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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMarch 2018


Regulatory Flexibility Act Form

Authenticated PDF Version

Pursuant to 16 Del.C. §4731, the Delaware Controlled Substance Advisory Committee ("Committee") has proposed revisions to its rules and regulations. Section 1.0 addresses the composition and operation of the Committee. This Section has been revised to state that Committee members may serve up to three terms of three years each. Further proposed changes specify that Committee officers may serve for up to two one year terms, and all Committee members are appointed by the Secretary of State. Subsection 1.7, pertaining to quorum, currently provides that in disciplinary matters, at least one member of the quorum must be from the same profession as the practitioner who is the subject of the proceeding. This requirement can pose significant difficulties in hearing disciplinary matters in the event that a Committee member has a conflict requiring recusal. In that scenario, the Committee may be precluded from taking action with the result that a registrant who has violated laws and regulations pertaining to controlled substances may be insulated from discipline. The Committee has proposed that Section 1.7 be revised to remove this problematic language.
1.3 Each Committee member shall serve a term of three years and may succeed themselves for one additional term A member of the Committee may not serve more than 3 full, consecutive 3-year terms, which is not diminished by serving an unexpired term. Upon serving 3 full, consecutive 3-year terms, a former member is eligible for reappointment to the Committee no earlier than 1 year after the expiration of the last term served on the Committee by the former member. A Committee member whose appointment has expired remains eligible to participate in Committee proceedings unless until replaced.
1.5 The conduct of all hearings and issuance of orders shall be in accordance with the procedures established pursuant to this section, Chapter 101 of Title 29, section 8735 of Title 29, and sections 4731 through 4736 of Title 16.
1.6 The Drug Control Administrator for the Division of Professional Regulation is responsible for the performance of the regular administrative functions of the Committee and other duties as the Committee may direct.
1.7 A majority of members shall constitute a quorum, and no action shall be taken without the affirmative vote of at least 5 members. For proceedings involving the denial, suspension or revocation of a controlled substance registration at least 1 member of the quorum must be from the same profession as the practitioner whose registration is the subject of the proceeding. Any member who fails to attend 3 consecutive meetings, or who fails to attend at least half of all regular business meetings during any calendar year, shall automatically upon such occurrence be deemed to have resigned from office and a replacement shall be appointed by the Secretary of State A majority of the members shall constitute a quorum for the purpose of transacting business and no action shall be taken without the affirmative vote of a majority of the quorum. No disciplinary action may be recommended to the Secretary without the affirmative vote of a majority of the members of the Committee.
1.81.9 Minutes of all meetings shall be maintained by the Division of Professional Regulation. A record from which a verbatim transcript can be prepared shall be made of all hearings where evidence is presented. The expense of preparing any transcript shall be borne by the person requesting it.
Act” means the Controlled Substance Act, 16 Del.C. Ch. 47.
Administer” or “administration” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion or any other means. The administration of a drug directly to a patient by a practitioner is administration not an act of dispensing.
Controlled substance” means any substance or drug defined, enumerated or included in this chapter and Title 21, Code of Federal Regulations.
Direct supervision” means the supervising practitioner, pharmacist or licensee will be present and immediately available within the dispensing area.
Dispense” or “dispensing” means the interpretation, evaluation, and implementation of a prescription drug or, including the preparation and delivery of a drug to a patient or patient’s agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
Dispenser” means a person authorized by this State to dispense or distribute to the ultimate user any controlled substance.
Pharmacist” means any pharmacist licensed by the State of Delaware to dispense controlled substances and shall include any other person (e.g. pharmacist intern) authorized by the State of Delaware to prescribe, dispense or store controlled substances under the supervision of a pharmacist licensed by this State.
Practitioner” means physician, dentist, veterinarian, podiatrist, nurse practitioner, physician assistant or other individual, licensed, registered, or otherwise permitted, by the United States or the State of Delaware to prescribe, dispense or store a controlled substance in the course of professional practice but does not include a pharmacist, a pharmacy, or an institutional practitioner.
Prescription” means an order for medication 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. (e.g. an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)
Register” and “registered” refer to registration required by 16 Del.C. §4732.
3.3.2 Proceedings for denying, suspending or revoking a registration shall be held before the Committee. The Committee will forward their recommendation in writing to the Secretary of State for his/her review and decision. Persons complained against may appear personally or by counsel, and may produce any competent evidence in their behalf in answer to the alleged violation.
3.3.3 Whenever a registration is denied, suspended, or revoked by the Secretary of State, the Secretary of State or his/her designee will reduce in writing his/her findings and rulings, and the reasons therefor, and forward them to the persons applying for registration or complained against within 15 days of receiving the written recommendation of the Committee. This provision shall in no way stay any such denial, suspension, or revocation. The Secretary of State’s decision is final and conclusive. A person aggrieved may file an appeal as provided in 16 Del.C. §4786.
4.9 Pursuant to authority granted by 16 Del.C. §4732 the Secretary of State finds that waiver of the registration requirements contained in that section as to non-resident practitioners is consistent with the public health and safety subject to the conditions contained in this regulation.
5.1 All dispensed prescriptions including samples shall be labeled in compliance with 24 Del.C. §2522.
6.1.3 Other records required by 21 CFR 1300 to the end of 1316. The information for prescribed controlled substances may be kept either in a log or on patient records provided such records or logs are made available for inspection. The information for dispensed controlled substances must be maintained in a separate log. Entries must include the date dispensed, name and address of the patient, name and strength of medication, and amount dispensed.
6.3.1 Pharmacies. Whenever the pharmacist in charge of a pharmacy in the State of Delaware leaves his position, a complete inventory of all medication covered by 16 Del.C., Ch. 47 be taken by the present and prospective pharmacist-in-charge. A copy of such inventory will be sent to the Office of Controlled Substances and another copy retained on the premises.
8.3 Administrative inspections of controlled premises may be conducted in accordance with the provisions under 16 Del.C. §4782.
9.3.1 "Acute Care" means the treatment of Acute Pain, as defined in subsection 9.3.2.
9.3.2 "Acute Pain" means the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. It is generally time limited. For the purpose of this Regulation, Acute Pain is less than three months in duration.
9.3.3 "Acute pain episode" means a discrete period of pain that usually follows some sort of injury to the body and generally dissipates when the injury heals.
9.3.4 "Addiction" means a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.
9.3.5 "Chronic Care" means the treatment of Chronic Pain, as defined in subsection 9.3.6.
9.3.6 "Chronic Pain" means a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years. For the purpose of this Regulation, Chronic Pain means continuous or nearly continuous pain more than three months in duration.
9.3.7 "Opioid Analgesic" means a drug that is used to alleviate moderate to severe pain that is either an opiate (derived from the opium poppy) or opiate-like (synthetic drugs). Examples include: morphine, codeine, fentanyl, meperidine, and methadone. For purposes of this regulation, it does not include, unless specifically designated as controlled under 16 Del.C. §4711, the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). It does include its racemic and levorotatory forms.
9.3.8 "PMP" means the Delaware Prescription Monitoring Program.
9.3.9 "Practitioner" means a physician, dentist, podiatrist, nurse practitioner, physician assistant or other individual, licensed, registered, or otherwise permitted, by the United States or the State of Delaware to prescribe a controlled substance in the course of professional practice but does not include veterinarians.
9.3.10 "Risk Assessment" means utilizing a tool appropriate for the patient, such as but not limited to, the Screener and Opioid Assessment for Patients with Pain ("SOAPP"), Opioid Risk Tool ("ORT"), or Screening, Brief Intervention and Referral to Treatment ("SBIRT"), which are designed for predicting the likelihood that a patient will abuse or misuse a prescribed controlled substance based on past behavior, genetic predispositions, social or environmental factors, or other risks.
9.3.11 "Substance Abuse" means using a controlled substance without a legitimate medical need, for the purpose of altering one's emotional experience.
9.3.12 "Substance Misuse" means using a controlled substance in a way that is not prescribed.
9.3.13 "Treatment Agreement" means a written agreement, signed by the practitioner and the patient (or the patient's proxy), which shall become part of the patient's medical record. The Treatment Agreement may include, at the practitioner's discretion:
10.3.1 Pursuant to 16 Del.C. §4713 the Secretary of State finds that the synthetic opioid, 3, 4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, has high potential for abuse; has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision, and therefore:
10.3.1.1 The Secretary of State, as authorized by 16 Del.C. §4713, does hereby add by rule 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, in Schedule I of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
11.2 Pursuant to 16 Del.C. §4718(f) and 16 Del.C. §4720(c) the Secretary of State finds that the compounds, mixtures or preparations listed in 21 CFR 1301.21, 21 CFR 1308.24 contain one or more active medical ingredients not having a stimulant or depressant effect on the central nervous system and that the admixtures included therein are in combinations, quantities, proportions, or concentrations that vitiate the potential for abuse of the substances which have a stimulant or depressant effect on the central nervous system, and therefore:
11.2.1 The Secretary of State, as authorized by 16 Del.C. §4718(f) and 16 Del.C. §4720(c), does hereby except by rule the substances listed in 21 CFR 130.21, CFR 1308.24 and 21 CFR 1308.32 from Schedules III and IV of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
Last Updated: December 31 1969 19:00:00.
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