PROPOSED RULEMAKING
[49 PA. CODE CH. 27]
Pharmacist Breaks
[38 Pa.B. 351]
[Saturday, January 19, 2008]The State Board of Pharmacy (Board) proposes to amend §§ 27.11 and 27.16 (relating to pharmacy permit and pharmacist manager; and construction and equipment requirements) to read as set forth in Annex A. The proposed rulemaking would set standards for a pharmacist to take a 30-minute break, but still be available for emergencies or counseling if needed.
Effective Date
The amendments will be effective upon final-form publication in the Pennsylvania Bulletin.
Statutory Authority
The amendments are authorized under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-(4)(j) and 390-6(k)(1) and (9)).
Background and Need for Amendment
Currently, the Board does not have regulations pertaining to when and how a sole pharmacist on duty may take a break while the pharmacy remains open. The Board's regulations only state that a pharmacy may not be open without a licensed pharmacist present and on duty. This has created a disparity among different types of pharmacies. In traditional ''drug stores'' the entire building is licensed as a pharmacy, therefore a pharmacist may take a break anywhere in the store and still be in the pharmacy. However, in large retail establishments only the area containing the pharmacy is licensed. Retail establishments include large wholesale stores, grocery stores and retail stores. Because the regulation mandates that the pharmacy must be closed when the pharmacist is not present in the pharmacy, the pharmacy must close if the pharmacist leaves the pharmacy to take a break in another area of the retail store. This has put retail establishments at a disparity with the more traditional drug stores.
Description of Proposed Amendments
The Board proposes to amend § 27.11(c) to state that the prescription area of a pharmacy may not be open without a licensed pharmacist on duty at all times. This is to clarify that the retail area in a traditional drug store where the whole building is licensed as a pharmacy may still be open when the prescription area is closed. The prescription area is already defined in § 27.1 (relating to definitions) as the area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy. The term prescription area does not include waiting counters or display space attached to the waiting counters. The Board also proposes to amend § 27.11(c) to allow a sole pharmacist on duty in a pharmacy to take up to a 30-minute break. The proposed amendment does not affect multiple pharmacists on duty taking staggered breaks. If only one pharmacist is on duty, the pharmacist shall remain in the building containing the pharmacy during the break. For pharmacies where the entire building is licensed this does not change current practice. However for pharmacies located in large retail establishments and institutions, the pharmacist shall remain in the immediate building. The immediate building is defined as the physical structure that contains the pharmacy. For example in a large retail, wholesale or grocery store, the pharmacist shall remain in that store. In an institution, the pharmacist shall remain in the building containing the pharmacy, so that in institutions on a campus with multiple buildings, the pharmacist could not go to another building during a break. Pharmacies located in malls are not included in the class of pharmacies that only have a portion of the store licensed, as those pharmacies are typically the traditional retail pharmacy where the entire store is licensed. If a large retail establishment with a pharmacy inside is attached to a mall, the restriction that the pharmacist shall remain in the retail establishment applies. The pharmacist should not leave the store to go into the mall while the pharmacy remains open.
The Board proposes to add § 27.11(c)(2) to allow a pharmacy to remain open during a sole pharmacist's break to receive new written prescriptions, prepare prescriptions for final verification by the pharmacist and to deliver prescription medications that have already been verified by the pharmacist.
Finally, the Board proposes to amend § 27.16(b)(2)(iii) to cross reference § 27.11(c)(1) and add and define the term ''immediate building.''
With the implementation of these standards, the Board intends to allow pharmacists to take breaks as needed while still being available for counseling or other emergencies. The public is protected because while the pharmacist is away from the pharmacy, no prescriptions could be delivered to a patient that were not first verified by the pharmacist; however new written prescriptions could be accepted and pharmacy technicians and pharmacy interns may prepare prescriptions for final verification.
Fiscal Impact
The proposed amendments will have no fiscal impact on the Board or the regulated community.
Paperwork Requirements
The proposed amendments will impose no paperwork requirements on the Board or the regulated community.
Sunset Date
The Board monitors its regulations on an ongoing basis. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (act) (71 P. S. § 745.5(a)), on January 9, 2008, the Board submitted a copy of these proposed amendments and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the act, IRRC may convey any comments, recommendations or objections regarding the proposed amendments within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria that have not been met. The act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly, and the Governor of comments, recommendations or objections raised.
Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding this proposed rulemaking to Melanie Zimmerman, Executive Secretary, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649, within 30 days following publication of this proposed amendments in the Pennsylvania Bulletin.
EDWARD J. BECHTEL, R.Ph.,
ChairpersonFiscal Note: 16A-5420. No fiscal impact; (8) recommends adoption.
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
GENERAL PROVISIONS § 27.11. Pharmacy permit and pharmacist manager.
* * * * * (c) [A] The prescription area of a pharmacy may not be open without a licensed pharmacist on duty at all times. A sole pharmacist on duty may take up to a 30-minute break while working in a pharmacy consistent with the following:
(1) The pharmacist shall remain in the pharmacy or, in the case of a pharmacy located within a retail establishment or institution, in the immediate building containing the pharmacy, and shall be accessible for emergencies or for counseling, if requested. For purposes of this paragraph, the term ''immediate building'' means the physical structure that contains the pharmacy. A pharmacy located at a complex consisting of multiple retail and other business establishments, such as a mall, is not considered to be ''located within a retail establishment.'' In that case, the entire store containing the pharmacy is licensed, and the pharmacist shall remain in the store during a break.
(2) The pharmacy may remain open during the pharmacist's break for patient-related services, including:
(i) The receipt of new written prescriptions.
(ii) The preparation of prescriptions for final verification by the pharmacist.
(iii) The delivery of prescription medications that have been verified by the pharmacist.
* * * * * § 27.16. Construction and equipment requirements.
* * * * * (b) Building standards. The following apply to building standards:
* * * * * (2) Pharmacies in retail establishments. Pharmacies located within retail establishments whose business hours differ shall adhere to the following standards:
* * * * * (iii) The pharmacy shall be closed whenever a licensed pharmacist is not present in the immediate building and on duty. For purposes of this section, the term ''immediate building'' has the same meaning given to it in § 27.11(c)(1) (relating to pharmacy permit and pharmacist manager).
* * * * *
[Pa.B. Doc. No. 08-93. Filed for public inspection January 18, 2008, 9:00 a.m.]
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