Delaware Administrative Code
Title 24 - Regulated Professions and Occupations
Department of State
Division of Professional Regulation
Uniform Controlled Substances Act Regulations
Section 6.0 - Records and Inventory

Universal Citation: 24 DE Admin Code 6.0

Current through Register Vol. 28, No. 3, September 1, 2024

6.1 Requirements

6.1.1 All practitioners and pharmacies registered and authorized to prescribe or dispense controlled substances shall maintain records that adhere to all State and federal laws.

6.1.2 Practitioners authorized to prescribe or dispense controlled substances shall maintain a record with the following information:
6.1.2.1 Name and address of patient;

6.1.2.2 Date prescribed;

6.1.2.3 Name, strength, refills authorized and amount of medication.

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.

6.1.4 Other persons registered to manufacture, distribute, or dispense controlled substances shall maintain a record with the following information:
6.1.4.1 Amount received or distributed;

6.1.4.2 Names, addresses and dates regarding these transactions;

6.1.4.3 Other records required by 21 CFR 1300 to the end of 1316.

6.1.5 When a pharmacy relocates to a new building, or there is a change in Pharmacist-in-Charge, a complete audit of all controlled substances must be conducted before the move and within twenty-four hours after the move is complete or the PIC change occurs. If the relocation occurs in the same building, no inventory count shall be required, so long as a pharmacist physically moves the controlled substance inventory.

6.1.6 Transfers of controlled substances are only permitted if both parties are registered. Transfers of schedule II controlled substances must be transferred via DEA 222 forms. Schedule III through V transfers may be done so via invoice. Controlled substances obtained under one registration must be transferred according to this procedure when this registrant wants to transfer possession of said controlled substances to another registrant.

6.2 Accountability Audits

6.2.1 Accountability audits in pharmacies will be accomplished through a review of invoices, prescription files, other records required by 21 CFR 1300 to the end of 1316.

6.2.2 Accountability audits of registered practitioners will be accomplished through a review of records to be kept by paragraph 6.1 of this section.

6.2.3 Accountability audits of registered manufacturers and distributors (including wholesalers) will be accomplished through a review of invoices received and distributed and other records required by 21 CFR 1300 to the end of 1316.

6.3 Final Inventory

6.3.1 Pharmacies. Whenever the pharmacist in charge of a pharmacy in the State of Delaware leaves that pharmacist's 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.

6.3.2 Registered practitioners who cease legal existence or discontinue business or professional practice shall notify the Office of Controlled Substances within 30 days of such fact, and shall provide the Office with an inventory of controlled substances on hand.

6.4 Retention of Records

6.4.1 All records required by this Regulation must be retained for a period of at least two (2) years.

Disclaimer: These regulations may not be the most recent version. Delaware may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.