Current through Register Vol. 28, No. 3, September 1, 2024
1.1 Definitions
Words and terms defined in Delaware Code Title 1, Section 302 and Title 24, Section 2502 of the Delaware Code are applicable to these regulations. The following additional words and terms, when used within these regulations, shall have the following meaning unless the context clearly indicates otherwise or an alternate definition has been given:
"Automated Data Processing System (ADPS)" means a system utilizing computer software and hardware for the purposes of recordkeeping.
"Cell" means any container that holds the medication for automatic dispensing.
"Central Prescription Processing" means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, DUR, claims adjudication, refill authorizations, and therapeutic interventions.
"Common Database" means a file or database created by an ADPS that enables authorized users to have common access to this file regardless of physical location.
"Compounding" means the art of the extemporaneous preparation and manipulation of drugs as a result of a practitioner's prescription order or initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice, including the preparation of drugs in anticipation of drug orders based on routine, regularly observed prescribing patterns.
"Computer" means a programmable electronic device, capable of multifunctions including but not limited to storage, retrieval and processing of information.
"Controlled Substance" means those drug items regulated by Federal (CSA of 1970) and/or State Controlled (dangerous) Substances Act.
"CRT" means a Cathode Ray Tube used to impose visual information on a screen.
"Delivery" means the transfer of a dispensed prescription to the ultimate user (patient) or his/her agent.
"Dispensing" means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner; including the preparation, packaging, labeling or compounding necessary to prepare the drug for that delivery.
"Downtime" means that period of time when a computer is not operable.
"Facsimile (FAX) Prescription" means a facsimile prescription is an order which is transmitted by an electronic device over telephone lines which sends an exact copy image to the receiver (pharmacy).
"New Medication" means a medication not previously dispensed by the pharmacy for the ultimate user.
"Patient Counseling" means an oral communication process between a pharmacist, or a registered intern or a pharmacy student working under the direct supervision of a pharmacist, and a patient, in which the pharmacist obtains information from the patient and the patient's pharmacy records, assesses that information and provides the patient with professional advice regarding the safe and effective use of the prescription drug for the purpose of assuring therapeutic appropriateness. Patient counseling may be provided through telehealth.
"Pertinent Patient Medication Information" means information which increases the patient's ability to minimize the risks and enhance the benefits of drug use. The type of information the pharmacist should consider is contained in the latest edition of USP DI "Advice for the Patient."
"Prescriber" means a practitioner authorized to prescribe and acting within the scope of this authorization.
"Prescription" or "Prescription drug order" means the lawful written or verbal order of a practitioner for a drug, but does not include an order for medication which is dispensed for immediate administration to the ultimate user, (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)
"Printout" means a hard copy produced by computer that is readable without the aid of any special device.
"Reduced to Writing" means the preparation of a paper document containing all the information required for a written prescription including the State requirement for drug product selection;
For a refill authorization, it may be handled as a new prescription as in above, or by placing on the original prescription or the patient profile (whichever document is consistently used to document refills) the date, a statement "O.K. for 'x' number of additional refills", or words of similar import, and the pharmacist's initials. In no instance, shall the refill authorizations exceed the legal limits established by State and Federal laws.
If the prescriber authorizing additional refills differs from the prescriber whose name appears on the signature line of the original prescription, then that authorization is considered a new prescription and must be handled as described above.
"Regulatory Agency" means any Federal or State agency charged with enforcement of pharmacy or drug laws and regulations.
"Stop Date" means a date established by an appropriate authority which indicates when medication will no longer be administered or dispensed in the absence of a specific time period directed by the prescriber.
"Telehealth" means the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services as described in regulation. Telehealth may be used for patient counseling only.
1.2 Examination Requirements
1.2.1 All applicants must obtain a passing grade as determined by the National Association of Boards of Pharmacy (NABP) on the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination for Delaware (MPJE) to be eligible for a license to practice in Delaware.
1.2.2 In order for Delaware to be able to make a candidate eligible to take the NAPLEX or MPJE exam(s), the candidate must first register with and pay the exam fee to the National Association of Boards of Pharmacy (NAPB). For more information on this process, please refer to the Registration Bulletin at: http://www.napb.net.ftpfiles/bulletins/NAPLEXMPJE.pdf on the NAPB website and http://www.dpr.delaware.gov/boards/pharmacy/newpharmacist.shtml on the Division of Professional Regulation website.
1.2.3 In order to be made eligible to take either exam, an applicant must submit the appropriate processing fee along with a completed Pharmacist application, which will contain the following information:
1.2.3.1 Proof of completion of all of the requirements for graduation from an approved school or college. Proof of completion should either be a "Certificate of Graduation in Pharmacy" form, a "Foreign pharmacy graduate Committee (FPGEC) Certification or a letter from the pharmacy school or college that the graduate has met all of the requirements for graduation."
1.2.3.1.1 An approved school or college of pharmacy is an institution which has established standards in its undergraduate degree program which are at least equivalent to the minimum standards for accreditation established by the American Council on Pharmaceutical Education.
1.2.3.1.2 Graduates of schools or colleges of pharmacy located outside of the United States, which have not established standards in their respective undergraduate degree programs but are equivalent to the minimum standards for accreditation established by the American Council on Pharmaceutical Education, shall be deemed eligible to take the NAPLEX and MPJE examinations. Applicants must provide evidence of successfully passing an equivalency examination recognized by the Board of Pharmacy. Certification by the National Association of Boards of Pharmacy (NABP) Foreign Pharmacy Graduate Examination Committee (FPGEC) meets the equivalency examination requirement.
1.2.3.1.3 Applicants who have not completed all the practical experience requirements, but who have graduated from an accredited college or have been certified by the NABP Foreign Pharmacy Graduate Examination Committee are eligible to take the examination. However, applicants will not be fully licensed until all the requirements of the Statute and Regulations are completed.
1.2.4 The Board will re-confirm the eligibility of an applicant who fails the NAPLEX. The applicant shall be entitled to take a re-examination at least forty-five (45) days following the date of the failure with a limit of three attempts in a 12-month period. If an applicant has failed the examination three times, and 12 months have passed since the failure of the last examination, he/she shall be eligible to re-take the NAPLEX, provided that he/she produces evidence of working full-time as an intern for a period of six months or has attended an accredited college of pharmacy as a registered student for a minimum of one semester consisting of 12 credits during the interim. "College Practical Experience" form or an "affidavit of Intern Experience" must be furnished by the Dean of the College or the preceptor whichever the case may be.
1.2.5 The Board will re-confirm the eligibility of an applicant who fails the MPJE. The applicant shall be entitled to re-take the MJPE at least thirty-one (31) days following the date of the failure. If an applicant has failed the examination three times, he or she shall be eligible to re-take the examination, provided that he or she produces evidence of working full-time as an intern for a period of three months or has completed a one semester college course on jurisprudence.
1.2.6 A candidate must take an examination within 365 Days of the determination of eligibility by the Board or they will have to re-register with NABP to be made re-eligible.
1.3 Practical Experience Requirements
1.3.1 In accordance with the requirements of 24 Del.C. §
2515, all Pharmacist applicants, with the exception of reciprocity (licensure transfer) applicants, are required to complete a minimum of 1500 hours of Board approved practical experience under the supervision of a licensed pharmacist before being licensed. A minimum of 1000 hours shall be obtained in the community or hospital settings. The remaining 500 hours may be obtained in other recognized fields of practice, e.g.: Industrial Pharmacist, Drug Information Pharmacist, Military Pharmacist, Mail Order Pharmacist, HMO Pharmacist, Consultant Pharmacist (Nursing Home, Infusion, Medicaid DUR, Etc.), Home Health Care Pharmacist (may include Durable Medical Equipment, etc.), Nuclear Pharmacist, Compliance Pharmacist, Government Pharmacist, Clinical Pharmacist, Contracted Pharmacy Services. If the applicant has not completed the required 1500 hours in another state, he or she will be required to register as an intern in Delaware to complete the required hours.
1.3.2 An applicant for registration as an intern must submit an "Application for Registration of Internship" after entering the first professional year of college of pharmacy. This application must include an "Affidavit of Class Standing" form and an "Affidavit of Preceptor" form. If the applicant is a graduate of a foreign pharmacy school, he/she must produce evidence that he/she has passed an equivalency examination by the Board.
1.3.3 Practical experience must be acquired under the supervision of a licensed pharmacist known as a Preceptor. The Preceptor must be a pharmacist licensed in this State or any other State and must have a minimum of two years of pharmacy practice. A pharmacist affiliated with a College of Pharmacy shall serve as the preceptor for a student participating in the coordinated practical experience program. The Preceptor must certify that the intern has successfully completed all the requirements outlined in the Responsibilities of the Intern professional assessment form.
1.3.4 Practical experience acquired in another State is acceptable if the State Board in which the applicant acquired the hours submits a letter of certification, or if the applicant's preceptor completes the Delaware State Board of Pharmacy's Affidavit of Intern Experience form.
1.3.5 The hours accrued during the College of Pharmacy Practical Experience Program may be applied to the 1500 hours total. These hours shall be recorded on the College Practical Experience form supplied by the Board. Registration as an intern in this State is not required for school experience.
1.3.6 An intern must notify the Board of Pharmacy in writing within ten (10) days of a change or preceptor. A change of preceptor affidavit must be completed and filed with the Board.
1.3.7 Applicants who have not completed all of the practical experience requirements, but who have graduated from an accredited college or have been certified by the NAPB Foreign Pharmacy Graduate Examination Committee are eligible to take the NAPLEX and/or MPJE examination. However, applicants will not be fully licensed until all the requirements of the licensing statute and regulations are completed. For more information on exam eligibility, please see Reg 1.2 or the Board's website at: http://www.dpr.delaware.gov/boards/pharmacy/newpharmacist.shtml.
1.4 Continuing Education Requirements
1.4.1 A pharmacist must acquire 3.0 C.E.U.'s (30 hours) per biennial licensure period. No carry over of credit from one registration period to another period is permitted. Each biennial licensure renewal period, the required 30 hours must include the following:
1.4.1.1 At least 2 hours of continuing education in the area of medication safety/errors and;
1.4.1.2 At least 2 hours of continuing education in:
1) the distribution, dispensing or delivery of controlled substances; or
2) the detection and recognition of symptoms, patterns of behavior, or other characteristics of impairment and dependency resulting from the abusive or illegal use of controlled substances.
1.4.2 Persons who are newly licensed after the registration period begins, must complete continuing education units proportional to the total number of continuing education units required for the biennial licensure renewal. (1.25 hours/per month).
1.5 Continuing Professional Educational Programs
1.5.1 Topics of Study shall be subject matter designed to maintain and enhance the contemporary practice of pharmacy.
1.5.2 Providers must be approved by ACPE.
1.5.3 A maximum of 2 credit hours will be awarded for First Aid, attendance at a Board of Pharmacy meeting and CPR/BCLS courses one time only per registration period.
1.5.4 Credit for Instructors of Continuing Education
1.5.4.1 Any pharmacist whose primary responsibility is not the education of health professionals, who leads, instructs or lectures to groups of nurses, physicians, pharmacists or others on pharmacy related topics in organized continuing education or inservice programs, shall be granted continuing education credit for such time expended during actual presentation, upon adequate documentation to the Delaware Board of Pharmacy.
1.5.4.2 Any pharmacist whose primary responsibility is the education of health professionals shall be granted continuing education credit only for time expended in leading, instructing, or lecturing to groups of physicians, pharmacists, nurses or others on pharmacy related topics outside his/her formal course responsibilities (that is, lectures or instructions must be prepared specifically for each program) in a learning institution.
1.5.4.3 Credit for presentations of in-service training programs or other lectures shall be granted only for topics meeting the criteria for continuing pharmacy education, and shall be granted only once for any given program or lecture. (Any topic completely revised would be eligible for consideration.)
1.5.4.4 A maximum of 6 hours (0.6 C.E.U.'s) in this category may be applied toward fulfilling the total biennial continuing education requirements.
1.5.5 Credit for On the Job Training:
1.5.5.1 The Board of Pharmacy does not as a general rule encourage the submission of "on the job training" for fulfilling the continuing education requirements. All programs meeting this definition shall be reviewed on an individual basis.
1.5.5.2 All programs that are submitted for credit must meet the criteria for continuing pharmacy education.
1.5.5.3 No credit shall be awarded for programs required by an employer for continued employment of the employee. (Examples OSHA training, Infection Control Education required by JCAHO.)
1.5.5.4 A maximum of 4 hours (0.4 C.E.U.'s) in this category may be applied toward fulfilling the total biennial continuing education requirements.
1.6 Audit of Continuing Education Hours
1.6.1 Audit. Each biennium, the Division of Professional Regulation shall randomly select from the list of renewed licensees a percentage of licensees, determined by the Board, to be audited. The Board may also audit based on complaints or charges against an individual license, relative to compliance with continuing education requirements or based on a finding of past non-compliance during prior audits.
1.6.2 Documentation. When a licensee is selected for audit, the licensee shall be required to submit documentation accounting for the continuing education hours claimed by the licensee. For ACPE-approved courses, the CPE log from NABP is acceptable documentation. For other courses, programs or activities, licensees selected for random audit are required to supplement the attestation with supporting materials which may include a syllabus, agenda, itinerary or brochure published by the sponsor of the activity and a document showing proof of attendance (i.e., certificate, a signed letter from the sponsor attesting to attendance, report of passing test score). The Board shall attempt to verify the continuing education shown on the documentation provided by the licensee. Upon completion of the review, the Board will decide whether the licensee's continuing education meets the requirements of these regulations.
1.6.2.1 Any continuing education not meeting all provisions of these regulations shall be rejected in part or in whole by the Board.
1.6.2.2 Any incomplete or inaccurate documentation of continuing education may be rejected in part or in whole by the Board.
1.6.3 Board Review and Hearing Process. The Board shall review all documentation requested of any licensee shown on the audit list. If the Board determines the licensee has met the requirements, the licensee's license shall remain in effect. If the Board initially determines the licensee has not met the requirements, the licensee shall be notified and a hearing may be held pursuant to the Administrative Procedures Act. This hearing will be conducted to determine if there are any extenuating circumstances justifying the apparent noncompliance with these requirements. Unjustified noncompliance of these regulations shall constitute a violation of 24 Del.C. §
2512(b) and may subject the licensee to discipline pursuant to 24 Del.C. §
2516.
1.6.4 Sanctions for Unjustified Noncompliance. The minimum penalty for the first finding of unjustified noncompliance shall be a $250.00 monetary penalty. However, the Board may impose any of the additional penalties specified in 24 Del.C. §
2516. The minimum penalty for the second finding of unjustified noncompliance shall be a $500 monetary penalty. However, the Board may recommend to the Board imposing any of the additional penalties specified in 24 Del.C. §
2516.
1.6.5 Requests for Extension- Extenuating Circumstances. A licensee applying for renewal may request an extension and be given up to an additional twelve (12) months to make up all outstanding required continuing education providing he/she can show good cause why he/she was unable to comply with such requirements at the same time he/she applies for renewal. The licensee must state the reason for such extension along with whatever documentation he/she feels is relevant. The Board shall consider requests such as extensive travel outside the United States, military service, extended illness of the licensee or his/her immediate family, or a death in the immediate family of the licensee. The written request for extension must be received by the Board prior to the licensure renewal. The Board shall issue an extension when it determines that one or more of these criteria have been met or if circumstances beyond the control of the licensee have rendered it impossible for the licensee to obtain the required continuing education. A licensee who has successfully applied for an extension under this paragraph shall make up all outstanding hours of continuing education within the extension period approved by the Board. Make-up credits may not be used in the next renewal period.
1.7 Reciprocal Requirements
1.7.1 An applicant for licensure by reciprocity shall meet the requirements of 24 Del.C. §
2510 and shall:
1.7.1.1 submit proof of licensure in good standing from each state where he or she is or has been licensed;
1.7.1.2 obtain a passing score on the MPJE on the laws applicable in this State as provided in subsection 1.2; and
1.7.1.3 get fingerprinted at your local police agency and have the original state and federal criminal history record or statement that there is no criminal history record sent directly to the Board office.
1.7.2 Reciprocity applicants who took examinations after June 1, 1979, must have passed the NAPLEX or an examination deemed equivalent by the Board and obtained scores required for applicants for licensure by examination.
1.7.3 Applicants who are licensed by reciprocity must begin accruing continuing education units at a rate of 1.25 hours/per month beginning with the month of licensure.
1.8 Late Renewal - If a pharmacist license or pharmacy permit expire for failure to renew before the deadline, the license or permit may be renewed at any time within the 60 days immediately following expiration upon application and payment of the renewal fee and a late fee. In accordance with 24 Del.C. §§
2507 and 2526, it is unlawful for a licensee or permittee to practice or operate while their license or permit is expired. All late pharmacist license renewals will be audited for compliance with the CE renewal requirement. While a pharmacist may renew his or her license within 60 days immediately following expiration of the license, all CE requirements must be met by the renewal deadline, which is September 30 of even years.
1.9 Duty to Update Address - Licensees must provide the Division of Professional Regulation with his/her current home mailing address. Any change in home mailing address must be reported to the Division within ten days of such change. All notifications and correspondence pertaining to a pharmacist's license that are sent through the mail will be sent only to the most recent address provided by the licensee. The failure to provide the Division with a current home mailing address will not operate to excuse any duty or responsibility of the licensee and confirmed delivery to the most recent address provided by the licensee will be considered proper notice.
1.10 Pharmacy Licenses. Pharmacy licenses shall include retail, hospital, nuclear and specialty institutional pharmacy licenses.
