Delaware Code Title 16 Sec. 4733 – Registration; rights of registrants
(a) The Secretary shall register an applicant as a pharmacy, distributor, manufacturer, practitioner, researcher or other controlled substance registrant for purposes of manufacturing, distributing or dispensing, some or all of the controlled substances included in Schedules I-V who has an active, relevant underlying professional license in the State unless the Secretary determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the Secretary shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels;
(2) Compliance with applicable federal, state and local law, including but not limited to such requirements as having a license to practice as a practitioner or having documented training and continuing education as a drug detection animal trainer;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant’s establishment of effective controls against diversion;
(5) Furnishing by the applicant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the applicant’s federal registration to manufacture, distribute, prescribe, dispense or research controlled substances as authorized by federal law;
(7) Any professional license disciplined in any jurisdiction; and
(8) Any other factors relevant to the public interest.
Terms Used In Delaware Code Title 16 Sec. 4733
- controlled substance: includes "designer drug" as defined in paragraph (10) of this section. See Delaware Code Title 16 Sec. 4701
- Dispense: means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing for a legitimate medical purpose by an individual practitioner in the usual course of the practitioner's professional practice, administering, packaging, labeling or compounding necessary to prepare the substance for that delivery. See Delaware Code Title 16 Sec. 4701
- Distribute: means to deliver other than by administering or dispensing a controlled substance. See Delaware Code Title 16 Sec. 4701
- Distributor: means a person who distributes. See Delaware Code Title 16 Sec. 4701
- Drug: means (i) substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary or any supplement to any of them; (ii) substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; (iii) substances (other than food) intended to affect the structure or any function of the body of man or animals; and (iv) substances intended for use as a component of any article specified in clause (i), (ii) or (iii) of this paragraph. 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.
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- Manufacture: means the production, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of its container except that this term does not include the preparation or compounding of a controlled substance by an individual for the individual's own use or the preparation, compounding, packaging or labeling of a controlled substance:
- Practitioner: means :
- Prescribe: means to give an order for medication or other therapy by authorized personnel which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. See Delaware Code Title 16 Sec. 4701
- 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
(b) Registration under subsection (a) does not entitle a registrant to manufacture, research and distribute controlled substances in Schedule I or II other than those specified in the registration.
(c) 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 this State. The Secretary need not require separate registration under this subchapter for practitioners engaging in research with nonnarcotic 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 this State upon furnishing the Secretary evidence of that federal registration.
(d) Compliance by manufacturers and distributors with the federal law respecting registration (excluding fees) entitles them to be registered under this chapter.
16 Del. C. 1953, § ?4733; 58 Del. Laws, c. 424, § ?1; 70 Del. Laws, c. 186, § ?1; 71 Del. Laws, c. 288, § ?8; 79 Del. Laws, c. 164, § ?1;