Current through Register Vol. 28, No. 3, September 1, 2024
4.1 Persons Entitled to Issue Prescriptions
4.1.1 A prescription for a controlled substance may be issued only by a practitioner who is:
4.1.1.1 Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practiced the licensed profession; and
4.1.1.2 Either registered or exempt from registration pursuant to 16 Del.C. §
4732.
4.1.2 A verbal prescription for a controlled substance may only be communicated to a pharmacist, a pharmacy intern or a pharmacy student participating in an approved College of Pharmacy coordinated practical experience program under the direct supervision of a licensed pharmacist by the prescriber. Verbal prescriptions for schedule III-V controlled substances in a hospice or long term care facility may be communicated by an authorized agent of the prescriber.
4.1.3 All verbal prescriptions for controlled substances must be verified and authorized by the prescriber.
4.1.4 Prescriptions for controlled substances may be transmitted via facsimile or electronic transmission by a practitioner or by the practitioner's authorized agent to a pharmacy.
4.2 Purposes of Issue of Prescription
4.2.1 A prescription for a controlled substance must be issued for a legitimate medical purpose by practitioner acting in the usual course of their professional practice. The responsibility for proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription not issued in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of §4738 of the Act and the person knowingly filling such a purported prescription, as well as the person issuing it shall be subject to the penalties provided for violation of the provisions of law relating to controlled substances.
4.2.2 A prescription may not be issued in order for a practitioner to obtain controlled substances for supplying the practitioner for the purpose of general dispensing to patients.
4.2.3 A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a person engaged in substance abuse or misuse, as defined in subsections 9.3.11 and 9.3.12, for the purpose of continuing such person's dependence upon such drugs, unless otherwise authorized by law.
4.3 Manner of Issuance of Prescriptions. All prescriptions for controlled substances shall be dated 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 the practitioner 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.
4.4 Persons Entitled to fill Prescriptions. A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or by a registered institutional practitioner.
4.5 Dispensing Narcotic Drugs for Maintenance Purposes. No person shall administer or dispense narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing the person's dependence except in compliance with and as authorized by Federal law and regulation.
4.6 Emergency Dispensing of Schedule II Substances. In an emergency situation a pharmacist may dispense controlled substances listed in Schedule II upon receiving oral authorization of a prescribing practitioner, provided that the procedures comply with Federal law and regulation.
4.7 Expiration and Partial Filling of Controlled Substance Prescriptions
4.7.1 Expiration
4.7.1.1 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.
4.7.1.2 Schedule II prescriptions for terminally ill or LTCF patients, shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of the medication.
4.7.2 Partial Filling of Controlled Substance Prescriptions
4.7.2.1 Schedule II prescriptions may be dispensed up to 100 dosage units or a 31 day supply, whatever is the greater, and may be filled in partial quantities. 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 and must be filled not later than 30 days after the date on which the prescription is written. In accordance with 21 CFR Section 1306.13(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, and must be filled not later than 60 days after the date on which the prescription is written.
4.7.2.2 Schedules III, IV and V prescriptions may be filled in partial quantities provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed and must be filled not later than 6 months after the date on which the prescription is written.
4.8 Mail Order Prescription. Before dispensing prescriptions for Schedules II, III, IV and V controlled substances by mail, the registrant or the pharmacist-in-charge must assure that the prescription is valid and written by a prescriber properly registered with the Federal Government. Such verification may be made either in writing or orally.
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.
4.9.1 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.
4.9.2 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.
4.10 The pharmacist must establish that a practitioner is properly registered to prescribe controlled substances under Federal Law.
4.10.1 The pharmacist or an employee under the pharmacist's direct supervision must verify the identification of the receiver of the controlled substance prescription by reference to valid photographic identification. For the purposes of this section, a valid photographic identification is limited to the following:
4.10.1.1 A valid Delaware motor vehicle operator's license which contains a photograph of the person receiving the prescription - record the license number listed on the license as part of the patient record.
4.10.1.2 A valid Delaware 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.
4.10.1.3 A valid United States passport.
4.10.1.4 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:
4.10.1.4.1 Contains a photograph of the person receiving the prescription.
4.10.1.4.2 Is encased in tamper-resistant plastic or is otherwise tamper-resistant.
4.10.1.4.3 Identifies the date of birth of the person receiving the prescription and has an identification number assigned to the document which can be recorded as part of the patient record.
4.10.2 Identification for mail order dispensed controlled substances must comply with all federal standards.
4.10.3 No filled prescription for any Schedule II controlled substance may be received at any drive through window unless the pharmacy is authorized to do so by the Office of Controlled Substances. Written prescriptions for Schedule II controlled substances may be initially presented at a drive through if the pharmacy has not obtained authorization, but the filled prescription must be picked up inside the pharmacy. Authorization to permit the receipt of filled Scheduled II controlled substances prescriptions at a drive through window may be granted only if the pharmacy can demonstrate all of the following:
4.10.3.1 A security camera system that captures clear images of the driver's face and the license plate of the vehicle receiving any filled prescription; and
4.10.3.2 A written policy indicating that when picking up a Schedule II controlled substance at a drive through window, the driver must be recorded as the person picking up the prescription; and
4.10.3.3 A written policy requiring staff to review the identification of the driver, capture an image of the identification of the driver, and store that image in the pharmacy's records for at least three years for every filled Schedule II prescription picked up at the drive through window.
4.11 Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, no Schedule V cough preparation containing codeine, dilaudid or any other narcotic cough preparation may be dispensed without the written or oral prescription of a practitioner.
