Possession and Sale of Drugs and Devices for Administration of Drugs
Section 318:51-f
318:51-f Licensure of Research Organizations. –
I. No research organization shall procure or conduct research operations with prescription drugs by researchers without first having obtained a license from the office of professional licensure and certification according to the eligibility requirements set forth in rule by the pharmacy board.
II. No license shall be issued under this section unless the applicant has furnished proof:
(a) That the applicant is of good moral character or, if that applicant is an association or corporation, that the managing officers are of good moral character.
(b) That the applicant has sufficient space and security equipment as to properly carry on the research operations described in the application.
III. The license granted under this section shall at all times be displayed in a conspicuous place in the research organization facility for which it is issued.
IV. No license shall be issued under this section to research organizations for sale, dispensing, or distribution of prescription drugs.
(a) Prescription drugs are to be used solely for research purposes only.
(b) Use of controlled drugs is prohibited under the license for research organizations issued under this section.
(c) No research organization shall distribute prescription drugs directly to a consumer or a patient, or operate in such a manner as to endanger the public health.
(d) The research organization shall effectively destroy all prescription drugs in due course by means of conducting routine research operations or disposal by approved methods.
(e) The research organization shall maintain up-to-date and accurate records indicating:
(1) The amount of prescription drug destroyed.
(2) The date on which the prescription drug was destroyed.
(3) The manner or method by which the prescription drug was destroyed.
(f) Inventories and disposal transactions shall be maintained for 2 years and made available for inspection by the board's inspectors within a period of 72 hours from notice.
V. No license shall be granted to any research organization if any of its managing officers or researchers have within 5 years been convicted of a violation of any law of the United States, or of any state, relating to drugs, as defined by this chapter or RSA 318-B, or is an impaired person.
VI. Any licensee under this section is subject to the provisions of RSA 318:29.
VII. (a) The licensee shall, within 30 days of any change of information supplied in the original license application, notify the board.
(b) The notice required pursuant to subparagraph (a) shall contain the:
(1) Current New Hampshire license number of the research organization.
(2) Name of managing officers and researchers, old and new, if applicable.
(3) Address of the research organization, old and new, if applicable.
VIII. A new license shall be required for a change of ownership of an established research organization to a successor business entity which results in a change in the controlling interest in the research organization.