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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsAugust 2016

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After due notice in the Delaware Register of Regulations and two Delaware newspapers, a public hearing was held on April 27, 2016 at a scheduled meeting of the Delaware Controlled Substance Advisory Committee (“Committee”) to receive comments regarding proposed amendments to the Uniform Controlled Substances Act rules and regulations. The proposed revisions address the photo identification requirement for picking up a controlled substance prescription at a pharmacy. Specifically, Section 4.10.1 is amended to specify that both Federal and military identification are acceptable. A new Section 4.10.1.5 provides an exemption to the photo identification requirements, but only for a patient at an inpatient facility.
The proposed changes to the rules and regulations were published in the Register of Regulations, Volume 19, Issue 9, on March 1, 2016. Notice of the April 27, 2016 hearing was published in the News Journal (Exhibit 1) and the Delaware State News. Exhibit 2. Pursuant to 29 Del.C. § 10118(a), the date to receive final written comments was May 12, 2016, 15 days following the public hearing. The Committee deliberated on the proposed revisions at its regularly scheduled meeting on June 22, 2016.
Commission Exhibit 1: News Journal Affidavit of Publication.
Commission Exhibit 2: Delaware State News Affidavit of Publication.
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.
The Secretary of State finds that these changes are in the best interest of the public and hereby accepts the proposed rules and regulations as set forth in the Delaware Register of Regulations on March 1, 2016, to be effective 10 days following publication of this order in the Register of Regulations. The revised rules and regulations are attached hereto as Exhibit A.
IT IS SO ORDERED this 11th day of July, 2016.
SECRETARY OF STATE
Jeffrey W. Bullock
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.
4.10.1.2 A valid Delaware or Federal, including military, identification card which contains the photograph of the person receiving the prescription - record the identification number listed on the card as part of the patient record.
5.1 All dispensed prescriptions including samples shall be labeled in compliance with 24 Del.C. §2522.
5.3 Practitioners who sell drugs directly to patients shall label all such drugs in accordance with Regulation subsection 5.2 with the exception of a prescription number.
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 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 than 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.
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.
Last Updated: December 31 1969 19:00:00.
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