Source: http://regulations.delaware.gov/register/november2011/emergency/15%20DE%20Reg%20577%2011-01-11.htm
Timestamp: 2018-08-16 10:40:16
Document Index: 8694045

Matched Legal Cases: ['§4713', '§4714', '§ 4700', '§4786', '§4732', '§4732', '§4713', '§4713']

Emergency Rule Adoption Placing Mephedrone, Methylone, and MDPV In Schedule I
WHEREAS, the Secretary of the Department of State ("the Secretary") has been charged by the Delaware legislature with placing substances in Schedule I if the Secretary finds that the substances: (1) have high potential for abuse; and (2) have no accepted medical use in treatment in the United States or lack accepted safety for use in treatment under medical supervision. 16 Del.C. §4713; and
WHEREAS, available data and information for mephedrone, methylone, and methylenedioxypyrovalerone (MDPV) indicate that these three synthetic cathinones have a high potential for abuse, no currently accepted medical use in treatment in the United States and lack accepted safety for use under medical supervision; and
WHEREAS, these three synthetic cathinones are not currently listed in any schedule under Delaware law; and
WHEREAS, on September 8, 2011 the Drug Enforcement Agency published in the Federal Register an emergency notice, temporarily placing these three synthetic cathinones in Schedule I for a twelve month period effective October 8, 2011 finding that these three synthetic cathinones have a high potential for abuse, no currently accepted medical use in treatment in the United States and lack accepted safety for use under medical supervision; and
WHEREAS, the Delaware Controlled Substance Advisory Committee has recommended the enactment of an emergency regulation placing these three substances in Schedule I; and
WHEREAS, the Secretary finds that adoption of a regulation placing these three synthetic cathinones temporarily in Schedule I under Delaware law must occur on an emergency basis in order to properly protect the public until such time as the legislature may reconvene to adopt a statutory amendment to 16 Del.C. §4714; and
WHEREAS, the Secretary will accept, consider and respond to petitions by any interested person for the reconsideration or revision of this regulation by addressing the same to the attention of Mr. Dave Dryden, Cannon Building, 861 Silver Lake Blvd., Dover, DE 19904; and
NOW, THEREFORE, IT IS ORDERED this 30th day of September, 2011.
SO ORDERED this 30th day of September, 2011.
1.1	The Controlled Substance Advisory Committee (hereafter designated as "the Committee") has a primary objective to promote, preserve and protect the public health, safety and welfare by regulating and monitoring controlled substance use and abuse through a program of registration, inspection, investigation and education. The Committee regulates by registering prescribers, dispensers, manufactures, distributors, clinics, researchers and other controlled substance registrants (i.e. – dog handler). Among its functions, the Committee issues and renews licenses; and makes recommendations to the Secretary of State of new or amended controlled substance regulations and disciplinary actions of registrants who violate the law. (16 Del.C. § 4700 to the end)
1.3	Each Committee member shall serve a term of three years and may succeed themselves for one additional term. A Committee member whose appointment has expired remains eligible to participate in Committee proceedings unless replaced by their respective regulatory board.
1.6	The Drug Control Administrator for the Division of Professional Regulation, who is an ex officio member of the Committee without a vote, is responsible for the performance of the regular administrative functions of the Committee and other duties as the Committee may direct.
2.2.3	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 therefore, and forward them to the persons 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.
4.2.2	A verbal prescription for a controlled substance may only be communicated to a pharmacist or pharmacy intern by the prescriber. Prescriptions for controlled substances communicated by an employee or agent of the prescriber are not valid.
4.2.3	Written prescriptions for controlled substances may be transmitted via facsimile by a practitioner or by the practitioner’s authorized agent to a pharmacy only when the transmission complies with 21 CFR 1306.11, 1306.21 and 1306.31.
4.4	Manner of Issuance of Prescriptions. All prescriptions for controlled substances shall be dated and signed on the day when issued and shall bear the full name and address of the patient, and the name, address, telephone number and registration number of the practitioner. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (e.g. J.H. Smith or John H. Smith). When an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner but the prescribing practitioner is responsible where the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations. Each written prescription shall have the name of the practitioner stamped, typed, or hand-printed on it, as well as the signature of the practitioner.
4.8.1	Prescriptions for controlled substances in Schedules II and III will become void unless dispensed within seven (7) days of the original date of the prescription or unless the original prescriber authorizes the prescription past the seven (7) day period. Such prescriptions cannot be written nor dispensed for more than 100 dosage units or a 31 day supply whatever is the greater at one time. As an exception to dosage limitations set forth in this subparagraph, and in accordance with 21 CFR Section 1306.1(b), prescriptions for controlled substances in Schedule II for patients either having a medically documented terminal illness or patients in Long Term Care Facilities (LTCF), may be filled in partial quantities, to include individual dosage units. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed.
4.10	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. Pharmacists may dispense controlled substances pursuant to a prescription written by a non-resident practitioner (who is not registered under 16 Del.C. Ch. 47) provided that:
4.10.1	The pharmacist must establish that the non-resident practitioner is properly registered to prescribe controlled substances under Federal Law. The pharmacist may keep a record which contains the name and address of the non-resident practitioner, his Federal registration number, and the name and address of the source of the registration data.
4.10.2	The pharmacist and/or an employee under his/her direct supervision must verify the identification of the bearer and receiver of the controlled substance prescription by reference to valid photographic identification and record the unique number associated with the valid photographic identification as part of the prescription record. For the purposes of this section, a valid photographic identification is limited to the following:
4.10.2.1	A valid Delaware motor vehicle operator's license which contains a photograph of the person presenting the prescription - record the license number listed on the license as part of the prescription record.
4.10.2.2	A valid Delaware identification card which contains the photograph of the person presenting the prescription - record the identification number listed on the card as part of the prescription record.
4.10.2.3	A valid United States passport.
4.10.2.4	A valid passport or motor vehicle operator's license or state identification card of another state, territory or possession of the United States or a foreign country only if it:
4.10.2.4.1	Contains a photograph of the person presenting the prescription:
4.10.2.4.2	Is encased in tamper-resistant plastic or is otherwise tamper-resistant.
4.10.2.4.3	Identifies the date of birth of the person presenting the prescription and has an identification number assigned to the document which can be recorded as part of the prescription record.
4.10.3	The pharmacist must establish that the name of the non-resident practitioner does not appear on the list kept by the Office of Controlled Substances of those non-resident practitioners to whom the waiver granted by this regulation does not apply.
4.10.3.1	The waiver of the registration requirement provided by the registration shall not apply to non-resident practitioners determined by the Office of Controlled Substances to have acted in a manner inconsistent with the Public Health and Safety. The Office of Controlled Substances shall maintain a list of those non-resident practitioners found by them to have so acted. Pharmacists shall not honor the prescriptions of non-resident practitioners whose names appear on that list unless such non-resident practitioners have registered pursuant to the provisions of 16 Del.C. §4732.
4.12	The pharmacist and/or an employee under his/her supervision must also verify the identity of the person receiving a dispensed controlled substance at the time it is transferred to that person. The manner in which valid photographic identification is verified and recorded shall be the same as provided in 4.10.2.
5.1.1.4	Controlled substances listed in Schedules III, IV and V shall be stored in a securely locked, substantially constructed cabinet. Pharmacies may disperse such substances in Schedule III, IV and V throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances. The immediate area in a pharmacy containing dispersed, controlled drugs must be secured in a manner approved by the Office of Controlled Substances which will prevent entry by unauthorized persons. The keys to such area shall at all times be carried by a pharmacist. The doors shall be locked whenever the area is not directly under the supervision of a pharmacist or a responsible person designated by the pharmacist.
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, the place where 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.
7.1	If any provision of these regulations is held invalid the invalidity does not effect 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.
7.3	Pursuant to 16 Del.C. §4713 the Secretary of State finds that mephedrone, methylone, and methylenedioxypyrovalerone (MDPV) have high potential for abuse; have no accepted medical use in treatment in the United States or lack accepted safety for use in treatment under medical supervision, and therefore:
7.3.1	The Secretary of State, as authorized by 16 Del.C. §4713 does hereby add by rule mephedrone, methylone, and methylenedioxypyrovalerone (MDPV) in Schedule I of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
15 DE Reg. 577 (11/01/11) (Emergency)