1. What do I need to do for continuing education?
2. What are the building requirements for a new pharmacy located in Delaware?
3. Do I need to reapply for a new license if there is a controlling interest change in ownership of a pharmacy?
4. What do I need to do to close a pharmacy?
5. What are the procedures for drug substitution in Delaware?
6. What are my responsibilities as a Pharmacist-In-Charge? What if the Pharmacist-in-Charge changes?
7. Is a Pharmacy or Pharmacist allowed to accept returned medications for re-dispensing?
8. What are a consultant pharmacist’s responsibilities?

For more questions, see Controlled Substances FAQ’s.

Answers

What do I need to do for continuing education?

Answer: Section 1.4  and Section 14.1.3.1 of the Board of Pharmacy Rules and Regulations explains the continuing education (CE) requirements for pharmacists. You may also visit the Continuing Education and Audit Information webpage. Section 1.5 explains CE programs. Individual programs must meet the criteria for CE provider approval. If the CE provider is neither an approved American Council on Pharmaceutical Education (ACPE) provider nor Board-approved provider, you may submit a Service Request for CE Provider Approval in DELPROS online portal for CE approval.

What are the building requirements for a new pharmacy located in Delaware?

Answer: Pharmacy applications (whether new, relocated or remodeled) must be accompanied by three copies of floor plans, drawn to scale, of the proposed prescription department. The pharmacist-in-charge or applicant must submit the floor plans before any construction and shall notify the Board within fifteen days after the completion of the remodel for inspection to take place.  You must submit a Service Request  for In-State Pharmacy Remodeling in DELPROS before any construction.  A temporary permit is required when the pharmacy relocates to a temporary facility.

The plans must show that the pharmacy will meet the requirements in the Pharmacy law at 24 Del C. §2533:

• 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.

In addition to the requirements in the law listed above, the plans must show:

• area to facilitate counseling that affords patient privacy. 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
• 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 pharmacy department is closed and the remainder of the store is open
• type of alarm system and name, address and phone number of alarm provider

Note: The Office of Controlled Substances must review and approve the alarm system.

Do I need to reapply for a new license if there is a controlling interest change in ownership of a pharmacy?

Answer: Yes. New ownership requires a new license.

What do I need to do to close a pharmacy?

Answer: The Delaware-licensed pharmacist-in-charge (PIC) (or, if the PIC is deceased, another designated Delaware-licensed pharmacist) is responsible for carrying out the closing procedure. Submit the following information to the Pharmacy Board office at least 14 days before the planned closing.  This information can be reviewed in Section 4.0 of the Board’s Rules and Regulations:

• certified letter
• name, address and phone number of the closing pharmacy
• Pharmacy license number, Controlled Substance registration number and Drug Enforcement Administration registration number
• name of the PIC responsible for the closing
• date of closing
• name, address and phone number of the licensed pharmacy to which prescription drugs, prescription files and patient profiles will be transferred
• name and phone number of the person to contact in an emergency after the closing of the pharmacy

The PIC (or designated pharmacist) is also responsible for arranging the following:

• publication in a local newspaper for one week informing the public that the pharmacy will be closing on a specific date and the name of the pharmacy where the prescriptions will be transferred
• posting of sign in the window of the pharmacy at least 14 days before closing and at least 14 days after closing informing the public where prescriptions are being transferred
• removal of all signs that refer to “pharmacy”, “apothecary”, “drugs”, or “medicine” within 30 days of closing

The PIC must also submit the following to the Board of Pharmacy/Office of Controlled Substances:

• closing inventory of all controlled substances signed and dated by the PIC
• name, address, and phone number of the custodian of controlled substance records for the two-year period after closing
• Delaware Pharmacy license and Controlled Substance registration

Upon closing, these permits and registrations must be surrendered to the DEA:

• Federal Controlled Substance Certificate
• all unused 222 Schedule order forms

What are the procedures for drug substitution in Delaware?

Answer: FDA approval for any drug product addresses quality concerns for the manufacturing process of that particular medication. Whether a product can be used as a generic equivalent of a brand name product depends on the rating of the branded product. Delaware law recognizes the FDA rating of medication via the Orange Book. When the FDA has rated a branded drug with an AB rating, you may substitute the generic for the branded drug. If the branded product is not AB-rated, interchanging generic products is not permitted. Delaware law at 24 Del. C. §2549 currently allows a pharmacist to dispense a therapeutically equivalent drug for a practitioner’s prescription of a brand or trade name drug when all the following are met:

• The prescribing practitioner authorizes the substitution as follows:
  • If the prescription is written, the practitioner placed his/her signature on the line next to or above the words “substitution permitted”.
  • If the prescription was verbal or verbal prescription reduced to writing, the practitioner states that the substitution may be made.
  • If the order was written in an institution licensed by the Division of Professional Regulation, the practitioner gave written authorization to fill all prescription drug orders with therapeutically equivalent drugs unless otherwise indicated.
• The pharmacist:
  • informs the patient or the patient’s adult representative that a therapeutically equivalent drug has been dispensed
  • indicates on the prescription and on the label the name of the manufacturer or distributor of the therapeutically equivalent drug substituted

In addition, pharmacists must follow all other requirements in state and federal law. This includes, but is not limited to, labeling requirements in 24 Del. C. §2522 on labeling and 24 Del. C. § 2549 (c) on prescription forms.

What are my responsibilities as a Pharmacist-In-Charge? What if the Pharmacist-in-Charge changes?

Answer: Section 3.1 of the Board’s Rules and Regulations explains the requirements and responsibilities of the Pharmacist-in-Charge (PIC). One of these requirements is that a new PIC who has never been a PIC in Delaware must appear before the Board for an interview within 90 days of assuming the position. In addition, the PIC of a Delaware-licensed community pharmacy must complete a Community Pharmacy Pharmacist-in-Charge Self-Inspection Report:

• within 30 days of first being designated as PIC, and
• by February 1 of each year while you continue as the PIC

When the PIC of a Delaware pharmacy leaves his/her position, notify the Board office using the Report of Pharmacist-in-Charge Change and Acknowledgement form within 10 days (Section 3.1.2.6). The incoming PIC must sign the form to acknowledge his/her new responsibilities.  These forms can be submitted via:

• upload in the DELPROS Portal as a service request for Manage Affiliations, if you have access to the facility’s license
• upload in the DELPROS Portal as “Submit Additional Documentation” under your license OPTIONS, if you have access to your individual license
• email to DPR customer service: customerservice.dpr@delaware.gov

In addition, the present (outgoing) and prospective (incoming) PICs must complete an audit of all controlled substances, under 16 Del. C., Chapter 47, within 24 hours of a PIC change.  The Office of Controlled Substance (OCS) recommends that the incoming and outgoing PICs take the inventory at the same time, either at the start or the close of the business day. Forward a copy of this inventory to the attention of OCS in the Division of Professional Regulation. Retain another copy on the premises for a period of at least two years. The inventory must include:

• name and address of the registrant
• registrant’s DEA number
• date and time that the inventory was completed
• names of the pharmacists performing the inventory

Is a Pharmacy or Pharmacist allowed to accept returned medications for re-dispensing?

Answer: You are not allowed to accept medications for return or exchange after they are removed from the pharmacy (Section 5.1.14 of the Board’s Rules and Regulations). The reasoning behind this rule is that a medication that has left the control of the pharmacy is susceptible to any range of issues that could affect its safety and effectiveness in treatment.

Exception: You may accept and redispense unused, unexpired products under certain conditions. See Section 5.1.14.2 of the Rules and Regulations.

What are a consultant pharmacist’s responsibilities?

Answer: Section 11.6 of the Board’s Rules and Regulations delineates the duties and responsibilities of a consultant pharmacist and provider pharmacy. The consultant pharmacist must notify the Board in writing within ten days of starting as a consultant in Delaware. If the consultant pharmacist has not previously served in that position in Delaware, he/she must appear before the Board for an interview within ninety days of assuming the position.