Section 1330.300  Approval of Pharmacy Programs

a)         The Division shall, upon the recommendation of the Board, approve a pharmacy program in a school or college or department of pharmacy of a university or other institution as reputable and in good standing if it meets the following minimum criteria:

1)         Is legally recognized and authorized, through appropriate agencies such as a ministry of education or higher education governing board, by the jurisdiction in which it is located to confer a first professional degree in pharmacy;

2)         Has a faculty comprised of a sufficient number of full-time instructors to make certain that the educational obligations to the student are fulfilled.  Their facility must have demonstrated competence in their area of teaching as evidenced by appropriate degrees from professional colleges or institutions in disciplines reflective of the curricular requirements.  (All of the pharmacist members of the clinical faculty and a majority of the faculty in the pharmaceutical sciences should be licensed pharmacists in that jurisdiction.  The clinical faculty should be active practitioners.);

3)         Has a curricular offering of post-secondary instruction totaling at least 5 academic years, including any preprofessional education requirements, and requiring a minimum of the following subject areas:

A)        General Education (a minimum of 30 semester hours or its equivalent in courses in the humanities and behavioral and social sciences);

B)        Preclinical Sciences (courses in the physical and biological sciences and mathematics that are prerequisites to professional studies and training; course work should include general chemistry, organic chemistry, general biology, microbiology and mathematics);

C)        Professional Studies and Training (in the following areas):

i)          Biomedical sciences, which include anatomy, physiology, immunology, biological chemistry, pathology and biostatistics;

ii)         Pharmaceutical sciences, which include pharmaceutical or medicinal chemistry, pharmaceutics or dosage form design and evaluation, pharmacokinetics, synthetic and natural drug product chemistry, pharmacology, pharmaceutical administration and the social and behavioral sciences in pharmacy;

iii)        Clinical sciences and practice, which include clinically applied courses based on the biomedical and pharmaceutical sciences, such as didactic courses in clinical foundations, disease processes and diagnoses, clinical pharmacology and therapeutics, and drug information research and literature retrieval; and

iv)        Externship and clerkship, which include a minimum of 400 direct contact hours in clerkship and externship experience.  These experiences should minimally include supervised training in inpatient environments providing for interdisciplinary experiences with other health professionals and distributive aspects of pharmacy practice;

4)         Has essential facilities including, but not limited to, administrative and faculty offices, teaching and research laboratories, lecture rooms, conference rooms, student activities areas, service areas and other programmatic support areas;

5)         Has a comprehensive library that contains a contemporary collection of periodicals, texts and reference books relevant to the biomedical, pharmaceutical and clinical aspects of health care and its systems of delivery;

6)         Has clinical facilities adequate in number and quality and with appropriate supervision to deliver the clinical clerkships and externships of the curriculum.  The facilities shall be available in inpatient and outpatient environments, including patient care areas of health care institutions, hospital pharmacies and community pharmacies; and

7)         Maintains permanent retrievable and auditable student records that summarize the credentials for admission, attendance, grades and other records of performance for each student enrolled in the program.

b)         In determining whether a school or college should be approved, the Division shall take into consideration, but not be bound by, accreditation standards established by the Accreditation Council on Pharmacy Education.

c)         An applicant from a pharmacy program that has not been evaluated shall cause to be forwarded to the Division documentation concerning the criteria in this Section.  If the documentation is insufficient to evaluate the program, the applicant will be required to provide such additional information as necessary.  Once the Division has received the documentation or after 6 months have elapsed from the date of application, whichever is first, the Board will evaluate the program based on all documentation received from the school and any additional information the Division has received that will enable the Board to evaluate the program based on the criteria specified in this Section.  In the event the program is not approved as reputable and in good standing by the Division, applicants from the program must successfully complete the preliminary diagnostic examination and all other requirements set forth in the Act and this Part.

d)         The Director shall, upon written recommendation of the Board, withdraw, suspend or place on probation the approval of a pharmacy program when the Director determines, based upon the report of the Board, the quality of the program has been materially affected.  In determining the existence of a material effect, the Board and the Director shall consider:

1)         Gross or repeated violations of any provision of the Act;

2)         Gross or repeated violations of any provision of this Part;

3)         Fraud or dishonesty in furnishing documentation for evaluation of the pharmacy program; or

4)         Failure to continue to meet the established criteria for an approved pharmacy program set out in this Section.

e)         When approval of a pharmacy program is being reconsidered by the Division, written notice shall be given at least 15 days prior to any recommendation by the Board, and the officials in charge may either submit written comments or request an interview before the Board.

f)         The Division, upon the recommendation of the Board, has determined that all pharmacy programs accredited by the Accreditation Council on Pharmacy Education as of July 1, 2007 meet the minimum criteria set forth in subsection (a) and are, therefore, approved.  The Board shall review the list of accredited programs published each year on July 1 by the Accreditation Council on Pharmacy Education in order to determine whether the programs continue to meet the minimum criteria.