24 Del. Admin. Code § 8.0
Current through Register Vol. 28, No. 5, November 1, 2024
Section 8.0 - Practitioner Dispensing of Controlled Substances8.1 No prescriber who is not the owner of a pharmacy or who is not in the employ of such owner, may dispense more than a 72-hour supply of schedule II through V controlled substances except for the following, who still must comply with other sections of this Regulation including but not limited to subsection 4.7 of this regulation: 8.1.1 A practitioner who confines their activities to dispensing complimentary packages of controlled substances to the practitioner's own patients in the regular course of their practice without payment of a fee or remuneration of any kind, whether direct or indirect.8.2 Any registered practitioner who dispenses controlled substances for sale must adhere to all State and federal laws including but not limited to the following:8.2.1 Must notify the Office of Controlled Substances prior to dispensing any controlled substance that they will be dispensing controlled substances for sale. 8.2.1.1 A practitioner who confines their activities to dispensing complimentary packages of controlled substances to the practitioner's own patients in the regular course of their practice without payment of a fee or remuneration of any kind, whether direct or indirect, and who dispenses the drug themselves is not required to notify the Office of Controlled Substances.8.2.2 Before dispensing any controlled substance the patient must be advised that the prescription may be filled in the practitioner's office or any pharmacy.8.2.3 Prior to dispensing the practitioner must conduct a medication reconciliation review and offer to counsel the patient.8.2.4 Prior to dispensing the practitioner must inspect the prescription product to verify its accuracy in all respects and personally place his initials on the record of sale as certification of the accuracy of, and the responsibility for, the entire transaction.8.2.5 If the patient chooses to purchase the controlled substance from the practitioner, the practitioner shall have the patient sign the prescription and return it to the practitioner as a hard copy record of the sale. If the practitioner chooses to record the sale in book form or maintain it in an automated data system, he shall mark the prescription void, file chronologically and maintain a record for at least two years.8.2.6 Inventories and records of all controlled substances listed in schedule II shall be maintained separately from all other records of the registrant.8.2.7 Inventories and records of controlled substances listed in schedules III through V may be maintained separately from schedule II controlled substances records but shall not be maintained with non-controlled substances records of the registrant.8.2.8 All records of schedule II through V controlled substances shall be maintained at the office site or an off-site retrievable within 72 hours of a request of the Office of Controlled Substances.8.2.9 Practitioners shall perform an inventory of controlled substances at least every two years.8.2.10 Compounding of a controlled substance by a practitioner is permitted as long as the United States Pharmacopoeia (USP) 795 and 797 standards and guidelines are followed.8.2.11 Technicians may assist practitioners in the filling processes but only under direct supervision of the practitioner.8.2.12 Practitioners must comply with all previous sections of this Regulation.8.3 Administrative inspections of controlled premises may be conducted in accordance with the provisions under 16 Del.C. § 4782.24 Del. Admin. Code § 8.0
25 DE Reg. 873 (3/1/2022) (Final)