RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Pharmacy Internship
[44 Pa.B. 7552]
[Saturday, December 6, 2014]The State Board of Pharmacy (Board) amends § 27.26 (relating to pharmacy internship) to read as set forth in Annex A.
Effective Date
The final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
The final-form rulemaking is authorized under sections 3(c) and 6(k)(9) of the Pharmacy Act (act) (63 P. S. §§ 390-3(c) and 390-6(k)(9)).
Background and Purpose
Section 3(c) of the act requires that ''[t]o insure proficiency in the practical aspects of pharmacy, the board shall, by regulation, prescribe internship requirements which must be satisfactorily completed prior to issuance of a pharmacist license.'' Section 27.26 sets forth standards for the pharmacy internship. In addition to graduation from an Accreditation Council for Pharmacy Education (ACPE) accredited pharmacy degree program and successful completion of the licensure examination, completion of an internship prepares the applicant to function competently and effectively upon licensure. The current trend in pharmacy education is for greater participation by students in an academic internship as part of the educational process. This final-form rulemaking permits a pharmacy intern to complete more of the internship requirements through academic internships or nontraditional internships. Additionally, this final-form rulemaking assures that only those aspiring pharmacists who continue the path to licensure will be permitted to continue to work as pharmacy interns.
Summary of Comments and Responses to Proposed Rulemaking
The Board published a proposed rulemaking at 42 Pa.B. 5353 (August 18, 2012) with a 30-day public comment period. The Board received comments from the following commentators: Heather J. Johnson, Pharm.D., BCPS, Assistant Professor, University of Pittsburgh School of Pharmacy; Brian A. Potoski, R.Ph., Pharm.D., Associate Professor, University of Pittsburgh School of Pharmacy; Mary Elizabeth Ray, B.S.Pharm., Pharm.D., Director, Office of Experiential Education, LECOM School of Pharmacy; Hershey S. Bell, M.D., M.S., FAAFP, Professor, Vice President for Academic Affairs and Dean, LECOM School of Pharmacy; and the Pennsylvania Pharmacists Association (PPA). The Board also received comments from the Independent Regulatory Review Commission (IRRC) as part of the review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12a). On October 3, 2012, the House Professional Licensure Committee (HPLC) voted to not take formal action on the proposed regulation until the final regulation is promulgated. The Board did not receive comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC).
The comments were discussed at the public meeting of the Board on September 17, 2013. Present during the discussion of the comments were representatives from Target, Acme, PPA, the Hospital and Healthsystem Association of Pennsylvania, CVS Caremark and Giant. These stakeholders did not offer additional comment during discussion of the written comments.
The comments from Heather J. Johnson, Brian A. Potoski, Hershey S. Bell and PPA were supportive of the amendments and did not offer changes to the proposed rulemaking. Mary Elizabeth Ray was supportive of the proposed amendments and hoped that the Board would, in the future, eliminate the requirement in § 27.19 (relating to prospective drug review and patient counseling) that only a pharmacist may counsel. While not adding that change to this final-form rulemaking, the Board considered the comment and plans to address patient counseling by interns in an upcoming ''general revisions'' rulemaking, which is currently being drafted.
IRRC expressed concern regarding § 27.26(b)(2) where the Board requires documentation from the ACPE-accredited pharmacy degree program (program) to include the student's Social Security number. At the outset, the Board notes that this information has been collected on the intern application for many years from both the student and the program. The Board is merely codifying the information it has traditionally requested on the application. Currently, Section E of the intern application requests this information from the program. However, if the program were to send a letter instead of completing Section E, the program has notice of what information needs to be on the letter for the Board to process it and match it with the other parts of the intern application. IRRC also asked why the Board is not directly asking the student to produce the Social Security number. Section A of the application, which is completed by the student, asks the student to provide the Social Security number. The Board is required under section 466(a)(13)(A) of the Social Security Act (42 U.S.C.A. § 666(a)(13)(A)) to collect this information to comply with requirements regarding child support enforcement as implemented in this Commonwealth by 23 Pa.C.S. § 4304.1(a) (relating to cooperation of government and nongovernment agencies). In fact, the Commonwealth previously applied under section 6 of the Social Security Number Privacy Act (71 P. S. § 2606) to the United States Department of Health and Human Services for an exemption from the requirement. However, in a letter from Margot Bean, Commissioner of the Office of Child Support Enforcement within the United States Department of Health and Human Services dated July 28, 2008, the exemption was denied as to applications for professional and occupational licenses (although it was granted as to recreational licenses).
Additionally, the Board is required to collect Social Security numbers to comply with the mandatory reporting requirements of the Federal National Practitioner Data Bank. Under regulations of the United States Department of Health and Human Services in 45 CFR Part 60 (relating to National Practitioner Data Bank), the Board is required to report disciplinary actions taken against licensees and registrants to the National Practitioner Data Bank. Specifically, 45 CFR 60.9(b)(1)(ii) (relating to reporting licensure and certification actions taken by states) requires the reporting of the individual's Social Security number when reporting adverse actions taken by health-related licensing authorities.
For these reasons, the following notice is found on applications, including the application for intern registration:
Disclosing your Social Security number on this application is mandatory in order for the Pennsylvania State Board of Pharmacy to comply with the requirements of the federal Social Security Act pertaining to child support enforcement, as implemented in the Commonwealth of Pennsylvania at 23 Pa.C.S. § 4304.1(a). In order to enforce domestic child support orders, the Commonwealth's licensing boards must provide to the Department of Public Welfare (DPW) information prescribed by DPW about the licensee, including the Social Security number. Additionally, disclosing the number is mandatory in order for this board to comply with the reporting requirements of the federal National Practitioner Data Bank (NPDB). Reports to the NPDB must include the individual's Social Security number.IRRC further asked what capacity the Board has to verify the Social Security number. The Board asks the program to provide the Social Security number as a way to match that portion of the application with the portion submitted directly by the student. As the two portions of the application do not come to the Board office together, the Board must be able to match the program portion of the application with the student portion of the application. The Board receives many intern applications, and applicants can have the same name or birth date. The Social Security number is the best means of matching the two portions of the application.
IRRC also expressed concern about how the Board will internally secure this documentation to protect the student from identity theft. The Board will secure the student's Social Security number as it does all confidential information received from licensees. The information is entered into the licensing system. The Board scans the application and stores the document electronically in the licensing system. The paper applications are then placed in locked recycle bins and sent for confidential shredding. The Board is also transitioning its applications to online forms. The information goes directly into the licensing system when the online forms are received.
IRRC asked whether the program possesses the student's Social Security number and whether the Board would deny an internship to a student if the Social Security number is not disclosed by or available to the program. In the Board's experience, programs generally have the student's Social Security number. In the rare circumstance that a program may not have a student's Social Security number, it has been able to obtain it once notified that it is required. An application that is missing a Social Security number is not denied. It is held as pending until the Social Security number is provided.
Upon review of the proposed rulemaking and comments the Board noticed that in § 27.26(l) it had omitted an amendment to delete ''certificate'' and replace it with ''registration.'' In the final-form rulemaking, the Board changed this term to comport with the change in terminology made in the proposed rulemaking. No other changes were made to the annex in the final-form rulemaking.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will not have adverse fiscal impact on the Commonwealth or its political subdivisions. Because the information required under § 27.26 is already collected by the Board, this final-form rulemaking does not impose additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 8, 2012, the Board submitted a copy of the notice of proposed rulemaking, published at 42 Pa.B. 5353, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on October 22, 2014, the final-form rulemaking was deemed approved by the HPLC and the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on October 23, 2014, and approved the final-form rulemaking.
Additional Information
Persons who require additional information about the final-form rulemaking should submit inquiries to Board Counsel, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7156, st-pharmacy@state.pa.us.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and the comments were considered.
(3) The amendments to this final-form rulemaking do not enlarge the scope of proposed rulemaking published at 42 Pa.B. 5353.
(4) The final form rulemaking adopted by this order is necessary and appropriate for the administration of the act.
Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending § 27.26 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of Attorney General and the Office of General Counsel for approval as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) The final-form rulemaking shall take effect upon publication in the Pennsylvania Bulletin.
THERESA M. TALBOTT, R.Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 44 Pa.B. 7145 (November 8, 2014).)
Fiscal Note: Fiscal Note 16A-5424 remains valid for the final adoption of the subject regulation.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
PHARMACISTS § 27.26. Pharmacy internship.
(a) Pharmacy internship means the supervised practical experience required for licensure as a registered pharmacist. The purpose of the pharmacy internship program is to provide a registered intern with the knowledge and practical experience necessary for functioning competently and effectively upon licensure.
(b) Registration as a pharmacy intern will be available to an individual of good moral character who has completed at least 2 years of college and is enrolled or accepted as a student of pharmacy in an ACPE-accredited pharmacy degree program. A person desiring to register as a pharmacy intern shall do the following:
(1) Apply to the Board for registration including the fee specified in § 27.91 (relating to schedule of fees) for registering as a pharmacy intern.
(2) Forward to the Board acceptable documentation verifying that the applicant has successfully completed at least 2 years of college and is enrolled or accepted as a student of pharmacy in an ACPE-accredited pharmacy degree program. Acceptable documentation includes a document bearing the school's seal received by the Board directly from the dean or registrar of the ACPE-accredited pharmacy degree program which includes the pharmacy student's name, address, Social Security number, and a statement indicating that the student has successfully completed at least 2 years of college and is enrolled or accepted as a student of pharmacy in, or has graduated from, the ACPE-accredited pharmacy degree program.
(c) The Board will register an applicant after it receives a completed application and other items in subsection (b). A pharmacy intern registration is valid for 6 years from the date of issue exclusive of time spent in the military. A pharmacy intern registration will automatically become invalid if the pharmacy intern permanently ceases enrollment in an ACPE-accredited pharmacy degree program prior to graduation. A pharmacy intern whose registration becomes invalid under this subsection shall immediately return to the Board the pharmacy intern registration and preceptor approval documents.
(d) The following applies to internship credit:
(1) An intern shall serve at least 1,500 hours.
(2) A maximum of 50 hours may be credited in 1 week.
(3) An intern shall serve at least 500 of the 1,500 hours in a pharmacy.
(4) An intern may earn up to 1,000 of the 1,500 hours in an internship program sponsored or approved by an ACPE-accredited pharmacy degree program.
(5) The Board may grant internship credit for hours that an individual served in a pharmacy before the individual registered as an intern only if the individual shows good cause for failing to register in timely fashion.
(6) The Board will not grant internship credit for hours which an individual served in a pharmacy if the supervising pharmacist was not registered as a preceptor. An exception to the requirement that the supervising pharmacist register as a preceptor will be made for internship hours acquired in an internship program sponsored or approved by an ACPE-accredited pharmacy degree program.
(e) The Board will grant internship credit only for activities related to the practice of pharmacy. The following are examples of these activities: scrutinizing prescriptions or drug orders, taking oral orders for prescriptions by telephone or otherwise, compounding medications and filling prescriptions. The Board will not grant internship credit for activities which are not related to the practice of pharmacy.
(f) An intern who wishes to receive credit for internship experience that is not in a pharmacy or sponsored or approved by an APCE-accredited pharmacy degree program shall apply to the Board for approval before beginning an internship experience. Upon receipt of the application, the Board will review and determine how much, if any, credit will be given. Requests for approval shall be submitted at least 90 days before the internship experience begins. Credit given for a nontraditional internship may not be used to satisfy the requirement of subsection (d)(3) pertaining to the minimum amount of time the internship shall be served in a pharmacy.
(g) A person may not be eligible to become a candidate for registration to practice pharmacy unless the person receives instruction in practical pharmacy and pharmaceutical technique from an instructor, professor or faculty member who is a registered pharmacist or from a faculty member who is a registered pharmacist at an ACPE-accredited pharmacy degree program.
(h) The following requirements are applicable to a pharmacy utilized for intern training:
(1) A pharmacy may not have been or be in violation of Federal, State or municipal statutes and ordinances governing any phase of activity in which it is engaged. A pharmacy may appeal to the Board for a waiver of this provision.
(2) A pharmacy shall be managed so that the emphasis is on activities connected with the distribution of articles and services pertaining to medical care, including drugs, medicines, prescriptions, medical supplies and materials.
(3) A pharmacy shall be kept in a sanitary, orderly and clean condition, and the prescription department shall meet the requirements in the statutes and regulations as they affect prescription departments.
(4) A pharmacy shall compound and dispense a sufficient number of prescriptions including renewals so as to provide the pharmacy intern with ample opportunity to scrutinize prescriptions and to compound and dispense under the supervision of a licensed pharmacist.
(5) A pharmacy shall have in its employ a licensed pharmacist who is registered as a pharmacist preceptor.
(6) A pharmacy which meets the qualifications of this section shall be approved by the Board after proper notification by the owner or manager of willingness to cooperate in the development of the internship program. Whenever a new intern is accepted for training in the pharmacy, the pharmacist preceptor shall notify the Board of the name of the intern and his anticipated period of internship in the pharmacy.
(i) The requirements for registration as a pharmacist preceptor are as follows:
(1) A pharmacist preceptor may not have been convicted of a criminal offense relating to the practice of pharmacy.
(2) An applicant shall hold a license without restriction to practice pharmacy in this Commonwealth and shall be engaged in the active practice of pharmacy in this Commonwealth.
(3) An applicant shall be working on a full-time basis in a pharmacy utilized for intern training.
(4) A pharmacist preceptor may not direct the training of more than two pharmacy interns at any one time, unless the program has been approved by the Board for a greater number.
(5) A pharmacist preceptor shall be willing to cooperate with the Board in developing an intern program and shall apply to the Board signifying the desire to do so.
(6) A pharmacist preceptor shall certify to the commencement and completion of intern training and may make recommendations to the Board concerning the competency of the intern under his supervision.
(7) A pharmacist preceptor shall report to the Board, as required by the Board, on the progress of an intern under the pharmacist's supervision.
(8) A pharmacist preceptor shall be charged with the responsibility for seeing that his intern receives proper pharmaceutical training and experience, always keeping in mind the objections of the practical training program.
(j) Credit will be granted for practical experience gained in pharmacies outside this Commonwealth upon presentation of evidence satisfactory to the Board to indicate that the experience gained is substantially equivalent to that required by this chapter.
(k) The pharmacy internship may not be deemed satisfactorily completed until the intern has filed affidavits with the Board certifying that the intern has obtained a total of 1,500 hours of practical experience since registration as a pharmacy intern.
(l) When a candidate receives his first certificate and identification card to practice as a pharmacist, his registration as an intern terminates.
[Pa.B. Doc. No. 14-2505. Filed for public inspection December 5, 2014, 9:00 a.m.]
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