N.Y. Public Health Law § 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.