- What are the criteria for Board membership?
- What do I need to do for continuing education?
- What are the building requirements for a new in-state pharmacy?
- Do I need to reapply for a new licensure if there is a controlling interest change in ownership?
- What do I need to do to close a pharmacy?
Question:
What are the criteria for Board membership?
Answer: The State Board of Pharmacy consists of nine persons appointed by the Governor for three-year terms from the first day of July in the year of appointment.
Five members must:
- Be graduates of a school or college of pharmacy accredited by the American Council on Pharmaceutical Education at the time of graduation.
- Be licensed as pharmacists in Delaware.
- Be residents of Delaware and actively engaged in the practice of pharmacy.
- Possess five years of experience in the practice of pharmacy in Delaware after licensure.
Three of the five professional members must reside in New Castle County, one in Kent County and one in Sussex County.
The other four members are designated as the "public members." They must:
- Be residents of Delaware.
- Be at least 18 years of age.
- Not have been a pharmacist at any time.
- Have no financial interest in a pharmacy.
- Have no pharmacist relations.
- Not have been included in the practice of activities directly related to the practice of pharmacy.
Question: What do I
need to do for continuing education?
Answer:
- A pharmacist must acquire 3.0 CEU's (30 hours) per two-year licensure period. No carryover credit from one license period to another period is permitted.
- The Board of Pharmacy may grant hardship exemptions upon receipt of evidence that the licensee was unable to complete the requirements due to circumstances beyond his/her control.
- Persons who are newly licensed after the license period begins must complete CEU’s proportional to the total number of CEU’s required for the full two-year license period. (1.25 hours/per month)
- Individual programs must meet the criteria for provider approval in order to be considered. Where the provider is not an American Council on Pharmaceutical Education (ACPE) provider, nor a Board of Pharmacy approved provider, a licensee may complete Request for Individual Program Approval.
- To receive full credit for non-ACPE approved programs of one-to-two hour lengths, evidence of a post-test must be presented. If no post-test is presented, there will be a 25% deduction.
- To receive full credit for non-ACPE approved programs of three or more hours in length, evidence of a pre and post test must be presented. There will be a 25% deduction if no pre or post test is presented.
- The Board will assign credit only for the core content of the program which explicitly relates to the contemporary practice of pharmacy.
- A maximum of two credit hours will be awarded for First Aid and CPR/BCLS courses one time only per license period.
- The pharmacist will be responsible for providing the Board with verification of completion of the required CEU by such means as designated by the Board.
Question: What are the
building requirements for a new in-state pharmacy?
Answer:
The requirements, listed in 24 Del C. §2534 (f)(1) through (4), are:
- The pharmacy department must occupy at least 250 square feet of floor space excluding storage room.
- The prescription counter must be at least 18 inches wide.
- The counter must contain an additional space for computers if applicable.
- The aisle behind the counter must be at least 30 inches wide and kept clear of obstruction.
An application to operate a new pharmacy must include (3) copies of floor plans drawn to scale of the proposed prescription department. The floor plans must include the following:
- The requirements listed in §2534(f)(1) through (4).
- An area to facilitate counseling must be provided. This area must afford the patient privacy from auditory detection by an unauthorized person or persons. An area partitioned by a five-foot divider on two sides with a minimum of nine square feet would satisfy this requirement in most settings.
- The floor plans must show the location of the sink, all doors, storage room, approved Schedule II controlled substance safe or cabinet, and the method of securing the prescription department from floor to ceiling when the prescription department is closed and the remainder of the store is open,
- The floor plans must include the type of alarm system to be installed as well as the name, address and phone number of alarm provider. The Office of Narcotics and Dangerous Drugs must review and approve the alarm system, as required by Regulation 5 of the Delaware Controlled Substance Act.
The above requirements also apply to any remodeling or change of location of the prescription department. The pharmacist-in-charge or applicant for permit must submit the floor plans requirements to the Delaware Board of Pharmacy and the Office of Narcotics and Dangerous Drugs prior to any construction and at least 15 days prior to the next scheduled Board of Pharmacy meeting for its review.
Question: Do I need
to reapply for a new licensure if there is a controlling
interest change in ownership?
Answer: Yes. New ownership would require a new
license.
Qestion: What do I need
to do to close a pharmacy?
Answer: These closing procedures will be completed by a Delaware-licensed pharmacist-in-charge, or in the event of death, a Delaware-licensed pharmacist designated to perform the closing procedure.
The following information must be submitted to the Board office:
- Certified letter at least fourteen (14) days prior to the planned closing.
- Name, address and phone number of the closing pharmacy.
- Pharmacy permit and Delaware Controlled Substance registration number and Drug Enforcement Administration registration numbers.
- Name of the pharmacist-in-charge who is responsible for the closing.
- Date of the closing.
- Name, address and phone number of the licensed pharmacy to which prescription drugs, prescription files and patient profiles will be transferred.
- Publication in a local newspaper for one week informing the public that the pharmacy is closing on a specific date and the name of the pharmacy to which the prescriptions will be transferred.
- Name and phone number of the person to contact in an emergency after the closing of the pharmacy.
- Sign posted in the window of the pharmacy at least fourteen (14) days prior to closing and to remain fourteen (14) days after closing informing the public where prescriptions are being transferred.
- Removal of all signs within thirty (30) days of closing that refer to "pharmacy", "apothecary", "drugs", or "medicine".
The permits and registrations to be surrendered upon closing are:
- Pharmacy Permit (Executive Secretary, Board of Pharmacy)
- Delaware Controlled Substance Registration (Director, ONDD)
- Federal Controlled Substance Certificate (DEA)
- All unused 222 Schedule order forms (DEA)
Information that must be submitted to the Office of Narcotics and Dangerous Drugs (ONDD) includes:
- Closing inventory of all controlled substances signed and dated by both the new and past pharmacists-in-charge. (ONDD recommends that both pharmacists-in-charge complete this inventory at the same time.)
- Name, address, and phone number of the custodian of controlled substance records for the two year period after closing, as required by 21 Code of Federal Regulations.
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