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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsAugust 2014

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WHEREAS, the Secretary of the Department of State ("the Secretary") "may promulgate rules . . . relating to the registration and control of the manufacture, distribution and dispensing of controlled substances within this State." 16 Del.C. §4731(a); and
WHEREAS, the Secretary may adopt emergency regulations if the Secretary finds that there exists an imminent peril to the public health, safety or welfare. 29 Del.C. §10119; Regulation 9.3 of the Uniform Controlled Substance Act Regulations; and
WHEREAS, available data and information pertaining to extended-release hydrocodone lacking abuse-deterrent formulation demonstrates that this medication poses imminent peril to the public, health safety and welfare in that it is approximately five times more potent than opioids currently being prescribed to treat pain. Further, the medication lacks an abuse-deterrent formulation, meaning that it can be chewed, crushed or dissolved, thereby causing rapid release and absorption of a potentially fatal dose of hydrocodone; and
WHEREAS, the Delaware Controlled Substance Advisory Committee has recommended the enactment of an emergency regulation placing limitations and requirements on the prescription of extended-release hydrocodone lacking abuse-deterrent formulation; and
WHEREAS, the Secretary finds that adoption of the recommended regulation must occur on an emergency basis in order to properly protect the public; and
WHEREAS, the Secretary will accept, consider and respond to petitions by any interested person for the reconsideration of adoption of this regulation by addressing the same to the attention of Mr. Dave Dryden, Cannon Building, 861 Silver Lake Blvd., Dover, DE 19904; and
WHEREAS, a copy of this Order will be submitted to the Registrar for publication in the next issue of the Delaware Register of Regulations;
NOW, THEREFORE, IT IS ORDERED this 18th day of June, 2014:
2. In accordance with the provisions of 29 Del.C. §10119(3), this Order shall be effective for 120 days from the date of execution.
SO ORDERED this 18th day of June, 2014.
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.
7.1 Security
8.3 Administrative inspections of controlled premises may be conducted in accordance with the provisions under 16 Del.C. §4782.
10.2 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:
10.2.1 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.
11.1 Purpose: This rule provides requirements for the prescription of extended-release hydrocodone lacking abuse-deterrent formulation in order to address potential prescription drug overdose, abuse and diversion.
"Abuse-deterrent formulations" or "ADF" means one of the following: physical/chemical barriers (i.e., physical barriers that prevent chewing, crushing, cutting, grating, or grinding or chemical barriers that can resist extraction of the opioid using common solvents like water); aversion (i.e., substances that can be combined to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or a higher dosage than directed is used); a formulation such that the drug is lacking in opioid activity until transformed in the gastrointestinal tract (known as a Prodrug); or a combination of the above methods).
"Controlled Substance Treatment Agreement" means a document that is agreed upon by both the practitioner and the patient acknowledging the rights, responsibilities and risks of being on a controlled substance and the treatment being received.
"Hydrocodone" means a semi-synthetic opioid derived from codeine.
"Misuse" means using a controlled substance in a way that is not prescribed.
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.
"Risk Assessment" means utilizing a tool, such as the Screener and Opioid Assessment for Patients with Pain (“SOAPP”), which is 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.
11.3.1 Prior to prescribing an extended-release hydrocodone that is manufactured without an ADF, the practitioner shall: Document in the medical record that the prescription of a hydrocodone without an ADF is required for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options, including non-pharmacological treatments, are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient management of pain; Receive a signed Informed Consent form from the patient, or if the patient is not competent to provide informed consent, from the patient’s legal representative, that shall include information regarding the drug’s potential for addiction, abuse, and misuse; and the risks associated with the drug of life-threatening respiratory depression; overdose as a result of accidental exposure potentially fatal, especially in children; neonatal opioid withdrawal symptoms; and potentially fatal overdose when interacting with alcohol; Receive a signed Controlled Substance Treatment Agreement from the patient that shall include requirements such as urine screening (no less frequently than every 120 days), pill counts, safe storage and disposal, and other appropriate conditions as determined by the practitioner to reasonably and timely inform the practitioner if the patient is misusing the prescribed substance; Query the Delaware Prescription Monitoring Program (“PMP”) and review other controlled substances prescribed to the patient prior to the first prescription. For any patient prescribed 40 mg or greater per day, the practitioner shall query the PMP no less frequently than once every 120 days for as long as the patient possesses a valid prescription for that amount; Determine a maximum daily dose or a "not to exceed value" for the prescription to be transmitted to the pharmacy; Write a prescription that must be filled within seven (7) days and that does not exceed 30 days in duration.
11.3.2 The practitioner shall schedule and undertake periodic follow-up visits and evaluations of the patient.
11.3.3 The practitioner shall schedule follow-up visits with the patient and at each such visit shall evaluate, determine and document:
Last Updated: December 31 1969 19:00:00.
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