
  may either submit additional material to the commissioner  or  demand  a
  hearing  or both.  If a hearing is demanded the commissioner shall fix a
  date for hearing not sooner than fifteen days nor later than thirty days
  after receipt of the demand, unless such time limitation  is  waived  by
  the applicant.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances › 3328 - Exemptions From Title.

§  3328. Exemptions from title.  The following persons engaging in the
following activities shall be exempt from the provisions of this title:
1. A practitioner lawfully administering, dispensing, or prescribing a
controlled substance in the course of his professional  practice  to  an
ultimate user for a recognized medical purpose;
2. A licensed manufacturer engaged in research upon non-human subjects
or  chemical  analysis  conducted  on  the  premises  specified  in  the
manufacturer's license;
3. A licensed distributor engaged in quality control analysis  at  the
premises specified in his license.
4.  A  practitioner  or  patient  participating in a clinical research
program on the therapeutic use of  marijuana  or  tetrahydrocannabinols.
(a)  Each  such  clinical  research program shall have received protocol
approval from the United States  Food  and  Drug  Administration,  shall
possess an effective investigational new drug application and shall have
been  registered  by  the Drug Enforcement Administration, United States
Department of Justice.
(b)  Each  such  clinical  research  program  authorized   under   the
provisions of article thirty-three-A of this chapter.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances › 3329 - Reports and Records.

§  3329.  Reports  and records.   1. Persons licensed under this title
  shall keep records showing the receipt, administration,  dispensing,  or
  destruction  of  all  controlled  substances and maintain the records in
  such manner  and  detail  as  the  commissioner,  by  regulation,  shall
  require.
2.  Persons  licensed  under  this  title  shall submit reports to the
  department  summarizing  the  activity  conducted  under  the   license.
  Included  in  such  report  shall  be a detailed inventory of controlled
  substances, and an  accounting  for  all  such  substances  received  or
  disposed  of  during  the  period  covered  by the report and such other
  information as the commissioner  shall,  by  regulation,  require.  Such
  reports  shall  be  filed  with  the  department  at  such  times as the
  commissioner may require.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3330 - Schedule I Substances.

§  3330. Schedule I substances.  No prescription may be made or filled
  for any controlled substance in schedule I nor  may  such  substance  be
  possessed,  distributed,  dispensed  or  administered except pursuant to
  title III of this article.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3334 - Emergency Oral Prescriptions for Schedule Ii Drugs and Certain Other Controlled Substances.

§ 3334. Emergency oral prescriptions for schedule II drugs and certain
other controlled substances. 1. In an emergency situation, as defined by
rule  or  regulation  of  the  department,  a  practitioner  may  orally
prescribe and a pharmacist may dispense to an ultimate  user  controlled
substances  in  schedule  II  and  those  schedule  III  or  schedule IV
controlled substances as the commissioner may, by  regulation,  require;
provided however the pharmacist shall:
(a)  contemporaneously  reduce  such prescription to writing or to the
extent authorized by federal requirements, to an electronic record;
(b)  dispense  the  substance  in   conformity   with   the   labeling
requirements  applicable  to  the  type  of  prescription which would be
required but for the emergency; and
(c) make a good faith effort to verify the practitioner's identity, if
the practitioner is unknown to the pharmacist.
2. No oral prescription shall be filled for a quantity  of  controlled
substances  which  would  exceed a five day supply if the substance were
used in accordance with the directions for use.
3. Within  seventy-two  hours  after  authorizing  an  emergency  oral
prescription,  the  prescribing practitioner shall cause to be delivered
to  the  pharmacist  the  original  of  an  official  New   York   state
prescription  or an electronic prescription. Such prescription shall, in
addition to the information  otherwise  required,  also  have  upon  the
official New York state prescription or upon the electronic prescription
the  words:  "Authorization for emergency dispensing." If the pharmacist
fails to receive such prescription he or she shall notify the department
in writing  or  electronically  within  seven  days  from  the  date  of
dispensing the substance.
4.   Such   official   New   York  state  prescription  or  electronic
prescription shall be endorsed, and  retained  and  filed  in  the  same
manner as is otherwise required for such prescriptions.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3335 - Dispensing by Online Dispensers of Controlled Substances.

§  3335.  Dispensing  by online dispensers of controlled substances. A
  controlled substance may be sold, delivered, or dispensed  by  means  of
  the  internet  but  only  in  accordance  with  this  article. An online
  dispenser shall file with the department by electronic means information
  concerning the dispensing by means of the internet,  of  any  controlled
  substances  in  such  manner  as  the  commissioner  by regulation shall
  require.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3337 - Oral Prescriptions Schedule Iii, Iv and v Substances.

§  3337.  Oral  prescriptions  schedule  III,  IV and V substances. 1.
Except as provided in section thirty-three hundred thirty-four  of  this
title, a practitioner may orally prescribe and a pharmacist may dispense
to  an  ultimate  user  controlled  substances in schedules III, IV or V
provided however the pharmacist shall:
(a) contemporaneously reduce such prescription to writing or,  to  the
extent authorized by federal requirements, an electronic record;
(b)   dispense   the   substance   in  conformity  with  the  labeling
requirements applicable to a prescription; and
(c) make a good faith effort to verify the practitioner's identity, if
the practitioner is unknown to the pharmacist.
2. No oral prescription shall be filled for a quantity  of  controlled
substances  which  would  exceed  a  five  day  supply if the controlled
substance were used in accordance with the directions  for  use,  except
that with respect to a schedule IV substance such prescription shall not
exceed  a  thirty-day  supply  or one hundred dosage units, whichever is
less; provided, however, that this provision  shall  not  apply  to  any
schedule IV controlled substance limited to a five day supply by section
thirty-three hundred thirty-four of this title.
3.   Within   seventy-two   hours   after  authorizing  such  an  oral
prescription, the prescribing practitioner shall cause to  be  delivered
to  the  pharmacist  an  official  New  York  state  prescription  or an
electronic  prescription.  If  the  pharmacist  fails  to  receive  such
prescription  he  or she shall make a record of such fact in such manner
and detail as the commissioner in consultation with the commissioner  of
education, by regulation, shall require.
4.   Such   official   New   York  state  prescription  or  electronic
prescription shall be endorsed, retained and filed in the same manner as
is otherwise required for such prescriptions.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3338 - Official New York State Prescription Forms.

§  3338.  Official  New York state prescription forms. 1. Official New
  York state prescription forms  shall  be  prepared  and  issued  by  the
  department  in the manner and detail as the commissioner in consultation
  with the commissioner of education may,  by  regulation,  require,  and,
  each  form  shall  be  serialized.  Such  forms  shall  be  furnished to
  practitioners  authorized   to   write   such   prescriptions   and   to
  institutional   dispensers.   Such  prescription  blanks  shall  not  be
  transferable.
2. Except as expressly  authorized  by  section  thirty-three  hundred
  thirty-four  or  thirty-three  hundred  thirty-seven  of  this  article,
  controlled substances may  be  prescribed  or  dispensed  only  upon  an
  official  New  York  state  prescription or, pursuant to regulations, an
  electronic prescription or out-of-state prescription.
3. The commissioner in consultation with the commissioner of education
  is hereby authorized and empowered to make rules  and  regulations,  not
  inconsistent  with this article, with respect to the retention or filing
  of  such  official  New  York  state  prescription   forms,   electronic
  prescriptions  and  out-of-state  prescriptions,  including  information
  required to be filed with the department, the maximum number of official
  prescription forms which may be issued at any one time,  the  manner  in
  which  such  forms shall be issued, the period of time after issuance by
  the department that such form shall remain valid for use, and the manner
  in which practitioners associated with institutional dispensers may  use
  such  forms,  or  any  other  matter of procedure or detail necessary to
  effectuate or clarify the provisions  of  this  section  and  to  secure
  proper and effective enforcement of the provisions of this article.
4.  Upon  a  finding  by  the commissioner that a person has willfully
  failed to comply with the provisions of this article,  the  commissioner
  may  revoke,  cancel  or  withhold  official New York state prescription
  forms which have been issued or for which application has been made.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3339 - Refilling of Prescriptions for Controlled Substances.

§  3339.  Refilling  of  prescriptions  for  controlled substances. 1.
  Prescriptions for a schedule II controlled substance and those  schedule
  III  or  schedule  IV  controlled  substances which the commissioner may
  require by regulation may not be refilled.
2. A prescription, except for a schedule II  controlled  substance  or
  those  schedule  III  or  schedule  IV  controlled  substances which the
  commissioner may require by regulation may be refilled not more than the
  number of times specifically  authorized  by  the  prescriber  upon  the
  prescription,  provided however no such authorization shall be effective
  for a period greater than six months from the date the  prescription  is
  signed.  In the event that the prescription authorizes the dispensing of
  more than a thirty day supply of schedule III, schedule IV or schedule V
  substances pursuant  to  regulations  of  the  commissioner  enumerating
  conditions  warranting  specified greater supplies, the prescription may
  be refilled only once.
3. Unless an earlier refilling is authorized  by  the  prescriber,  no
  prescription  for  a  controlled  substance may be refilled earlier than
  seven days prior to the date the previously dispensed  supply  would  be
  exhausted if used in conformity with the directions for use.
2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3341 - Institutional Dispensers Certificates of Approval.

§  3341.  Institutional  dispensers  certificates of approval.   1. No
institutional dispenser as herein before defined, shall receive, possess
or cause controlled substances to be administered or  dispensed  without
first  having  been  issued  a  certificate of approval authorizing such
activity by the commissioner.
2. Upon application of an institutional dispenser for a certificate of
approval, the  commissioner  shall  issue  such  certificate  if  he  is
satisfied that:
(a)  the  applicant  and  its  managing  officers  are  of  good moral
character;
(b)  the   applicant   possesses   the   necessary   land,   building,
paraphernalia and staff to properly carry on the activities described in
the application;
(c)  the  applicant will be able to maintain effective control against
diversion of controlled substances; and
(d) the applicant will be able to comply with all applicable state and
federal laws.
3. Institutional dispensers to whom such certificates have been issued
shall thereafter register biennially with the department.  The  fee  for
such certificate and for each biennial registration shall be one hundred
dollars.
4.  Certificates  and registrations issued under this section shall be
effective only for and shall specify:
(a) the name and address of the institutional dispenser;
(b) the nature of the controlled substance, or substances,  either  by
name  or schedule, or both, for which the certificate or registration is
issued.