For additional questions, see Pharmacy FAQ’s.
How do I register to prescribe controlled substances?
Answer: You must have all of the following to apply for a Delaware controlled substance registration (CSR):
If you meet the above requirements, refer to these pages for instructions on applying for Delaware CSR registration:
When you receive your Delaware CSR, you must apply for a federal DEA registration for Delaware (a DEA registration in another jurisdiction is not sufficient). For instructions on applying, see DEA New Registration Applications.
How long does it take to process my application?
Answer: The time period for the processing your controlled substance application is 4-6 weeks after your permanent professional license (e.g., as a physician, APRN, dentist, veterinarian, etc.) is issued.
Do I need two separate registrations for two different offices?
Answer: You need only one Delaware CSR to prescribe controlled substances in Delaware even if you prescribe controlled substances at more than one Delaware business/practice or more than one location of a business/practice. However, every Delaware location where controlled substances are dispensed/stored must be covered by a CSR. If no other practitioner (e.g., physician), physician assistant or APRN holds a Delaware CSR for a location where you will store/dispense, as well as prescribe, controlled substances, you must file for an additional CSR for the location.
What does the law say about verbally communicated prescriptions?
Answer: According to the Uniform Controlled Substances Act Regulations, only the prescriber may communicate a verbal prescription for a controlled substance to a pharmacist. Prescriptions for controlled substances communicated by the prescriber’s employee or agent are not valid. However, an employee or agent of the prescriber is allowed to verbally communicate prescriptions for non-controlled substances.
Does Delaware law allow electronically originated controlled substance prescriptions?
Answer: A prescriber or the prescriber’s authorized agent may send written prescriptions for controlled substances by fax to a pharmacy when the transmission complies with 21 CFR 1306.11, 1306.21 and 1306.31 and Delaware Controlled Substance and Pharmacy Rules and Regulations. The prescriber must hand-sign prescriptions for controlled substances transmitted by fax (Section 4.4 of the Controlled Substance Regulations). In addition, all other state and federal requirements must be followed when receiving and transmitting faxed prescriptions. See Section 5.0 of the Pharmacy Regulations.
For information about the implementation of electronically originated controlled substance prescriptions, see e-Prescriptions for Controlled Substances.
When am I allowed to issue a controlled substance prescription?
Answer: A practitioner acting in the usual course of his or her professional practice may issue a controlled substance prescription for a legitimate medical purpose (21 CFR 1306.04). Responsibility for properly prescribing and dispensing controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order that is 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 the law (21 U.S.C. 829). A person who knowingly fills such a purported prescription, as well as the person issuing it, will be subject to the penalties for violations of the provisions of controlled substances law.
A prescription may not be issued for:
What is the expiration for a controlled substance prescription?
Answer: Prescriptions for Schedule II and III controlled substances become void if not dispensed within seven days of the original date of the prescription unless the original prescriber authorizes the prescription past the seven-day period.
How much can I prescribe and dispense?
Answer: You cannot write prescriptions or dispense Schedule II and III controlled substances for more than 100 dosage units or a 31-day supply, whichever is greater, at a time.
Does Delaware law permit multiple Schedule II prescriptions with different dates?
Answer: Multiple Schedule II prescriptions for the same patient but different dates are permitted. Each prescription must:
What is the policy for prescription pad security and storage?
Answer: The availability of prescriptions has led to controlled substance diversion on a number of occasions. Under Section 4.0 of the Delaware Controlled Substance Regulations, only a practitioner who is authorized to prescribe controlled substances is allowed to issue a prescription for controlled substances. Practitioners and licensed healthcare facilities are held accountable for any loss or theft of controlled substances that results from the loss or theft of blank prescriptions that are then used to criminally obtain substances of abuse.
For the reasons listed above, the Office of Controlled Substances recommends that you, as a practitioner, keep your prescription pads only on your person. If it is absolutely necessary to store blank prescriptions in your office or facility, store them separately and securely under lock and key. Do not allow prescription pads to be accessible to the public or to facility staff (e.g., pharmacists, nurses, etc.). Develop a policy to address this issue at each facility, and include the policy in the facility’s policy/procedure manual. Make attending practitioners aware of the policy.
What are the standards for securely storing controlled substances in a practitioner’s office?
Answer: Schedule II controlled substances must be stored in a burglar-resistant safe or GSA Class 5 grade steel cabinet or equivalent. If the safe weighs less than 750 pounds, it must be bolted, cemented or secured to the wall or floor so that it cannot be readily removed. Other types of similarly constructed, securely locked cabinets or drawers are acceptable provided that the room or storage area has electronic intrusion detection equipment capable of detecting four-step movement in the area(s) where Schedule II controlled substances are stored. If excessive diversion of controlled substances occurs, additional security requirements may be deemed necessary. See Section 5.0 of the Delaware Controlled Substance Regulations for more information.
What are the standards for storing controlled substances in a Delaware-licensed Pharmacy?
Answer: Pharmacies must store Schedule II controlled substances in a burglar-resistant safe or GSA Class 5 grade steel cabinet or equivalent. If the safe weighs less than 750 pounds, it must be bolted, cemented or secured to the wall or floor so that it cannot be readily removed. If excessive diversion of controlled substances occurs, additional security requirements may be deemed necessary.
What can a Pharmacist change on a controlled substance prescription?
Answer: A Pharmacist can change a controlled substance prescription but only after contacting the prescriber. After consulting with the prescriber, the pharmacist is permitted to change:
The pharmacist is also allowed to add the following but only after verifying it:
The pharmacist is never permitted to change:
What are the partial filling requirements for a Schedule II controlled substance?
Answer: Federal regulations allow for the partial filling of a Schedule II controlled substance when the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription (21 CFR 1306.13). The pharmacist must note the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling. However, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist must notify the prescriber. No further quantity may be supplied beyond the 72 hours without a new prescription.
How do we transfer controlled substances between Pharmacies?
Answer: Pharmacies are permitted to transfer original prescription information for a controlled substance listed in Schedules III, IV, or V to another pharmacy on a one time basis only (21 CFR 1306.25 (a)). Pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. Transfers are subject to the following requirements: