Legalization of Illicit Drugs

(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 authority is not satisfied that the applicant should be issued an initial license, it shall notify the applicant in writing of 11 those factors upon which further evidence is required. Within thirty 12 days of the receipt of such notification, the applicant may submit additional material to the authority or demand a hearing or both.

S 589. 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 author i ty not more than six months nor iess than four months prior to the expiration thereof.

19 2. The application for renewal shall include such information prepared in such manner and detail as the authority may require, including but not limited to:

(a) any material change in the circumstances or factors listed in 23 section five hundred eighty-seven of this title:

جاجا

(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

any

(ii) compliance by the applicant with the requirements of the federal controlled substances act, or the laws of any state with respect to substance listed in section five hundred sixty-six of this article. 3. An applicant for renewal shall be under a continuing duty to report to the authority 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 authority is not satisfied that the applicant is entitled to a renewal of such license, it 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 authority that the license should be

renewed.

thirty

5. Within days of service of such order, the applicant may either submit additional material to the authority or demand a hearing or both. If a hearing is demanded the authority shall fix a date for hearing not sooner than fifteen days nor later than thirty days after 48 receipt of the demand, unless such time limitation is waived by the applicant.

$590. Granting of renewal of licenses. 1. The authority shall renew a license unless it determines and finds that the applicant:

52 (a) is unlikely to maintain or be able to maintain effective control 53 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.

2. For purposes of this section, proof that a licensee, during the period of his license, has failed to maintain effective control against 3 diversion or has knowingly or negligently failed to comply with applica4 ble federal or state laws relating to the manufacture or distribution of 5 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.

S 591. 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:

13 (a) an individual symbol or number assigned to the person who manu14 factured the controlled substance in such form, and

20 21

(b) a code number or symbol assigned by the authority 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 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 authority identifying 26 such substance or combination of substances.

4444

3. The authority shall assign a code number or symbol to each controlled substance, and in its discretion for combinations of substances, SO as to provide ready identification of such substance. Upon application by a manufacturer of controlled substances, the authority shall assign to such manufacturer an identifying number or symbol. Wherever possible and practical, the authority shall assign code numbers which conform to the national drug code system.

S 592. Distribution of free samples. It shall be unlawful to distribute free samples of controlled substances, except to persons licensed pursuant to title IV of this article.

S 593. Authorized distribution. 1. Controlled substances may be lawfully distributed within this state only to licensed distributors or manufacturers, practitioners, pharmacists, pharmacies, institutional dispensers, 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.

S 594. Exempt distribution. 1. The authority by regulation or ruling may exempt from the licensing requirements of this title:

(a) the

return of controlled substances to a manufacturer 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

52 (c) the disposition of controlled substances by a person in lawful 53 possession thereof who, not in the ordinary course of business, wishes 54 to discontinue such possession.

2. Records of such transactions shall be prepared and maintained and 56 reports filed in such manner as the authority shall require.

23456

S 595. Reports and records. 1. Persons licensed under this title shall maintain records of all controlled substances manufactured, received, disposed of or distributed by them. The record shall show the date of receipt or delivery, the name and address, and registration number of 5 the person from whom received or to whom distributed, the kind and quan6 tity of substance received and 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 snall prepare and maintain a biennial report setting forth the current inventory of controlled substances, the quantities of controlled substances manufactured or distributed within the state during the period covered by the report and such other information as the authority 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 shall forthwith notify the authority of any incident involving the theft, loss or possible diver19 sion of controlled substances manufactured or distributed by the licensee.

4. The records and reports required by this section shall be pre22 pared, preserved, or filed in such manner and detail as the authority shall by regulation prescribe.

TITLE IV

RESEARCH, INSTRUCTIONAL ACTIVITIES, AND CHEMICAL
ANALYSIS RELATING TO CONTROLLED SUBSTANCES

27 Section 600. Licenses

to engage in research, instructional activities, and chemical analysis relating to controlled substances. 601. Authority to issue licenses; applications.

602. Institutional research licenses.

603. Procedure.

604. Exemptions from title.

605. Reports and records.

S 600. 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 authority.

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 twenty dollars. 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 of section five hundred sixtysix of this article, and by name or schedule or both if in any other schedule in this article;

51 (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 55 such amendment shall be ten dollars.

S 601. Authority to issue licenses; applications. 1. Subject to the provisions of this title, the authority is authorized to license a per son to manufacture, obtain and possess, dispense, and administer controlled Substances for purposes of scientific research, chemical 5 analysis or instruction.

123&578

2. A license or amendment of a license shall be issued by the authority 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 six hundred two of this title, and proof that the applicant:

(a) and its managing officers are of good moral character;

(D) 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:

(b) the proposed quantity or quantities of each controlled substance involved;

such project;

qualifications and competence of the applicant to engage in

27 (d) specific provisions for the safe administration or dispensing of 28 controlled substances to humans, if such is contemplated, and the

30 (e) such other additional information as the authority 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 fed34 eral, in connection with the applicant's proposed project.

35 S602.

Institutional research licenses. 1. Subject to the provisions 36 of this title, the authority is authorized to license an institution, 37 which reqularly engages in research, to approve specific projects con38 ducted under its immediate auspices.

39 2. An institution seeking a license pursuant to this section shall 40 make application in the same manner as an applicant for a license pur41 suant to section six hundred one of this title. However, such institu42 tion shall submit, in lieu of a detailed protocol of a specific project. a statement including:

(a) the qualifications and such other data as the authority may require regarding each member of the committee within the institution

which will approve specific projects;

47 (b) a description of the system within the institution for approving, 48 supervising and evaluating such projects.

49 3. Upon approval of each specific project, such institution shall 50 forward to the authority a description of the project, the names and 51 qualifications of the individuals working thereon and of those individu52 als designated to supervise the project. If administration or dispens53 ing to human subjects is contemplated, there shall also be included a description of the provisions for safe administration or dispensing.

123578

4. Such institution shall forward to the authority periodic progress reports and evaluations of, as well as amendments to each project, in such manner and in such detail as the authority may prescribe.

S603. Procedure. 1. A license or amendment to a license shall be issued or refused by the authority within ninety days from the date of 6 filing of a completed application.

2. Within thirty days of notification of such refusal, the applicant may either submit additional material to the authority or demand a hearing or both. If a hearing is demanded the authority 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.

S 604 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:

18 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 marihuana 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 the public health law.

32 $ 605. Reports and records. 1. Persons licensed under this title 33 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 authority, by regulation, shall require. 2. Persons licensed under this title shall submit reports to the authority 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 authority shall, by regulation, require. Such reports shall be filed with the authority at such times as the authority may require.

جاجا

S 2. Articles two hundred twenty and two hundred twenty-one of the penal law are REPEALED.

S 3. Article thirty-three of the public health law is REPEALED.

S 4. This act shall take effect on the first day of November next suc47 ceeding the date on which it shall have become a law; provided, however, 48 that the provisions of title one of article twenty-one of the executive 49 law, as added by section one of this act shall take effect immediately 50 and provided further, that effective immediately, the addition, amend51 ment and/or repeal of any rules or regulations necessary for the imple52 mentation of the foregoing sections of this act on their effective date 53 are authorized and directed to be made and completed on or before such 54 effective date.

« Anterior Continuar »

Libros

Legalization of Illicit Drugs: Hearing Before the Select Committee ..., Parte1