reglab/housing_qa huggingface dataset:
NY Pub Health L § 3310 (2021)
2021 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.
NY Pub Health L § 3311 (2021)
2021 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.
NY Pub Health L § 3312 (2021)
2021 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.
NY Pub Health L § 3313 (2021)
2021 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.
NY Pub Health L § 3315 (2021)
2021 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.
NY Pub Health L § 3316 (2021)
2021 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, 2024   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.
NY Pub Health L § 3318 (2021)
2021 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.
NY Pub Health L § 3319 (2021)
2021 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.
NY Pub Health L § 3320 (2021)
2021 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.
NY Pub Health L § 3321 (2021)
2021 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.
NY Pub Health L § 3322 (2021)
2021 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.
NY Pub Health L § 3324 (2021)
2021 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.
NY Pub Health L § 3325 (2021)
2021 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.
NY Pub Health L § 3326 (2021)
2021 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.
NY Pub Health L § 3327 (2021)
2021 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.