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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJuly 2016

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Regulatory Flexibility Act Form

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Pursuant to 16 Del.C. §4731, the Delaware Secretary of State ("Secretary") proposes revisions to the Uniform Controlled Substance Act ("UCSA") rules and regulations.
On July 1, 2015, proposed revisions to the rules and regulations were published in the Delaware Register of Regulations, Vol. 19, Issue 1. Specifically, Section 9.0 was added to provide requirements for the prescribing of opiates in order to address potential prescription drug overdose, abuse and diversion. A public hearing was held on July 29, 2015 before the Controlled Substance Advisory Committee ("Committee"). The Committee deliberated on the evidence presented at its meeting on September 23, 2015 and recommended certain revisions to the Secretary. The Secretary considered both the evidence presented and the Committee's recommendations.
Based on that review, the Secretary struck the version of Section 9.0 published in the Register of Regulations on July 1, 2015 and proposed a revised Section 9.0, which was published in the Delaware Register of Regulations on May 1, 2016, Volume 19, Issue 11. The Secretary solicited written comments from the public regarding the proposed rules and regulations allowing the period of time for such submissions to remain open for the 30 days mandated by 29 Del.C. § 10118(a).
Exhibit 1: May 12, 2016 email from David Allen
Exhibit 2: May 12, 2016 email from Mary Reppy, PhD, President & CEO Abacalab, Inc.
Exhibit 3: May 12, 2016 email from Kerry McElwee
Exhibit 4: May 12, 2015 email from Lisa Vandercook
Exhibit 5: May 12, 2016 email from Kim Allen
Exhibit 6: May 12, 2016 email from Clara Zahradnick
Exhibit 7: May 18, 2016 email from Donna Monroe, M.S.
Exhibit 8: May 24, 2016 email from Timothy Langan, M.D., Medical Director, Vitas Healthcare - Delaware.
Exhibit 9: May 24, 2016 and May 26, 2016 emails from Sally Matthews
Exhibit 10: May 25, 2016 email from Laura Wharton, B.S., Administrative Assistant Tova Community Health, Inc.
Exhibit 11: May 25, 2016 comments from John Goodill, M.D., Director, Palliative Care Education and Outreach, CCHS
Exhibit 12: May 26, 2016 comments from Jeanne Chiquoine, Delaware Government Relations Director, American Cancer Society Action Network
Exhibit 13: May 12, 2016 letter from John Becher, D.O. (President, American Osteopathic Association) and Anne Marie Sullivan, D.O. (President, Delaware State Osteopathic Medical Society)
Exhibit 14: May 27, 2016 email from Jayshree Tailor, M.D.
Exhibit 15: May 27, 2016 email from Taihitia Watson-Wilmer, LPN, Tova Community Health, Inc.
Exhibit 16: May 27, 2016 email from Dr. Nina Anderson, Nova Community Health, Inc. Sickle Cell Specialty Center
Exhibit 17: May 30, 2016 email from M. Northrop
Exhibit 18: May 30, 2016 comments from Janet Kramer, M.D.
Exhibit 19: May 30, 2016 comments from Ron Dozier
Exhibit 20: May 31, 2016 letter from Wayne A. Smith, President and CEO, Delaware Healthcare Association
Exhibit 21: May 31, 2016 comments from Brent R. King, M.D., Enterprise Vice President, Chief Medical Officer, Physician in Chief, Nemours
Exhibit 22: May 31, 2016 comments from Christopher D. Casscells, MD, Casscells Orthopaedics and Sports Medicine
Exhibit 23: May 30, 2016 fax from Dotti Dunham
Exhibit 24: May 31, 2016 letter from Attorney General Matthew Denn
Exhibit 25: May 31, 2016 letter from Adam Raben, MD, President, Delaware Society for Clinical Oncology, Helen F. Graham Cancer Center, CCHS
Exhibit 26: May 31, 2016 letter from Katie Duensing, J.D., Assistant Director for Legislative and Regulatory Affairs, State Pain Policy Advocacy Network, American Academy of Pain Management
Exhibit 27: May 31, 2016 letter from Dorothy Moore, M.D., President, Richard Henderson, M.D., Vice President and Randeep Kahlon, M.D., Treasurer, Medical Society of Delaware
MSD offered specific comments, including the following: In Section 4.2.3, a definition of "narcotic dependent person" is needed. Section 9.3.2 provides that acute pain "is less than 3 months in duration." Some disease or post-surgery recoveries use pain medication beyond 3 months. MSD recommended amended language to the effect that acute pain can continue for up to six months. With respect to Section 9.3.9, veterinarians, pharmacists and pharmacies should not be exempted. The term "institutional practitioner" needs clarification. In Section 9.5, the maximum supply for acute pain should be increased from 7 days to 14 days because patients are not always seen in a week post procedure. With respect to Section 9.6, "subsequent prescriptions," it is unrealistic to expect every patient to be seen in person in the office for every single refill request after procedures. MSD suggested that Section 9.6.1 be amended to state that a PMP query be mandated for prescriptions beyond 3 months from procedures, not for every refill during normal, acute recovery. MSD suggested, in Section 9.6.2, a change from "urine" drug screen to "fluid" drug screen to allow for future advances in medical technology. MSD suggested that Section 9.6.5, requiring the practitioner to schedule and undertake periodic follow up visits, may not apply to hospitalists, who care for and discharge patients with outpatient prescriptions but refer the patient back to the primary caregiver. MSD requested a change in Section 9.7.3 from "[a]dminister urine drug screens at least once every six months" to "at the prescriber's discretion but a minimum of twice a year." Section 9.7.5 is duplicative of Section 9.3.13 and should be stricken. In Section 9.7.7, the word "each" should be deleted, with respect to documenting other forms of treatment tried by the patient. Section 9.8, pertaining to "medical records" is unnecessary and should be deleted. The exemption for hospice and cancer patients should be put back into the regulations to avoid increased patient suffering.
Exhibit 28: May 23, 2016 letter from Robert Winter, M.D. and Arlen D. Stone, M.D., Go Care at Abby Medical, Abby Family Practice
Exhibit 29: May 31, 2016 letter from Tabassum Salam, MD, FACP, Governor, Delaware Chapter of the American College of Physicians, Senior Physician Advisor for Population Health, CCHS
Exhibit 30: May 31, 2016 email from Donna Gregory Burch
Exhibit 31: May 31, 2016 email from Hadassah Futrell
Exhibit 32: May 28, 2016 letter from Richard Bounds, M.D., John Powell, M.D. and Jonathan McGhee, D.O., Delaware ACEP (American College of Emergency Physicians)
Pursuant to 16 Del.C. §4731(a), the Secretary has the statutory authority to promulgate rules and regulations relating to the registration and control of the manufacture, distribution and dispensing of controlled substances within this State.
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.
4.2.3 A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person engaged in substance abuse or misuse, as defined in subsections 9.3.11 and 9.3.12, for the purpose of continuing his such person’s dependence upon such drugs, unless otherwise authorized by law.
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.
7.1 Security
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:
910.0 Procedures for Adoption of Regulations
910.1 Notice. Prior to the adoption, amendment or repeal of any of these controlled substances regulations, the Secretary of State/Committee will give at least twenty (20) days notice of the intended action.
910.1.1 The notice will include a statement of either the terms of substance of the intended action or a description of the subjects and issues involved, or the time when, and the place where to present their views thereon. The notice will be mailed to persons who have made timely request of the Office of Controlled Substances for advance notice of such rule-making proceedings and shall be published in two newspapers of general circulation in this State.
910.2 Hearing. The Secretary of State shall designate the Committee to preside over hearings. The Committee will afford all interested persons a reasonable opportunity to submit data, views or arguments, orally or in writing.
910.3 Emergency Regulations. If the Secretary of State, upon the recommendation of the Committee, finds that an imminent peril to the public health, safety or welfare requires adoption of a regulation upon fewer then twenty (20) days notice and states in writing his/her reasons for that finding, the Secretary of State may proceed without prior notice or hearing or upon any abbreviated notice and hearing he/she finds practicable, to adopt an emergency regulation. Such rules will be effective for a period not longer than 120 days, but the adoption of an identical rule under the procedures discussed above is not precluded.
910.4 Finding and Availability. The Secretary of State will maintain on file any adoption, amendment or repeal of these regulations. In addition, copies of these regulations will be available for public inspection at the Office of Controlled Substances.
101.0 Severability
101.1 If any provision of these regulations is held invalid the invalidity does not affect other provisions of the regulations which can be given effect without the invalid provisions or application, and to this end the provisions of the regulation are severable.
101.2 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:
101.2.1 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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