Delaware Code Title 16 Sec. 4732 – Registration requirements; exemptions; inspections
(a) Any pharmacy, distributor, manufacturer, practitioner, 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.
Terms Used In Delaware Code Title 16 Sec. 4732
- Agent: means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor or dispenser. See Delaware Code Title 16 Sec. 4701
- Contract: A legal written agreement that becomes binding when signed.
- controlled substance: includes "designer drug" as defined in paragraph (10) of this section. See Delaware Code Title 16 Sec. 4701
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- delivery: means the actual, constructive or attempted transfer from one person to another of a controlled substance, whether or not there is an agency relationship. See Delaware Code Title 16 Sec. 4701
- Dispenser: means a practitioner who dispenses. See Delaware Code Title 16 Sec. 4701
- Distributor: means a person who distributes. See Delaware Code Title 16 Sec. 4701
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Licensed practitioner: means any individual who is authorized by law to prescribe drugs in the course of professional practice or research in any state. See Delaware Code Title 16 Sec. 4701
- Other controlled substance registrants: means all persons and firms, except persons or firms exempt from registration, who are not classified as pharmacies, distributors, manufacturers, practitioners or researchers. See Delaware Code Title 16 Sec. 4701
- Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
- Person: means individual, corporation, government or governmental subdivision or agency, statutory trust, business trust, estate, trust, partnership or association, or any other legal entity. See Delaware Code Title 16 Sec. 4701
- Practitioner: means :
- Researcher: means all persons and firms, not a practitioner, who routinely performs scholarly or scientific investigations or inquiries. See Delaware Code Title 16 Sec. 4701
- Secretary: means Secretary of the Department of State or the Secretary's designee in paragraph (22) of this section; §§ 4711; 4713; 4715; 4717; 4718(l); 4719; 4720(c); 4721; 4731; 4732; 4733; 4734(a) and (b); 4735 (b), (c) and (d); 4736(a) and (b); 4737; 4738; 4739(b); 4762(e)(2); 4781(1); 4782; 4783(b); 4785; 4786; 4787(b), (c), (d), (e) and 4791(d) of this title. See Delaware Code Title 16 Sec. 4701
- State: when applied to a part of the United States, includes any state, district, commonwealth, territory, insular possession thereof and any area subject to the legal authority of the United States of America. See Delaware Code Title 16 Sec. 4701
- Ultimate user: means a person who lawfully possesses a controlled substance for the person's own use or for the use of a member of the person's household or for administering to an animal owned by the person or by a member of the person's household. See Delaware Code Title 16 Sec. 4701
(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.
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;