For more questions, see Controlled Substances FAQ’s.
What do I need to do for continuing education?
Answer: Section 1.4 of the Board of Pharmacy Rules and Regulations explains the continuing education (CE) requirements for pharmacists. 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 complete Request for Individual Program 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 at least 15 days before the next scheduled Board of Pharmacy meeting.
The plans must show that the pharmacy will meet the requirements in the Pharmacy law at 24 Del C. §2533:
In addition to the requirements in the law listed above, the plans must show:
Do I need to reapply for a new license if there is a controlling interest change in ownership of a pharmacy?
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:
The PIC (or designated pharmacist) is also responsible for arranging the following:
The PIC must also submit the following to the Board of Pharmacy/Office of Controlled Substances:
Upon closing, these permits and registrations must be surrendered to the DEA:
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:
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. In addition, the PIC of a Delaware-licensed community pharmacy must complete a Pharmacist-in-Charge Self-Inspection Report:
When the PIC of a Delaware pharmacy leaves his/her position, notify the Board office using the Report of Pharmacist-in-Charge Change form within 10 days (Section 188.8.131.52). The incoming PIC must sign the form to acknowledge his/her new responsibilities. In addition, the present (outgoing) and prospective (incoming) PICs must inventory all medications covered under 16 Del. C., Chapter 47. 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:
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.
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.