When to File Application
A pharmacy located outside Delaware must hold a Delaware Non-Resident Pharmacy permit in order to ship, mail, or deliver, in any manner, any controlled substance or prescription drug to a patient in Delaware (24 Del. C. §2535). Non-Resident Pharmacies must comply with Title 24, Chapter 25 of the Delaware Code when dispensing for Delaware clients.
File the application form for Non-Resident Pharmacy licensure when:
- Applying for an initial Delaware Non-Resident Pharmacy permit, or
- Re-applying after a previous Delaware Non-Resident Pharmacy permit has lapsed and is no longer renewable, or
- Applying for a new Non-Resident Pharmacy permit due to a change of ownership or controlling interest. (Permits are not transferable.) The application must be filed within 30 days of the ownership change.
This application form is not required when either of the following events occurs. In these situations, see Reporting Non-Resident Pharmacy Change of Address or Name below.
- Relocation of pharmacy or other address change where no change in controlling interest has occurred
- Name change where no change in controlling interest has occurred.
Important Information about Delaware Controlled Substances Registration
If the non-resident pharmacy dispenses controlled substances to patients in Delaware, a separate Application for Facility Controlled Substances Regisration is required. If the non-resident pharmacy must file a new application or re-application for a Non-Resident Pharmacy permit (e.g., due to ownership change), a new application or re-application for controlled substance registration application is also required.
A pharmacy must have a Delaware Pharmacy permit, Delaware controlled substance registration and federal DEA permit before storing and/or dispensing controlled substances in Delaware.
Requirements for All Applications
These requirements apply to all applications, whether initial filing or re-application. Read and follow instructions carefully. Failing to follow instructions will delay processing of your application.
- Arrange for the pharmacist-in-charge (PIC) to sign the PHARMACIST-IN-CHARGE ACKNOWLEDGMENT section.
- PIC changes must be reported to the Board of Pharmacy within 10 days of the change. Use the Report of Pharmacist-in-Charge Change form.
- The PIC of a Nuclear Pharmacy must be a Qualified Nuclear Pharmacist. He or she is responsible for all Pharmacy operations and must be personally on the premises at all times that the Pharmacy is open for business.
- To receive news and alerts from the Delaware Board, a current email address is essential. If the PIC is a Delaware-licensed Pharmacist, the PIC can keep all of his or her contact information up-to-date online at Change Contact Information. If the PIC is not Delaware-licensed, he or she can report contact information changes to the Board office by mail or email.
- Enclose the non-refundable processing fee by check or money order made payable to the “State of Delaware.”
- Enclose a copy of each permit, registration or license held by this pharmacy in the jurisdiction (state, U.S. territory or District of Columbia) where it is located and dispenses medications.
- Enclose a separate sheet showing the following information for each owner, corporate officer, pharmacist and non-registered pharmacy employee listed on the application:
- Date of Birth
- Mailing Address
- Enclose a sample label showing the pharmacy’s toll-free number 24 Del. C. §2537(a)(4) and the following requirements from 24 Del. C. §2522(b):
- Prescription number
- The date the prescription is dispensed
- Patient’s full name
- Brand or established name and strength of the drug to the extent that it can be measured
- Practitioner’s directions as found on the prescription
- Practitioner’s name
- Name and address of the dispensing pharmacy or practitioner
- Enclose a copy of the most recent inspection report from the licensing agency of the jurisdiction where the pharmacy is located.
- Enclose a sample patient profile that meets the requirements of Section 5.0 of the Board’s Rules and Regulations. Label each of the following required items on the sample profile:
- Patient’s family name and first name
- Patient’s address and phone number (or location in institution)
- Patient’s gender and age or date of birth
- Original date the medication is dispensed after receiving the prescription
- Number or designation for prescription
- Prescriber’s name
- Name, strength, quantity, directions and refill information of drug dispensed
- Appropriate directions must also be present if medication is for patients in institutions
- Initials of dispensing pharmacist and date of dispensing medication as a refill if those initials and date are not recorded on original prescription
- If patient refuses to give all or part of the required information, indicate and initial in the appropriate area
- Pharmacist comments relevant to the patient’s drug therapy, including any other information peculiar to the specific patient or drug
- Notes on the patient’s allergies, idiosyncrasies, chronic diseases, frequently used over-the-counter medications. If none, this must also be shown on the profile.
Reporting Non-Resident Pharmacy Change of Address or Name
You may report an address change or name change by letter provided no change of ownership or controlling interest has occurred. You must report the change within 10 days of its occurrence. When reporting, note the following:
- The letter should include:
- pharmacy name as it appears on current permit
- license number
- old information
- new information
- effective date of the change.
- Enclose duplicate license fee by check or money order made payable to the “State of Delaware.” The duplicate license will reflect the new name and address.
If the pharmacy opens additional sites where medications will be dispensed, you must file an application for a permit for each additional business site.