§ 4732 — Registration requirements; exemptions; inspections

Delaware § 4732

• Jurisdiction: Delaware
• Title: 16
• Part: Food and Drugs
• Ch. 47: UNIFORM CONTROLLED SUBSTANCES ACT
• Subch.: Regulation of Manufacture, Distribution and Dispensing of Controlled Substances

Text

(a) Any pharmacy, distributor, manufacturer, practitioner, including a practitioner who holds a practice privilege, interstate compact license, an interstate telehealth registration, or a military registration, researcher or other controlled substance registrant who has or proposes to engage in activities accordingly within this State must obtain biennially a registration issued by the Secretary in accordance with the Secretary’s rules.

(b) Any pharmacy, distributor, manufacturer, researcher or other controlled substance registrant is limited to those substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter.

(c) The following persons need not register and may lawfully possess controlled substances under this chapter:

(1) Any agent or employee of any registered manufacturer, distributor or dispenser of any controlled substance if the agent or employee is acting in the usual course of the agent’s or employee’s business or employment;

(2) A common or contract carrier or warehouseperson, or any employee thereof, whose possession of any controlled substance is in the usual course of business or employment; and

(3) 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.

(d) The Secretary may waive by rule the requirement for registration of certain manufacturers, distributors or dispensers if the Secretary finds it consistent with the public interest.

(e) A separate registration is required at each principal place of business or professional practice where the applicant, including other controlled substance registrants, manufactures, distributes, dispenses or conducts research with controlled substances.

(f) The Secretary or the Secretary’s representative may inspect the establishment of any registrant or applicant for registration in accordance with the Secretary’s rules.

(g) Every registrant under this chapter shall be required to report any change of professional or business address in such a manner as the Secretary may require by rule.

(h) As a condition of biennial renewal of registration, an applicant shall demonstrate, in such a form and by such evidence as the Secretary deems appropriate, that the applicant, if a licensed practitioner, as defined in this chapter, or such officer or employee of the applicant, if a corporation, partnership, or other business entity, as is required to be registered as an individual, has completed continuing professional education relating all of the following:

(1) The prescribing, distributing, dispensing or delivery of controlled substances, as defined in this chapter.

(2) The detection and recognition of symptoms, patterns of behavior, or other characteristics of impairment and dependency resulting from the abusive or illegal use of controlled substances.

(3) The risks of using opioids and effective alternatives to the use of opioids.

(4) Other topics as the Secretary deems appropriate.

Legislative History

16 Del. C. 1953, § 4732; 58 Del. Laws, c. 424, § 1 ; 65 Del. Laws, c. 501, §§ 1, 2 ; 70 Del. Laws, c. 186, § 1 ; 71 Del. Laws, c. 288, § 7 ; 79 Del. Laws, c. 164, § 1 ; 79 Del. Laws, c. 193, § 3 ; 81 Del. Laws, c. 430, § 1 ; 84 Del. Laws, c. 378, § 1