RULES AND REGULATIONS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Approval of Plans: Pharmacy Alterations
[27 Pa.B. 6218] The State Board of Pharmacy (Board) amends § 27.16 (relating to construction requirements) to read as set forth in Annex A. The object of this amendment is to codify the Board's determination that two standards in the existing regulations are unnecessary and overly burdensome.
The first standard concerns the required Board approval to operate a pharmacy during alterations to the layout or fixtures of a pharmacy in § 27.16(a)(2).
The Board has entertained commentary from spokespersons for the regulated community about its standards relating to the deadline to submit plans for changes in existing pharmacies to the Board. Currently, pharmacies must give 90 days advance notice to the Board before alterations or renovations in layout or fixtures can be undertaken. Representatives of pharmacies provided the Board with an explanation of the difficulties posed by the 90 days' advance notice. A reduced time frame is more responsive to current demands on businesses' financing and construction planning.
The Board granted commentators' request to reduce the advance time frame notice to 30 days, and has directed its agents appropriately with regard to the issuance of citations for violations of the Pharmacy Act (63 P. S. §§ 390-1--390-13) and regulations. Accordingly, in this amendment, the Board revises the 90-day notice requirement in § 27.16(a)(2)(ii) to require pharmacies to submit plans for alterations only 30 days in advance of the beginning of renovation construction.
The second standard concerns the suggested ratio of prescription area to store size in the building standards of § 27.16(b)(2). The ratio was developed in 1973, and was established solely as a guideline and not a regulatory requirement. In the proposed rulemaking published at 26 Pa.B. 1032 (March 9, 1996), the Board in a notice of proposed rulemaking containing general revisions proposed deleting the ratio in its entirety. No comments were received pertaining to the deletion.
The Board has not concluded its preparation of the general revisions rulemaking, but has determined to proceed expeditiously with the deletion of the size guidelines. By this amendment, the Board is deleting the current version of § 27.16(b)(2). The Board will then omit that section from the general revisions rulemaking. As stated in the voluntary guidelines, this subsection was intended to reflect the Board's experience at that time that a direct relationship existed between the overall retail floor space of a pharmacy and the amount of prescriptions compounded and dispensed from the pharmacy itself. The Board no longer believes that there is a significant relationship between the size of a retail store and the level of activity in a pharmacy. Pharmacists and pharmacy owners are competent to make decisions determining the appropriate size of a prescription area on the basis of their professional and business experience. Moreover, the Board finds placing voluntary guidelines in a regulatory format unnecessarily confusing to pharmacy owners.
Public notice of intention to amend the Board's regulations under the procedures specified in sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) (CDL) has been omitted as authorized under section 204(3) of the CDL (45 P. S. § 1204(3)), because the Board finds that these procedures are, under the circumstances, unnecessary and impracticable. The guidelines in § 27.16(b)(2) were not enforced and provided pharmacies with no meaningful regulatory standards. The 90-day deadline in § 27.16(a)(2)(ii) was more responsive to management and administrative needs of the Board and its agents than to the needs of the regulated community. The Board has therefore determined that its continued enforcement is contrary to the public interest.
Compliance with Executive Order 1996-1
The Board reviewed this rulemaking and considered the purpose and likely impact upon the public and the regulated population under the directives of Executive Order 1996-1, Regulatory Review and Promulgation. The final/proposed omitted regulation addresses a compelling public interest as described in this Preamble and otherwise complies with Executive Order 1996-1.
Statutory Authority
This amendment is authorized under sections 4(j) and 6(k)(9) of the Pharmacy Act (63 P. S. §§ 390-4(j) and 390-6(k)(9)).
Fiscal Impact and Paperwork Requirements
The amendment will have no fiscal impact on the Commonwealth or its political subdivisions. Although it cannot by quantified, individual pharmacies and the regulated community should experience greater flexibility in planning which the Board anticipates will result in savings.
Regulatory Review
Under section 5.1(c) of the Regulatory Review Act (71 P. S. § 745.5a(c)), on October 8, 1997, a copy of the amendment was submitted to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the Senate Committee on Consumer Protection and Professional Licensure and the House Committee on Professional Licensure. In addition, the amendment was submitted to the Office of Attorney General for review and comment under the Commonwealth Attorneys Act (71 P. S. §§ 732-101--732.506).
Under section 5.1(d) and (e) of the Regulatory Review Act, the amendment was deemed approved by the House and Senate Committees on October 28, 1997, and by IRRC on November 6, 1997.
Additional Information
Individuals who desire information are invited to submit inquiries to W. Richard Marshman, Executive Secretary, State Board of Pharmacy, Post Office Box 2649, Harrisburg, PA 17105-2649, (717) 783-7157.
Findings
The Board finds that:
(1) Public notice of intention to amend its regulations as adopted by this order, under the procedures specified in sections 201 and 202 of the CDL, has been omitted under the authority contained in section 204(3) of the CDL (45 P. S. § 1204(3)). The Board has, for good cause, found that the procedures specified in sections 201 and 202 of the CDL are, in this circumstance, unnecessary, impracticable and contrary to the public interest.
(2) The amendment of the regulations of the Board in the manner provided in this order is necessary and appropriate for the administration of its authorizing statute.
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 § 21.16 to read as set forth in Annex A, with ellipses referring to the existing text of the regulation.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as to legality as required by law.
(c) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall become effective immediately upon publication in the Pennsylvania Bulletin.
PAULA L. CASTOR, R.Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 27 Pa.B. 6128 (November 22, 1997).)
Fiscal Note: 16A-546. 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
STANDARDS § 27.16. Construction requirements.
(a) Approval of plans. The following requirements shall be applicable to approval of plans:
* * * * * (2) Alterations. The practice of pharmacy shall cease while substantial alterations in the layout of fixtures of an approved pharmacy are being made unless:
(i) The pharmacy makes the alterations and takes adequate precautions in such a manner that the health and safety of professionals, employes and the public shall be 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. The minimum size of the prescription area shall be not less than 250 square feet, but shall 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, employes and the public. Within the prescription area, there shall be a prescription working counter of not less than 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.
(2) Adjoining store. A permit may be issued for a self-contained pharmacy having an entrance into an adjoining store which owns the pharmacy or is otherwise affiliated with it. The pharmacy shall have an area of at least 350 square feet. Its separating walls and doors shall afford a degree of security against illegal entry equal to that normally afforded by walls and doors fronting on a public way, and the doors shall be securely locked whenever a licensed pharmacist is not present and on duty. The terms ''pharmacy,'' ''drugs'' or words of comparable meaning may only be used in reference to the self-contained pharmacy.
(3) Locked compartment. Space shall be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances required to be kept locked in accordance with Federal BNDD regulations.
(4) Telephone. At least one telephone--or more, if necessary--shall be immediately accessible in the prescription area, and the telephone number shall coincide with the mandatory telephone number required to be printed on the label of a prescription.
(5) Sanitary facilities. Pharmacies shall be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. The sink shall measure at least 200 square inches exclusive of drainboard area. The sink shall be connected properly to supply hot and cold water. The sink shall be wholly located within the area designated as the prescription area. Adequate restroom facilities for employes of the pharmacy shall be provided reasonably close to, but outside of the prescription area, or with an entrance for the public located outside of the prescription area.
(6) Lighting and ventilation. The pharmacy shall be well lighted and ventilated.
(7) No television set. No television set may 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 shall be arranged in such a manner 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. No animals may 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. 97-1904. Filed for public inspection November 28, 1997, 9:00 a.m.]
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