RULES AND REGULATIONS
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Pharmacist Breaks
[39 Pa.B. 7005]
[Saturday, December 12, 2009]The State Board of Pharmacy (Board) amends §§ 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.
Description and Need for the Rulemaking
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.
The Board proposed 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 would 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 proposed 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 would not affect multiple pharmacists on duty taking staggered breaks. If only one pharmacist is on duty the pharmacist must remain in the building containing the pharmacy during the break. For pharmacies where the entire building is licensed this would not change current practice. However for pharmacies located in large retail establishments and institutions, the pharmacist shall remain in the immediate building. The term ''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 his 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 then 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 proposed 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 proposed 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.
Summary of Comments and Responses to Proposed Rulemaking
The Board published notice of proposed rulemaking at 38 Pa.B. 351 (January 19, 2008) with a 30-day public comment period. The Board received comments from the Pennsylvania Pharmacists Association (PPA), but from no other members of the public. The Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) as part of their review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12). The Board did not receive any comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC).
The PPA supported the proposed rulemaking.
The HPLC first questioned whether a break of 30 minutes is consistent with labor law and policies of the large pharmacies. The HPLC, joined by IRRC, also questioned whether the break was a single break or multiple breaks totaling up to 30 minutes throughout the entire shift. This rulemaking does not set standards for how often or for how long a pharmacy may or must permit a pharmacist to go on break; rather it provides the opportunity for a pharmacy to remain open when the sole pharmacist on duty is on a break of 30 minutes or less. Therefore, the amendment will not conflict with labor laws or policies.
The HPLC also questioned what protocol should be followed for requested counseling during a pharmacist's break. Would a customer seeking counseling from a pharmacist be expected to wait until the pharmacist returned from break, or would the pharmacist have to cut the break short. Proposed § 27.11(c)(1) provides that the pharmacist ''shall be accessible for emergencies or for counseling, if requested.'' The implication of this provision is that the pharmacist would return to the prescription area as needed during this period.
The Board has not found a need to revise its rulemaking in response to the comments. However, in the course of reviewing these comments, the Board noticed that the phrase ''while working in a pharmacy'' in § 27.11(c) was not consistent with the language of the general rule of that section. Accordingly, the Board has replaced this phrase with ''while the pharmacy is open.''
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have no adverse fiscal impact on the Commonwealth or its political subdivisions and will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
Effective Date
The final-form rulemaking will become effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
The final-form rulemaking is authorized under sections 4(2) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-4(j), 390-6(k)(1) and (9)).
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 9, 2008, the Board submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 351, to IRRC and 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 received 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 7, 2009, the final-form rulemaking was approved by the HPLC. On November 4, 2009, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 5, 2009, and approved the final-form rulemaking.
Additional Information
Persons who require additional information about the final-form rulemaking should submit inquiries to the Regulatory Unit Counsel, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649, or (717) 783-7156, or 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 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law and all comments were considered.
(3) The amendments to this final-form rulemaking do not enlarge the scope of proposed rulemaking published at 38 Pa.B. 351.
(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 §§ 27.11 and 27.16 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.
MICHAEL A. PODGURSKI, R.Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 6705 (November 21, 2009).)
Fiscal Note: Fiscal Note 16A-5420 remains valid for the final adoption of the subject regulations.
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
STANDARDS § 27.11. Pharmacy permit and pharmacist manager.
(a) A permit to conduct a pharmacy issued under section 4 of the act (63 P. S. § 390-4) shall show the name and address of the pharmacy, the name of the current owner and the name of the current pharmacist manager.
(b) A pharmacy may not display, advertise or use any name other than the name in which it is registered.
(c) 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 the pharmacy remains open 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.
(d) A change in name or ownership or controlling interest of the pharmacy shall require a new permit. Applications for new permits shall be filed within 30 days of the change in name, ownership or controlling interest.
(e) A person or entity holding a certificate, license, permit or registration as a licensed pharmacist or pharmacy may not post or display in public view a current certificate, license, permit, registration or renewal of a person not lawfully employed by the licensee.
(f) A pharmacy which closes or otherwise ceases operation shall immediately return to the Board its current permit and shall immediately inform the Board of the disposition of the prescription files and nonproprietary drugs. After 30 days, neither prescription files nor nonproprietary drugs may be sold, transferred or disposed of without prior permission from the Board. When a pharmacy closes or ceases operation, signs, symbols or other indications of a pharmacy shall immediately be removed from both the interior and exterior of the premises.
(g) If the pharmacist manager ceases to hold that position, the pharmacy permit holder shall inform the Board in writing of this fact and of the new pharmacist manager not more than 15 days later. If the Board does not object within 30 days of notification, the new pharmacist manager may be deemed approved. If the permit holder is unable to replace the pharmacist manager within those 15 days, the permit holder may request in writing an extension of up to 30 additional days to obtain a replacement. A pharmacy may not operate without a pharmacist manager for more than 15 days unless the pharmacy first obtains from the Board an extension of time for obtaining a replacement.
(h) A pharmacist may not serve as the pharmacist manager of more than one pharmacy at any given time. The holder of a permit to operate a pharmacy which has lost the services of a pharmacist manager and cannot obtain a suitable replacement may apply in writing to the Board for a temporary waiver of this subsection. The Board may grant a waiver which would authorize a pharmacist manager to serve as pharmacist manager of more than one pharmacy for up to 60 days after the initial 15 days permitted under subsection (g).
(i) Each pharmacy in this Commonwealth will require a separate permit regardless of ownership unless the pharmacy is a satellite pharmacy as defined in § 27.1 (relating to definitions).
§ 27.16. Construction and equipment requirements.
(a) Approval of plans. The following requirements are applicable to approval of plans:
(1) New pharmacy or change-of-location. Plans for construction of a new pharmacy or new location for an existing pharmacy may be submitted to the Board for approval prior to proceeding with construction. Within 90 days of receiving the plans, the Board will notify the applicant of its approval of the planned pharmacy or of its disapproval and the reasons for disapproval. The plans, including dimensions, must demonstrate compliance with applicable regulations and show the layout and fixtures for the prescription area and the immediately adjacent area.
(2) Alterations. The practice of pharmacy shall cease while substantial alterations in the layout or fixtures of an approved pharmacy are being made unless:
(i) The pharmacy makes the alterations and takes adequate precautions so that the health and safety of professionals, employees and the public is protected during the continuing operation of the pharmacy.
(ii) The plans for the alterations and a description of the precautions are submitted to the Board at least 30 days before the beginning of alteration work. If the Board raises no objection during that time, the pharmacy is authorized to proceed with the alterations as planned.
(b) Building standards. The following apply to building standards:
(1) Minimum size.
(i) The minimum size of the prescription area must be at least 250 square feet, and must be large enough, considering the level of activity, to carry on the practice of pharmacy in a manner that protects the health and safety of professionals, employees and the public. Within the prescription area, there must be a prescription working counter of at least 10 linear feet in length and 2 linear feet in width. If more than two pharmacists are on duty simultaneously, the minimum counter length shall be increased by 5 linear feet for an additional pharmacist. Institutions with special considerations may apply to the Board for a waiver.
(ii) A pharmacy operating as a central processing center need not conform to the minimum space requirements in subparagraph (i).
(2) Pharmacies in retail establishments. Pharmacies located within retail establishments whose business hours differ shall adhere to the following standards:
(i) The pharmacy can be securely sealed off from the remainder of the retail establishment.
(ii) The barrier devices which seal off the pharmacy must be capable of providing security for the pharmacy. The barrier devices must reach from floor to ceiling, shall be impenetrable by hand or the use of a reach extender, and be securely locked whenever a licensed pharmacist is not present and on duty.
(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).
(iv) Safes, electrical equipment or other facilities of the retail establishment may not be located in or approached through the pharmacy unless a pharmacist is on duty whenever staff from the retail establishment need access to these facilities.
(v) The hours of the pharmacy shall be posted at all points of public access.
(vi) Protocols for access to the pharmacy when it is closed by nonpharmacist staff for bona fide emergencies, such as fires, natural disasters or police matters, must include notification to the pharmacist manager.
(3) Locked compartment. Space shall be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances unless the pharmacy disperses controlled substances throughout the stock of noncontrolled substances in a manner that obstructs the theft of controlled substances. If the pharmacy stocks Schedule I controlled substances, these substances shall be stored in a securely locked, substantially constructed cabinet or safe.
(4) Telephone. At least one telephone shall be accessible in the prescription area, and the telephone number must be the telephone number printed on the prescription label.
(5) Sanitary facilities. Except for pharmacies operating as central processing centers, pharmacies shall be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. The sink must be connected properly to supply hot and cold water. Restroom facilities for employees of the pharmacy shall be provided reasonably close to, but outside of the prescription area.
(6) Lighting and ventilation. The pharmacy must be well lighted and ventilated.
(7) Television set. A television set may not be placed within the prescription area or so situated in the pharmacy that its viewing screen may be seen when looking at it from within the prescription area.
(8) Physical arrangement. The prescription area must be arranged so that prescription drugs and devices are inaccessible to an unlicensed or unauthorized person. The prescription area may not be used for storage of merchandise or other items other than those used in the preparation, dispensing or delivery of drugs. Animals may not be allowed in a prescription area except for security reasons.
(9) Existing pharmacies. Existing pharmacies licensed by the Board prior to the effective date of this chapter may continue if they reasonably conform, or are made to reasonably conform, to the intent of this chapter. The Board will determine what constitutes reasonable conformity consonant with the public interest, health, safety and welfare.
[Pa.B. Doc. No. 09-2277. Filed for public inspection December 11, 2009, 9:00 a.m.]
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