Objective and Function
The primary objective of the Controlled Substance Advisory Committee is to promote, preserve and protect the public health, safety and welfare by regulating and monitoring use and abuse of controlled substances. To meet this objective, the Committee
- carries out a program of registration, inspection, investigation and education
- recommends new/revised rules and regulations and disciplinary sanctions against registrants to the Secretary of State
The Committee issues registrations to practitioners and facilities that prescribe, dispense, manufacture and distribute controlled substances. Practitioners include physicians, physician assistants, advanced practice nurses, podiatrists, dentists and veterinarians. Facilities include pharmacies, distributors, manufacturers, hospitals, clinics, researchers, laboratories and provider pharmacies.
To assist the Committee, the Drug Control Administrator for the Division of Professional Regulation is responsible for the Committee's regular administrative functions.
The Committee meets every other month. All meetings are open to the general public. They are usually held in the Buena Vista Conference Center, 661 S. Dupont Hwy., Buck Library, 1st Floor, New Castle, DE 19720, but the location is subject to change. Check the meeting calendar to confirm dates and location.
To ensure that business (such as a license application) is on the agenda for the Committee's consideration at its next meeting, submit all documentation to the Committee office no later than 4:30 PM ten full working days before the meeting date.
NEW FEDERAL REGULATION CHANGES SCHEDULE OF HYDROCODONE COMBINATION PRODUCTS: Effective on October 6, 2014, a final Drug Enforcement Administration (DEA) rule changes hydrocodone combination products (HCPs) from schedule III to schedule II of the Controlled Substances Act. For full information on the final rule, see the Federal Register. The new requirements are summarized below:
Anyone who registers with the Drug Enforcement Administration (DEA) on or after October 6, 2014 must take an initial inventory of all stocks of controlled substances (including HCPs) on hand on the date that he or she first engages in handling controlled substances. After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including HCPs) on hand every two years (21 U.S.C. 827 and 958, 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b)).
- Prescriptions for HCPs issued on or after October 6, 2014 may not authorize any refills (21 U.S.C. 829(a)) and must be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311.
- If a prescription that authorized refills was issued before October 6, 2014, the refills may be dispensed but only if the dispensing occurs before April 8, 2015 (21 CFR 1306.22-1306.23, 1306.25, and 1306.27). Although past prescriptions that still have refills remaining may be honored if dispensed before April 8, 2015, pharmacy computer systems that change HCPs to schedule II as of October 6, 2014 will be unable to dispense the remaining refills.
- Keep in mind that verbal and faxed schedule II prescriptions are not valid unless a federally-accepted allowance applies. In most circumstances, schedule II written or e-prescribed controlled substance prescriptions may be honored and dispensed.
EMERGENCY REGULATION: An emergency regulation effective on June 18, 2014 places limitations and requirements on prescribing extended-release hydrocodone that lacks abuse-deterrent formulation. The purpose of the rule is to protect the public by addressing the potential for prescription drug overdose, abuse and diversion. For complete information, see Section 11.0 of the Controlled Substance Regulations.
Phone - Fax - Email
861 Silver Lake Blvd.
Dover, DE 19904