TITLE 16

Health and Safety

Food and Drugs

CHAPTER 47. UNIFORM CONTROLLED SUBSTANCES ACT

Subchapter III. Regulation of Manufacture, Distribution and Dispensing of Controlled Substances


(a) The Secretary may promulgate rules and charge reasonable fees relating to the registration and control of the manufacture, distribution and dispensing of controlled substances within this State.

(b) The Secretary shall appoint a council to act in an advisory capacity to the Secretary and other state agencies on all matters relating to this chapter. The advisory council shall be named the Controlled Substance Advisory Committee and may serve as the Secretary's designee in any hearing under this chapter.

16 Del. C. 1953, § 4731; 58 Del. Laws, c. 424, § 1; 79 Del. Laws, c. 164, § 1.;

(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.

(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 to:

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

(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; and

(3) 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.;

(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.

(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.;

(a) A registration under § 4733 of this title may be denied, suspended or revoked by the Secretary upon a finding that the registrant's DEA registration or underlying practitioner license has been suspended or revoked, or the registrant has failed to comply with any mandatory continuing education requirements established by the Secretary's rules.

(b) Before denying, suspending or revoking a registration, the Secretary shall serve upon the applicant or registrant an order to show cause why registration should not be denied, suspended or revoked. The order to show cause shall contain a statement of the basis therefore and shall call upon the applicant or registrant to appear before the Secretary at a time and place not more than 30 days after the date of service of the order. Proceedings to refuse renewal of registration shall not abate the existing registration which shall remain in effect pending the outcome of the administrative hearing.

16 Del. C. 1953, §§ 4734, 4735; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 4; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 88, § 9; 79 Del. Laws, c. 164, § 1.;

(a) All complaints shall be received and investigated by the Division of Professional Regulation in accordance with § 8735 of Title 29, and the Division of Professional Regulation shall be responsible for issuing a final written report at the conclusion of its investigation.

(b) The Secretary, after due notice and hearing may limit, suspend, fine or revoke the registration of any registrant who:

(1) Has failed to maintain effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels;

(2) Has failed to comply with applicable federal, state or local law;

(3) Has been convicted under any federal or state law relating to any controlled substances;

(4) Has furnished any false or fraudulent material in any application filed under this chapter;

(5) Has had any federal registration to manufacture, distribute, prescribe, dispense or research controlled substances as authorized by federal law suspended or revoked;

(6) Has violated a provision of this chapter, or violated an order or rule of the Secretary related to controlled substances;

(7) Has been disciplined by a professional licensing board in any jurisdiction; or

(8) Has engaged in any conduct the Secretary finds to be relevant and inconsistent with the public interest.

(c) The Secretary may limit revocation or suspension of a registration to particular controlled substances.

(d) The Secretary may fine any registrant in an amount not to exceed $1,000 per violation of this chapter or the rules promulgated hereunder.

(e) If the Secretary suspends or revokes a registration, all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may 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 therefore 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 controlled substances may be forfeited to the State.

(f) The Secretary shall promptly notify the Administration of all orders suspending or revoking registration and all forfeitures of controlled substances.

16 Del. C. 1953, § 4735; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 164, § 1.;

(a) Any registrant complained against under this chapter may appear personally or by counsel at the hearing and produce any competent evidence on the registrant's behalf in answer to the complaint. Hearings shall be conducted in accordance with the Administrative Procedures Act [Chapter 101 of Title 29]. The Secretary shall be authorized to administer oaths, examine witnesses and issue notices of hearings or subpoenas requiring the testimony of witnesses and the production of books, records or other documents relevant to any matter involved in such hearing, and subpoenas shall also be issued at the request of the applicant or person complained against. In case of contumacy or refusal to obey a notice of hearing or subpoena under this section, the Superior Court in the county in which the hearing is held shall have jurisdiction, upon application of the Secretary to issue an order requiring such person to appear and testify or produce evidence as the case may require.

(b) Any registrant aggrieved by a decision of the Secretary to deny, suspend, limit, revoke or refuse to renew registration under this chapter may appeal such decision to Superior Court. Such appeal shall be governed by the Administrative Procedures Act. When notified of an appeal under this section, the Secretary shall forward to Superior Court a certified and complete copy of the written transcripts of evidence adduced at the hearing before the Secretary together with a written copy of the Secretary's findings and rulings and the Secretary's reasons therefor.

16 Del. C. 1953, § 4735; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1; 79 Del. Laws, c. 164, § 1.;

(a) In the event of a formal or informal complaint concerning the activity of a registrant that alleges an imminent danger to the public health, safety or welfare, the Secretary may temporarily suspend any registration, pending a hearing, by written order. An order temporarily suspending a registration may not be issued unless the registrant or the registrant's attorney received at least 24 hours' written or oral notice before the temporary suspension so that the registrant or the registrant's attorney may file a written response to the proposed suspension. The decision as to whether to issue the temporary order of suspension will be decided on the written submissions. An order of temporary suspension pending a hearing may remain in effect for no longer than 60 days from the date of the issuance of the order unless the temporarily suspended registrant requests a continuance of the hearing date. If the temporarily suspended registrant requests a continuance, the order of temporary suspension remains in effect until the conclusion of all proceedings.

(b) A registrant whose registration has been temporarily suspended pursuant to this section must be notified of the temporary suspension immediately and in writing. Notification consists of a copy of the complaint and the order of temporary suspension pending a hearing personally served upon the registrant or registrant's counsel or sent by certified mail, return receipt requested, to the registrant's last known address. The Secretary will hold a hearing on the complaint giving rise to the temporary suspension within 60 days of the date of the issuance of the order of temporary suspension.

(c) A registrant whose registration has been temporarily suspended pursuant to this section may request an expedited hearing. The Secretary shall schedule the hearing within 15 days of receipt of any expedited hearing request, provided that the request is received within 5 calendar days from the date the registrant received notification of the decision to temporarily suspend the registration.

79 Del. Laws, c. 164, § 1.;

(a) Persons registered to prescribe, 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 and state law and with any rules the Secretary issues.

(b) Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an order form. Compliance with federal law respecting order forms shall be deemed compliance with this section.

16 Del. C. 1953, §§ 4736, 4737; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5; 79 Del. Laws, c. 164, § 1.;

(a) 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.

(b) In emergency situations, as defined by rule of the Secretary, Schedule II drugs may be dispensed upon oral prescription of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of this chapter. No prescription for a Schedule II substance may be refilled.

(c) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included in Schedule 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 6 months after the date thereof or be refilled more than 5 times, unless renewed by the practitioner.

(d) A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.

16 Del. C. 1953, § 4738; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5; 79 Del. Laws, c. 164, § 1.;

(a) 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.

(b) In emergency situations, as defined by rule of the Secretary, Schedule II drugs may be dispensed upon oral prescription of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of this chapter. No prescription for a Schedule II substance may be refilled.

(c) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included in Schedule 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 6 months after the date thereof or be refilled more than 5 times, unless renewed by the practitioner.

(d) A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.

(e) An ultimate user shall be permitted to prohibit or limit a person other than the ultimate user from receiving a prescription on the ultimate user's behalf from a pharmacy.

16 Del. C. 1953, § 4738; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5; 79 Del. Laws, c. 164, § 1; 79 Del. Laws, c. 409, § 1.;

Except for pharmacies and persons licensed, registered, or otherwise authorized to conduct research, no practitioner shall dispense controlled substances beyond the amount deemed medically necessary for a 72-hour supply.

79 Del. Laws, c. 92, § 2.;

(a) Beginning January 1, 2014, before completing a sale of an over-the-counter material, compound, mixture, or preparation containing any detectable quantity of pseudoephedrine or ephedrine, its salts or optical isomers, or salts of optical isomers a pharmacy or retailer shall electronically submit the information required pursuant to subsection (b) of this section to the National Precursor Log Exchange system ("NPLEx'') administered by the National Association of Drug Diversion Investigators; provided that the National Precursor Log Exchange is available to pharmacies or retailers in the State without a charge for accessing the system. The pharmacy or retailer shall not complete the sale if the NPLEx system generates a stop sale alert. The system shall contain an override function that may be used by an agent of a retail establishment who is dispensing the drug product and who has a reasonable fear of imminent bodily harm if the transaction is not completed. The system shall create a record of each use of the override mechanism.

(b) The pharmacy or retailer shall maintain a written or electronic log of required information for each sale of a nonprescription product containing pseudoephedrine or ephedrine, including:

(1) The date and time of any transaction;

(2) The name, address, and date of birth of the person purchasing or obtaining the substance;

(3) The type of government-issued identification provided by the person purchasing or obtaining the substance and identification number;

(4) The government agency issuing the identification used; and

(5) The name of the compound, mixture, or preparation and the amount.

The pharmacy or retailer shall require every person purchasing or obtaining the substance to sign a written or electronic log attesting to the validity of the information.

(c) If a pharmacy or retailer selling an over-the-counter product containing the substance experiences mechanical or electronic failure of the electronic tracking system and is unable to comply with the electronic sales tracking requirement under this section, the pharmacy or retailer shall maintain a written log or an alternative electronic record keeping mechanism until such time as the pharmacy or retailer is able to comply with the electronic sales tracking requirement.

(d) Any material, compound, mixture, or preparation as defined in subsection (a) of this section shall be dispensed, offered for sale, sold, or distributed only from behind a checkout counter, pharmacy counter, or in a locked storage container where the public is not permitted.

(e) A licensed pharmacist, sales clerk, or pharmacy technician shall require that any person purchasing, receiving, or otherwise acquiring any such substance shall be age 18 or older, produce a photo identification showing the date of birth of the person, and sign a written log or receipt showing the date of the transaction, name of the person, and the amount of such substance. The written log or electronic log shall be retained for at least 12 months.

(f) No person, other than pharmacy or retail establishment, shall purchase, receive, or otherwise acquire more than 9 grams of any such substance within any 30-day period.

(g) A violation of this section is a class A misdemeanor.

(h) The National Association of Drug Diversion Investigators shall forward Delaware transaction records in the NPLEx to the Drug Diversion Unit of the Delaware State Police weekly and provide real-time access to the NPLEx information through the NPLEx online portal to law enforcement in the State as authorized by the State Police; provided that the State Police execute a memorandum of understanding with the National Association of Drug Diversion Investigators governing access to the information; provided further that the State Police shall establish the electronic tracking system in conjunction with the State's existing narcotics tracking system no later than January 1, 2014.

75 Del. Laws, c. 52, § 1; 75 Del. Laws, c. 217, § 1; 77 Del. Laws, c. 334, § 1; 79 Del. Laws, c. 175, § 1.;