(a) As used in this section, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent, and nondiscriminatory manner, such as an agency recognized for this purpose by the United States Department of Education.

1. (1) Each licensed pharmacist, required under article 130 of the Education Law to register with the department to practice in New York State, shall comply with the mandatory continuing education requirements as prescribed in subdivision (c) of this section, except those licensees exempt from the requirement or who obtain an adjustment to the requirement pursuant to paragraph (2) of this subdivision.

2. (2) Exemptions and adjustments to the requirement.

   1. (i) Exemption. Licensees who are not engaged in the practice of pharmacy, as evidenced by not being registered to practice in New York State, shall be exempt from the continuing education requirements, as prescribed in subdivision (c) of this section, except as otherwise provided in paragraph (c)(2) of this section to meet the education requirements for the resumption of practice after a lapse in practice for a licensee who has not lawfully practiced continuously in another jurisdiction throughout such lapse period.

   2. (ii) Adjustments to the requirement. An adjustment to the continuing education requirement, as prescribed in subdivision (c) of this section, shall be made by the department, provided that the licensee documents good cause that prevents compliance, which shall include but not be limited to, any of the following reasons: poor health certified by an appropriate health care professional; or extended active duty with the Armed Forces of the United States; or extreme hardship which in the judgment of the department makes it impossible for the licensee to comply with the continuing education requirements in a timely manner.

      (c) Mandatory continuing education requirement.

3. (1) During each triennial registration period, meaning a registration period of three years' duration, an applicant for registration shall complete at least 45 hours of formal continuing education acceptable to the department, as defined in paragraph (4) of this subdivision, provided that no more than 22 hours of such continuing education shall consist of self-study courses. During registration periods beginning on or after September 1, 2003, a licensee shall complete as part of the 45 hours of formal continuing education, or pro-ration thereof, at least three hours of formal continuing education acceptable to the department in the processes and strategies that may be used to reduce medication and/or prescription errors. Any licensee participating in collaborative drug therapy management pursuant to Education Law section 6801-a, shall complete as part of the 45 hours of formal continuing education, or pro-ration thereof, at least five hours of formal continuing education acceptable to the department in the area or areas of practice generally related to any collaborative drug therapy management protocols to which the pharmacist may be subject, provided that such continuing education shall not be completed as self-study.

4. (2) Requirement for lapse in practice.

   1. (i) A licensee returning to the practice of pharmacy after a lapse in practice, as evidenced by not being registered to practice in New York State, whose first registration date after such lapse in practice and following January 1, 1997 occurs less than three years from January 1, 1997, but on or after January 1, 1998, shall be required to complete:

      1. (a) at least one and one-quarter hours of acceptable formal continuing education for each month beginning with January 1, 1997 until the beginning of the new registration period, which shall be completed for a licensee who has not lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, in the 12-month period before the beginning of the new registration period; and for a licensee who has lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, in the new registration period or at the option of the licensee in the period beginning 36 months before the commencement of the new registration period and ending at the conclusion of such registration period; and
      2. (b) for a licensee who has not lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, at least 15 hours of acceptable formal continuing education in each successive 12-month period of the new registration period; and for a licensee who has lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, acceptable formal continuing education at the rate of one and one-quarter hours per month during the new registration period.

   2. (ii) Except as prescribed in subparagraph (i) of this paragraph for registrations therein specified, the licensee who returns to the practice of pharmacy after a lapse in practice in which the licensee was not registered to practice in New York State and did not lawfully practice pharmacy continuously in another jurisdiction throughout the lapse period, shall be required to complete:

      1. (a) the continuing education requirement applicable to the period of time the licensee was registered in the licensee's last registration period;
      2. (b) at least one and one-quarter hours of acceptable formal continuing education for each month of lapsed registration up to a maximum of 45 hours, which shall be completed in the 12 months before the beginning of the new registration period; and
      3. (c) at least 15 hours of acceptable formal continuing education in each succeeding 12-month period, after such registration is reissued, until the next registration date.

   3. (iii) Except as prescribed in subparagraph (i) of this paragraph for registrations therein specified, the licensee who returns to the practice of pharmacy after a lapse in practice in which the licensee was not registered to practice in New York State but did lawfully practice pharmacy continuously in another jurisdiction throughout the lapse period, shall be required to complete:

      1. (a) the continuing education requirement applicable to the period of time the licensee was registered in the licensee's last registration period;
      2. (b) at least one and one-quarter hours of acceptable formal continuing education for each month of lapsed registration up to a maximum of 45 hours, which shall be completed in the new registration period, or at the option of the licensee in the period beginning 36 months before the commencement of the new registration period and ending at the conclusion of the new registration period; and
      3. (c) completion of the regular continuing education requirement at the rate of one and one-quarter hours of acceptable formal continuing education per month during the new registration period.
5. (3) Proration. If a registration period is less than three years in duration, a licensed pharmacist shall complete acceptable formal continuing education at the rate of one and one- quarter hours of continuing education per month for such registration period.

6. (4) To be acceptable to the department, formal continuing education shall be formal courses of learning which contribute to professional practice in pharmacy:

   1. (i) in any one or more of the following curricular areas: pharmacology of new and developing drugs, or drug interactions, or public health issues, or infection control, or sterile procedures, or legal and regulatory issues, or patient counseling, or other topics which contribute to the professional practice in pharmacy as such practice is defined in section 6801 of the Education Law, or other matters of health care, law, and ethics which contribute to the health and welfare of the public; and

   2. (ii) obtained from a sponsor approved by the department pursuant to subdivision (h) of this section.

      (d) Renewal of registration.

      At each reregistration, licensed pharmacists shall certify to the department that they have either complied with the continuing education requirements, as prescribed in subdivision (c) of this section; or are subject to an exemption or adjustment to such continuing education requirements, as prescribed in subdivision (b) of this section.

      (e) Conditional registration.

7. (1) The department shall issue a conditional registration to a licensee who attests to or admits to noncompliance with the continuing education requirements of this section, provided that such licensee meets the following requirements:

   1. (i) the licensee agrees to remedy such deficiency within the conditional registration period;
   2. (ii) the licensee agrees to complete the regular continuing education requirement at the rate of one and one-quarter hours of acceptable formal continuing education per month during such conditional registration period; and
   3. (iii) the licensee agrees to complete additional continuing education during such conditional registration period, which the department may require to ensure the licensee's proper delivery of pharmaceutical care consistent with the licensee's practice of pharmacy.

8. (2) The duration of such conditional registration shall not exceed one year and shall not be renewed or extended.

   (f) Licensee records.

   Each licensee subject to this section shall maintain, or ensure access by the department to, a record of completed continuing education which includes: the title of the program, the number of hours completed, the sponsor's name and any identifying number, attendance verification, and the date and location of the program. Such records shall be retained for at least six years from the date of completion of the program and shall be available for review by the department in the administration of the requirements of this section.

   (g) Measurement of continuing education study.

   Continuing education credit shall be granted only for formal programs of learning that meet the requirements set forth in subdivision (c) of this section. A minimum of 50 minutes of study shall equal one hour of continuing education credit. For credit-bearing university or college courses, each semester-hour of credit shall equal 15 hours of continuing education credit, and each quarter-hour of credit shall equal 10 hours of continuing education credit.

   (h) Sponsor approval.

9. (1) To be approved by the department, sponsors of continuing education to licensed pharmacists shall meet the requirements of either paragraph (2) or (3) of this subdivision.

10. (2) The department shall deem approved as a sponsor of continuing education to licensed pharmacists:

    1. (i) a sponsor of continuing education that is approved by the American Council on Pharmaceutical Education or an equivalent organization determined by the State Board for Pharmacy to have equivalent standards for approving sponsors of continuing education for professionals regulated by title VIII of the Education Law; or
    2. (ii) a postsecondary institution for courses in programs that are registered pursuant to Part 52 of this Title or in equivalent programs that are accredited by an acceptable accrediting agency.

11. (3) Department review of sponsors.

    1. (i) The department shall conduct a review of sponsors that apply for approval to offer continuing education to licensed pharmacists and that are not deemed approved pursuant to the requirements of paragraph (2) of this subdivision.

    2. (ii) Organizations desiring to offer continuing education based upon a department re view under this paragraph shall submit, with the fee as set forth in subdivision (i) of this section, an application for advance approval as a sponsor at least 90 days prior to the date for the commencement of such continuing education that documents that the organization:

       1. (a) will offer courses of study in any one or more of the following curricular areas: pharmacology of new and developing drugs, or drug interactions, or public health issues, or infection control, or sterile procedures, or legal and regulatory issues, or patient counseling, or other topics which contribute to the professional practice in pharmacy as such practice is defined in section 6801 of the Education Law, or other matters of health care, law, and ethics which contribute to the health and welfare of the public;
       2. (b) is an organized educational entity, including but not limited to, a college of pharmacy; or a national, State, or local pharmacy association; or a hospital or health maintenance organization;
       3. (c) provides course instructors who are qualified to teach the courses which will be offered, including but not limited to, faculty of a college of pharmacy accredited by an acceptable accrediting agency; or instructors who are authorities in the health sciences specially qualified, in the opinion of the State Board of Pharmacy, to conduct such courses;
       4. (d) has a method of assessing the learning of participants, and describes such method; and
       5. (e) will maintain records for at least six years from the date of completion of coursework, which shall include, but shall not be limited to, the name and curriculum vitae of the faculty, a record of attendance of licensed pharmacists in such course work, an outline of the course of instruction, date and location of the coursework, and the number of hours for completion of the coursework. In the event an approved sponsor discontinues operation, the governing body of such sponsor shall notify the department and shall transfer all such records as directed by the department.
    3. (iii) Sponsors that are approved by the department pursuant to the requirements of this paragraph shall be approved for a three-year term.
    4. (iv) The department may conduct site visits of or request information from a sponsor approved pursuant to the requirements of this paragraph to ensure compliance with such requirements, and a sponsor shall cooperate with the department in permitting such site visits and in providing such information.

    5. (v) A determination by the department that a sponsor approved pursuant to the requirements of this paragraph is not meeting the standards set forth in this paragraph shall result in the denial or termination of the approved status of the sponsor.

       (i) Fees.

12. (1) At the beginning of each registration period, a mandatory continuing education fee of $45 shall be collected from licensees engaged in the practice of pharmacy in New York State, except for those exempt from the requirement pursuant to subparagraph (b)(2)(i) of this section. This fee shall be in addition to the registration fee required by section 6805 of the Education Law.
13. (2) Licensees applying for a conditional registration, pursuant to the requirements of subdivision (e) of this section, shall pay a fee that is the same as and in addition to, the fee for the triennial registration required by section 6805 of the Education Law. In addition, such licensees shall pay the $45 mandatory continuing education fee.
14. (3) Organizations desiring to offer continuing education to licensed pharmacists based upon a department review, pursuant to paragraph (h)(3) of this section, shall submit an application fee of $900 with its application for the issuance of a permit from the department to become an approved sponsor of a formal continuing education program. Application for a three-year renewal of the permit shall be accompanied by a fee of $900.

(b) Applicability of requirement.