RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Supplies and Equipment
[38 Pa.B. 4895]
[Saturday, September 6, 2008]
The State Board of Pharmacy (Board) amends §§ 27.14 and 27.16 (relating to supplies; and construction and equipment requirements) to read as set forth in Annex A. The final-form rulemaking deletes references to specific supplies that a pharmacy must maintain and instead allows pharmacies to maintain equipment to enable them to prepare and dispense prescriptions properly within their scope of practice. The final-form rulemaking also deletes the reference to the specific measurement of a pharmacy sink.
Notice of proposed rulemaking was published at 37 Pa.B. 1036 (March 3, 2007). Publication was followed by a 30-day public comment period. The Board received no public comments, however the Pennsylvania Pharmacists Association has indicated its support of these amendments in correspondence with the Independent Regulatory Review Commission (IRRC). The House Professional Licensure Committee (HPLC) submitted two comments to the proposed rulemaking on April 18, 2007. The Senate Consumer Protection and Professional Licensure Committee made no comments. IRRC submitted no comments to the proposed rulemaking.
Summary of Comments and Responses to Proposed Rulemaking
The HPLC noted that the proposed rulemaking deleted the requirement that the refrigerator be kept within the prescription area and asked if it was the Board's intent to remove that requirement. The Board did not intend to remove that requirement, but notes that the definition of prescription area includes the area of the pharmacy used for legend drug storage. As the refrigerator is to be used solely for drugs requiring refrigeration it would necessarily have to be kept in the prescription area. However, the Board understands that one could interpret the change in the regulation to mean that the refrigerator no longer has to be located in the prescription area. To avoid any confusion, the Board has amended § 27.14(c)(1) (relating to supplies) to require the refrigerator to be kept in the prescription area.
The HPLC next asked what criteria the Board's inspectors will use for performing inspections. In many states where the regulations are similar to these amendments, inspectors still use a checklist to guide them during a pharmacy inspection. The Bureau of Enforcement and Investigation anticipates that it will develop inspection guidelines, with input from the Board, based on different pharmacy practice settings. Inspection for supplies is only a small part of what the inspectors look for during an inspection. Inspectors also look at items such as filing of prescriptions, labels, cleanliness of the pharmacy, outdated drugs, posting of the pharmacy permit and technician protocols.
In the final-form rulemaking, the Board also reinserted the language that was added by the Board's ''Technology and Automation'' rulemaking in 2006. See 36 Pa.B. 2518 (May 27, 2006). This language was inadvertently omitted from the proposed rulemaking and the text was deleted from the proposed rulemaking by the Legislative Reference Bureau. The Board did not intend for this language to be deleted and has amended the final-form rulemaking package to reinsert the language as intended.
The amendments are authorized under sections 4(j) and 6(k)(1) of the Pharmacy Act (act) (63 P. S. §§ 390-(4)(j) and 390-6(k)(1)).
Fiscal Impact and Paperwork Requirements
The amendments would have not a fiscal impact on the Commonwealth, its political subdivisions, the public or the regulated community. The amendments will require the Board to revise the inspection forms. There will be no additional paperwork requirements imposed on the regulated community.
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 the notice of proposed rulemaking, published at 37 Pa.B. 1036, 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 June 25, 2008, the final-form rulemaking was approved by the HPLC. On July 23, 2008, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on July 24, 2008, and approved the final-form rulemaking.
Individuals who need information about the regulations may contact Melanie Zimmerman, R.Ph., Executive Secretary, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649.
The Board finds that:
(1) Public notice of intention to adopt the regulations in 49 Pa. Code Chapter 27, was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated under those sections in 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking of the Board is necessary and appropriate for the administration of the act.
(4) The amendments to this final-form rulemaking do not enlarge the original purpose of the proposed amendments published at 37 Pa.B. 1036.
The Board therefore orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending §§ 27.14 and 27.16 to read as set forth in Annex A.
(b) The Board shall submit this order and a copy of 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) This order shall take effect upon publication in the Pennsylvania Bulletin.
MICHAEL A. PODGURSKI, R.Ph.,
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 38 Pa.B. 4449 (August 9, 2008).)
Fiscal Note: Fiscal Note 16A-5415 remains valid for the final adoption of the subject regulations.
TITLE 49. PROFESSIONAL
AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL
AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD
§ 27.14. Supplies.
(a) A pharmacy shall maintain a supply of drugs and devices adequate to meet the needs of the health professions and the patients it is intended to serve. The applicant for a pharmacy permit shall show proof by affidavit that the applicant has ordered or possesses and shall continue to maintain an inventory of nonproprietary drugs, devices and equipment appropriate to the practice of that pharmacy. The inventory must include at least $5,000 worth of nonproprietary drugs and devices, at cost, from a licensed wholesaler or manufacturer. The inventory may not go below this figure at any time. A central processing center is not required to maintain $5,000 worth of nonproprietary drugs and devices under § 27.203(b) (relating to centralized prescription processing).
(b) Drugs which must be removed from active stock shall be removed in accordance with the following provisions:
(1) The pharmacist manager is responsible for removing from the active stock of the pharmacy and disposing of the following:
(i) A drug whose expiration date has passed.
(ii) A drug which does not meet legal standards of strength and purity.
(iii) A drug which varies from the strength and purity indicated on the label of the commercial container.
(iv) A drug which has been improperly stored.
(v) A drug which has deteriorated.
(vi) A drug which is unfit, misbranded or adulterated under Federal or State statutes.
(2) Drugs which have been removed from active stock in accordance with this subsection may not be sold or given away. The drugs shall be returned to the wholesaler or manufacturer for disposal or disposed of by the pharmacy according to Federal or State statutes or regulations.
(3) A pharmacy desiring to or required to dispose of a controlled substance shall contact the nearest DEA office for authority and instructions to dispose of the substance.
(4) The pharmacist manager shall be responsible for keeping proper records of controlled substances which have been disposed of. These records must include the name of the substance, the number of units or the volume of the substance or the number of commercial containers and the date and manner of disposal.
(c) Except for a pharmacy operating as a central processing center, a pharmacy shall maintain at least the following equipment and supplies:
(1) A refrigerator, used solely for the storage of drugs requiring refrigeration, equipped with a thermometer or a temperature monitoring device. The refrigerator shall be kept in the prescription area.
(2) Prescription files for keeping prescriptions of nonproprietary drugs in accordance with the act and, for controlled substance prescriptions, State and Federal laws and regulations. The original prescription or image of the original prescription shall be retained for 2 years from the date of the most recent filling. A pharmacy may make use of a computerized recordkeeping system for keeping track of telephone prescriptions, refills, counseling, and the like in accordance with § 27.202 (relating to computerized recordkeeping systems).
(3) Current copies of the act and this chapter.
(4) Federal and Commonwealth statutes and regulations pertaining to the practice of pharmacy.
(5) Additional equipment and supplies necessary to enable the pharmacy to properly prepare and dispense prescriptions consistent with its scope of practice.
(6) An adequate reference library which meets the following standards:
(i) Enables a pharmacy to prepare and dispense prescriptions properly, consistent with its scope of practice.
(ii) Includes reference sources appropriate to the type of pharmacy practice at that particular location. A pharmacy shall include in the pharmacy's library current material regarding the technical, clinical and professional aspects of practice with emphasis in the area in which the pharmacy specializes.
(iii) Enables the pharmacist to compound medications in a safe and effective manner consistent with accepted standards of pharmacy practice.
(iv) Lists the possible drug interactions and possible adverse effects of medications dispensed by the pharmacy.
(v) Lists the therapeutic equivalents for medications.
(vi) Lists the therapeutic usage and dosages of medications dispensed by the pharmacy.
(vii) Provides guidelines for the counseling of patients.
(viii) A pharmacy that specializes in nuclear or parenteral prescriptions may limit the library it maintains under subparagraph (ii) relating to the pharmacy's own specialization.
(ix) Maintains the latest editions including current supplements of each of its reference sources.
(d) A pharmacy operating as a central processing center shall maintain equipment, supplies and access to a reference library recognized by the pharmacy community in this Commonwealth as meeting minimum standards of practice as a central processing center.
§ 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 and on duty.
(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. 08-1623. Filed for public inspection September 5, 2008, 9:00 a.m.]
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