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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsFebruary 2017

Regulatory Flexibility Act Form

Authenticated PDF Version

Pursuant to 16 Del.C. §4731(a), the Delaware Secretary of State ("Secretary") proposes revisions to the Uniform Controlled Substance Act ("UCSA") rules and regulations. The proposed regulation is attached hereto as Exhibit A.
In addition, on December 15, 2016, the Secretary issued a Final Order adopting emergency regulations adding the synthetic opioid known as U-47700 to Schedule I. This Final Order was published in the Delaware Register of Regulations on January 1, 2017, Volume 20, Issue 7. Pursuant to the Administrative Procedure Act, the Secretary's Final Order will only be effective for a maximum of 120 days but may be renewed once for an additional period of sixty days. 29 Del.C. §10119(3). Therefore, the Secretary has proposed the addition of subsections 10.3.1 and to the UCSA rules and regulations.
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.
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.
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.
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.
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:
9.6 Subsequent prescriptions. Subject to the exemptions set forth in subsection 9.7, Aafter the first time outpatient prescription, or after the patient has been issued outpatient prescription(s) totaling up to a seven day supply, prior to issuing a subsequent prescription for an opioid analgesic for Acute Pain, the practitioner must perform an appropriate evaluation of the patient's medical history and condition, including the following:
9.78 Chronic Pain patients. In addition to the requirements of subsection 9.6, the practitioner must adhere to the following additional requirements for Chronic Pain patients:
9.78.1 Query the PMP at least every six months, more frequently if clinically indicated, or whenever the patient is also being prescribed a benzodiazepine;
9.78.2 Query the PMP whenever the patient is assessed to potentially be at risk for substance abuse or misuse or demonstrates such things as loss of prescription(s), requests for early refills or similar behavior;
9.78.3 Administer fluid drug screens at least once every six months;
9.78.4 Obtain a signed Treatment Agreement, pursuant to subsection 9.3.13;
9.78.5 Conduct a Risk Assessment as defined in subsection 9.3.10;
9.78.6 Document in the patient's medical record alternative treatment options that have been tried by the patient, including non-pharmacological treatments, and their adequacy with respect to providing sufficient management of pain;
9.78.7 Make efforts to address psychiatric and medical comorbidities concurrently, rather than sequentially, when concurrent treatment is clinically feasible; and
9.78.8 At the practitioner's discretion, seek a case review and consult with, or otherwise refer the patient to, a state-licensed physician who holds a subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology or an addiction certification from the American Board of Addiction Medicine or an addiction specialist if any of the following occur: Adulterated drug tests; Diversion of prescribed medications; or The patient has obtained controlled substances elsewhere without disclosure to the physician, as evidenced by PMP data.
9.89 Practitioners treating the following patients are exempted from the requirements of this Regulation:
9.89.1 Hospice care patients;
9.89.2 Active cancer treatment patients;
9.89.3 Patients experiencing cancer-related pain;
9.89.4 Terminally ill/palliative care patients; and
9.89.5 Hospital patients, during the hospital stay, including any prescription issued at the time of discharge, so long as that discharge prescription is for a quantity of a 7-day supply or less.
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: 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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