SUBCHAPTER III
Manufacture, Distribution, and Dispensing
SECTIONS
§ 1131. Authority of director to promulgate rules and regulations.
§ 1132. Registration—Required—Exceptions.
§ 1133. Registration—Criteria for granting; Effect; Compliance with federal law.
§ 1134. Registration—Revocation or suspension—Grounds; Limitation of effect; Sealing of substances; Notice to bureau.
§ 1135. Registration—Revocation or suspension—Notice and hearing.
§ 1136. Registration—Records.
§ 1137. Order forms for substances in schedules I or II.
§ 1138. Prescriptions.
The director is authorized to promulgate rules in accordance with chapter 2 of title 17 of this code and charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances within the Trust Territory.
Editor's note: PL 5-34 repealed chapter 2 (Trust Territory Administrative Procedure) of title 17 of this code in its entirety. Chapter 1 of title 17 of this code is on Administrative Procedures of the FSM. See 17 F.S.M.C. 102.
(1) Every person who manufactures, distributes, or dispenses any controlled substance within the Trust Territory or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance within the Trust Territory shall obtain annually a registration issued by the director in accordance with the rules made by him.
(2) Persons registered by the director under this chapter to manufacture, distribute, dispense, or conduct research with controlled substances may possess, manufacture, distribute, dispense, or conduct research with those substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
(3) The following persons need not register and may lawfully possess controlled substances under the provision of this chapter:
(a) a common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance is in the usual course of his business or employment;
(b) an ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or in lawful possession of a schedule V substance.
(4) The director may, by rule, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.
(5) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances.
(6) The director or his designee may inspect the establishment of a registrant or applicant for registration in accordance with the rules promulgated by him.
(1) The director shall register an applicant to manufacture or distribute controlled substances included in schedules I through V of subchapter II of this chapter unless he determines that the issuance of that registration is inconsistent with the public interest. In determining the public interest, the director shall consider the following factors:
(a) maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;
(b) compliance with applicable law;
(c) prior conviction record of applicant under Federal, State and local laws relating to controlled substances;
(d) past experience in the manufacture or distribution of controlled substances, and the existence in the establishment of effective controls against diversion;
(e) furnishing by the applicant of false or fraudulent material in any application filed under this chapter;
(f) suspension or revocation of the applicant's Federal registration to manufacture, distribute, or dispense controlled substances as authorized by Federal law; and
(g) any other factors relevant to and consistent with the public health and safety.
(2) Registration granted under subsection (1) of this section shall not entitle a registrant to manufacture and distribute controlled substances in schedule I or II other than those specified in the registration.
(3) Practitioners must be registered to dispense any controlled substances or to conduct research with controlled substances in schedules II through V if they are authorized to dispense or conduct research under the law of the Trust Territory. The director need not require separate registration under this subchapter for practitioners engaging in research with non-narcotic controlled substances in schedules II through V where the registrant is already registered under this subchapter in another capacity. Practitioners registered under Federal law to conduct research with schedule I substances may conduct research with schedule I substances within the Trust Territory upon furnishing evidence of that Federal registration.
(4) Compliance by manufacturers and distributors with the provisions of the Federal law respecting registration (excluding fees) shall be deemed compliance with this section.
(1) A registration pursuant to section 1133 of this chapter to manufacture, distribute, or dispense a controlled substance, may be suspended or revoked by the director upon a finding that the registrant:
(a) has materially falsified any application filed pursuant to this chapter or required by this chapter;
(b) has been convicted of any violation under this chapter or any law of the United States, or of any state or territory, relating to any substance defined herein as a controlled substance; or
(c) has had his Federal registration suspended or revoked by competent Federal authority and is no longer authorized by Federal law to engage in the manufacture, distribution, or dispensing of controlled substances; or
(d) has violated any regulation promulgated by the director relating to subchapter III of this chapter;
(e) will abuse or unlawfully transfer such substances or that the registrant will fail to safeguard adequately his supply of such substances against diversion into other than legitimate channels of distribution.
(2) The director may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exists.
(3) In the event the director suspends or revokes a registration granted under section 1133 of this chapter, controlled substances owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may in the discretion of the director be placed under seal. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances shall be forfeited.
(4) The bureau shall promptly be notified of all orders suspending or revoking registration and all forfeitures of controlled substances.
(1) Before denying, suspending or revoking a registration, or refusing a renewal of registration, the director shall serve upon the applicant or registrant in accordance with chapter 2 of title 17 of this code notice to show cause why registration should not be denied, revoked, or suspended, or why the renewal should not be refused. The notice to show cause shall contain a statement of the basis therefor and shall call upon the applicant or registrant to appear before the director at a time and place not less than thirty days after the date of service of the notice, but in the case of a denial or renewal of registration the show cause notice shall be served not later than thirty days before the expiration of the registration. These proceedings shall be conducted in accordance with chapter 2 of title 17 of this code without regard to any criminal prosecution or other proceeding. Proceedings to refuse renewal of registration shall not abate the existing registration which shall remain in effect pending the outcome of the administrative hearing.
(2) The director may suspend, without a notice to show cause, any registration simultaneously with the institution of proceedings under section 1134 of this chapter, or where renewal of registration is refused, if he finds that there is an imminent danger to the public health or safety which warrants this action. The suspension shall continue in effect until the conclusion of the proceedings, including judicial review thereof, unless sooner withdrawn by the director or dissolved by a court of competent jurisdiction.
Editor's note: PL 5-34 repealed chapter 2 (Trust Territory Administrative Procedure) of title 17 of this code in its entirety. Chapter 1 of title 17 of this code is on Administrative Procedures of the FSM. See 17 F.S.M.C. 102.
Persons registered to manufacture, distribute, or dispense controlled substances under this chapter shall keep records and maintain inventories in conformance with the record-keeping and inventory requirements of Federal law and in accordance with any rules or regulations adopted by the director pursuant to the provisions of this chapter.
Controlled substances in schedules I and II shall be distributed by a registrant to another registrant only pursuant to an order form. Compliance with the provisions of Federal law respecting order forms shall be deemed compliance with this section.
(1) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, no controlled substance in schedule II may be dispensed without the written prescription of a practitioner.
(2) In emergency situations, as defined by rule of the director, schedule II drugs may be dispensed upon oral prescription of a practitioner reduced promptly to writing and filled by the pharmacy. Prescriptions shall be retained in conformity with the requirements of section 1136 of this chapter. No prescription for a schedule II substance may be refilled.
(3) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a controlled substance included in schedules III or IV which is a prescription drug, shall not be dispensed without a written or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six months after the date thereof or be refilled more than five times, unless renewed by the practitioner.
(4) A controlled substance included in schedule V shall not be distributed or dispensed other than for a medical purpose.
(5) No prescription for a controlled substance shall be filled or refilled with more than a 30-day supply, based upon the dosage units contained in the prescription.