PROPOSED RULEMAKING
STATE BOARD
OF PHARMACY
[49 PA. CODE CH. 27]
Supplies and Equipment
[37 Pa.B. 1036]
[Saturday, March 3, 2007]The State Board of Pharmacy (Board) proposes to amend §§ 27.14 and 27.16 (relating to supplies; and construction and equipment requirements) to read as set forth in Annex A. The proposed rulemaking would delete references to specific supplies that a pharmacy must maintain and instead allow pharmacies to maintain equipment to enable them to prepare and dispense prescriptions properly within their scope of practice. The proposed rulemaking would also delete the reference to the specific measurement of a pharmacy sink.
Effective Date
The proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
Statutory Authority
The proposed rulemaking is 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 Amendments
Section 27.14(c) currently lists specific supplies and equipment that pharmacies must maintain (except pharmacies operating as central processing centers). Certain items on this list are outdated and not used in pharmacies anymore. Other items on the current list are not used in pharmacies that have specific practice areas, such as compounding pharmacies, nuclear pharmacies, veterinary pharmacies and so forth. This rulemaking proposes to amend § 27.14(c) by deleting the specific list of supplies and equipment and replacing it with language that permits a pharmacy to maintain supplies and equipment that are necessary to that pharmacy's area of practice. In addition, there are more advanced balances, scales and weights available than those specified in § 27.14(c)(1) and (2). There are also more advanced measuring tools than the graduates specified in § 27.14(c)(4). The remaining supplies in § 27.14(c)(5), (6), (7), (9) and (10) are outdated and not needed in most pharmacies. These supplies simply sit on the shelves unused. The Board is also deleting § 27.14(c)(9) because it is repetitive with the requirement that pharmacies keep records of prescriptions of controlled substances in accordance with the requirements of the Federal Drug Enforcement Administration in 21 CFR 1304.04(h) (relating to maintenance of records and inventories).
Section 27.16(b) currently requires that a pharmacy have a sink that measures at least 200 square inches exclusive of drainboard area. The Board proposes to delete the reference to specific measurements of the sink. The Board believes it is unnecessary to specify the size of the sink given the purposes for which it is used, such as hand washing and cleaning compounding equipment.
Description of Proposed Amendments
The proposed amendments to § 27.14 would delete the specific list of supplies and equipment in subsection (c)(1)--(10). The proposed amendment adds language that requires a refrigerator equipped with a thermometer or a temperature-monitoring device, which is used solely for the storage of drugs requiring refrigeration. This is the only specific equipment that the Board proposes to keep in the regulation but with amended language to make it clear that the refrigerator is not to be used for food storage.
The proposed amendment to § 27.16 deletes the specific measurements for the pharmacy sink.
Fiscal Impact
The proposed rulemaking would have no fiscal impact on the Commonwealth, its political subdivisions, the public or the regulated community.
Paperwork Requirements
The proposed rulemaking will not impose any additional paperwork requirements on the Commonwealth or the regulated community.
Sunset Date
The Board reviews the effectiveness of its regulations on an ongoing basis. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 21, 2007, the Board submitted a copy of this proposed rulemaking 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 Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review 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 17105-26409 within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
EDWARD J. BECHTEL, R.Ph.,
ChairpersonFiscal Note: 16A-5415. 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 § 27.14. Supplies.
* * * * * (c) [Except for a pharmacy operating as a central processing center, a] A pharmacy shall maintain at least the following equipment and supplies:
(1) [A Class A prescription balance or other scale with a no-load sensitivity of 6 milligrams or less.
(2) Both an apothecary set of weights from 1/2 grain to 1 ounce and a set of metric weights from 10 milligrams to 50 grams.
(3) A mechanical refrigerator having the appropriate temperature control for the storage of the drugs, vaccines, biologicals or medicaments which require specific temperatures for their stability. The refrigerator shall be kept within the prescription area.
(4) At least four graduates assorted to measure 1 ml to 500 ml.
(5) At least two mortars and pestals, glass or wedgewood.
(6) At least three spatulas of assorted sizes, metallic-rust resistant and rubber or nonmetallic composition.
(7) At least two funnels, one 120 ml and the other 480 ml.
(8) One glass or tile slab or specially treated paper for use in compounding ointments.
(9) A book to record sales and transfers of Schedule V controlled substances and poisons. This paragraph does not apply to an institutional pharmacy servicing only inpatients.
(10) An adequate supply of filter paper and powder papers and an adequate supply of empty capsules, prescription containers, prescription and poison and other applicable identification labels used in dispensing of prescription drugs and medication.]
A refrigerator, used solely for the storage of drugs requiring refrigeration, equipped with a thermometer or a temperature monitoring device.
[(11)] (2) * * *
[(12)] (3) * * *
[(13)] (4) * * *
(5) Additional equipment and supplies necessary to enable the pharmacy to properly prepare and dispense prescriptions consistent with its scope of practice.
[(14)] (6) * * *
* * * * * § 27.16. Construction and equipment requirements.
* * * * * (b) Building standards. The following apply to building standards:
* * * * * (5) Sanitary facilities. [Except for pharmacies operating as central processing centers, pharmacies] Pharmacies shall be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. [The sink must measure at least 200 square inches exclusive of drainboard area.] 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.
* * * * *
[Pa.B. Doc. No. 07-351. Filed for public inspection March 2, 2007, 9:00 a.m.]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
