PROPOSED RULEMAKING
[49 PA. CODE CH. 27]
General Revisions
[26 Pa.B. 1032] The State Board of Pharmacy (Board) proposes to amend §§ 27.1, 27.11, 27.12, 27.14--27.16, 27.18, 27.21 and 27.23--27.26. The amendments include both substantive changes and clarifications of dated or redundant language. The Board proposes these amendments under the authority of sections 3(f), 4(j) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-3(f), 390-4(j) and 390-6(k)(1) and (9)).
§ 27.1 (relating to definitions)
The Board proposes to delete the definitions of ''BNDD'' and ''caution legend drug or device'' and replaces them with the statutory definitions of ''DEA'' and ''nonproprietary drug.'' The Drug Enforcement Administration (DEA) has replaced the Bureau of Narcotics and Dangerous Drugs (BNDD). The term ''caution legend drug or device'' has also been replaced elsewhere in this proposed rulemaking. These proposed changes make the Board's regulations consistent with the statutory language and eliminate some confusion caused by the phrase ''caution legend drug or device.''
The Board proposes to add to its regulations the statutory definitions of ''medical practitioner,'' ''prescription'' and ''proprietary drug.'' See, 63 P. S. § 390-2(9), (8), and (7.2). The Board proposes to add new definitions of ''drug order,'' ''pharmacy intern,'' ''pharmacy technician'' and ''satellite pharmacy.'' The phrase ''drug order'' is the standard phrase in an institution for an order issued by a medical practitioner for a drug which will be administered to a patient. The definition of ''pharmacy intern'' derives from the internship requirement of section 3(b)--(f) of the act. The phrase ''pharmacy technician,'' a phrase which enjoys industrywide currency, is used for an unlicensed person who assists a pharmacist in the practice of pharmacy, as anticipated by sections 5(a)(7) and 8(2) of the act (63 P. S. §§ 390-5(a)(7) and 390-8(2)). The Board proposes to add the definition of ''satellite pharmacy'' to describe a pharmacy unit in an institution which is dependent on the main pharmacy. The Board also proposes to add the definitions of ''FDLE'' and ''NABPLEX,'' the two examinations required for licensure as a pharmacist.
The Board proposes to add to the regulatory definition of ''pharmacist manager'' the requirement of section 4(e) of the act that the permit to operate a pharmacy bear the name of the pharmacist in charge of the pharmacy, that is, the pharmacist manager.
§ 27.11. (relating to pharmacy permit and pharmacist manager)
The Board proposes to revise this section to clarify the language and to add several substantive changes. First, the statutory requirement of section 4(a)(4) of the act that a pharmacist shall be in charge of the pharmacy at all times that it is open, has been added at § 27.11(c).
Second, subsection (d) will require an application for change in ownership to be filed when there is a change in the controlling interest in a pharmacy, as well as a change in ownership. This addition will cover the situation of the small, closed corporation which holds a permit to operate a pharmacy and experiences a change in controlling interest. By requiring a new application, the Board will be able to keep track of the indentity of the individual who controls the corporation.
Third, the Board proposes to delete the provision which requires an applicant to attach photographs of the pharmacy to applications for a new permit or change in location. This provision will no longer be needed because Board inspectors will go to new pharmacies and new locations of existing pharmacies to inspect the premises.
Fourth, subsection (g) creates a means by which a pharmacy can gain 30 additional days to obtain a new pharmacist manager, if it has lost the services of a pharmacist manager and cannot replace the manager within the required 15 days. Under the current regulation, a pharmacy which cannot find a new manager within 15 days would be in violation of subsection (g). The proposed revision to subsection (g) will also make clear that both a pharmacist permit holder and a nonpharmacist permit holder have a duty to inform the Board of a change in pharmacist manager.
Fifth, subsection (h) proposes to restate the statutory requirement of section 4(c) of the act that a pharmacist may not manage more than one pharmacy at a time. However, the proposed amendment takes into account the situation of a permit holder who loses the services of a pharmacist manager and cannot immediately replace the person. The proposed amendment will allow the permit holder to request permission from the Board to allow the pharmacist manager of another pharmacy to serve as manager of the otherwise unmanaged pharmacy for up to 60 days beyond the expiration of the initial 15 days.
Sixth, subsection (i) specifies the conditions when an institution will be required to obtain a separate permit for a satellite pharmacy.
§ 27.12 (relating to practice of pharmacy and delegation of duties)
The Board has redrafted § 27.12. Subsection (a) restates the statutory principle that only a licensed person may engage in the practice of pharmacy. See 63 P. S. § 390-8(2).
Subsection (b) explains how a pharmacist may delegate aspects of the practice of pharmacy to a pharmacy intern or technician. Paragraphs (1) and (2) restate the current requirements that a pharmacist must review every prescription before it is filled and review the final product after it is filled. Section 8(2) of the act requires that interns or other authorized personnel work under the direct and immediate personal supervision of a pharmacist. Paragraph (3) defines direct, immediate and personal supervision. Paragraph (4) requires the pharmacist to take responsibility for the proper labeling of containers of nonproprietary drugs.
Subsection (c) outlines the role of the pharmacy intern. Subsection (d) outlines the role of the pharmacy technician. Under the proposed rulemaking, a pharmacy technician would be authorized to assist the pharmacist in compounding medications. Under the current subsection (b), only a pharmacist or intern may compound medications. Subsection (d)(4) requires the pharmacist manager to establish a written protocol for each pharmacy technician in the pharmacy. Finally, subsection (d)(5) requires that no more than two pharmacy technicians assist a pharmacist in the practice of pharmacy at any time. The Board, after holding public hearings and much discussion, concluded that a pharmacist could not supervise more than two technicians at a time and still assure that prescriptions or drug orders were being accurately and safely filled.
§ 27.14 (relating to supplies)
The proposed rulemaking clarifies this section. Subsection (b) has been redrafted for clarity and to bring the disposal of controlled substances into conformity with current Federal regulations at 21 CFR 1307.21 (relating to procedures for disposal of controlled substances).
The proposal revises subsection (c)(3) to require that the refrigerator for drugs be kept within the prescription area. The prohibition against the use of the refrigerator for anything other than drugs, vaccines, biologicals or medicaments has been dropped.
The proposal revises subsection (c)(15) to correct the titles of reference works from which a pharmacy must choose two and to add one new title, Physicians' Generix.
§ 27.15 (relating to sanitary standards)
The proposal revises this section for clarity and to eliminate redundant language. Subsection (d) removes the requirement that waste receptacles have covers and replaces it with the requirement that the waste removal system be adequate to maintain clean and sanitary conditions.
§ 27.16 (relating to construction and equipment requirements)
The heading of this section has been revised to include equipment requirements because the section deals with both construction and equipment.
Subsection (a)(1) has been revised for clarity. The revision also adds the requirement that when an applicant for a new pharmacy permit or change in location submits plans to the Board for review, the plans must include dimensions. Subsection (b)(2) eliminates the voluntary guidelines that related the size of a store to the size of the prescription area. The Board no longer believes that there is a significant relationship between the size of a store and the level of activity in the pharmacy.
Subsection (b)(3) has been rewritten and given a new heading: ''Self-contained pharmacy.'' The phrase is used to describe a pharmacy which is in or adjacent to a store but which can be securely sealed off from the store and, consequently, may keep different hours from the store. The remaining subparagraphs attempt to establish the security and integrity of the pharmacy when the pharmacy is closed but the larger or adjoining store is open.
Subsection (b)(4) is proposed to be amended to authorize a pharmacy to disperse controlled substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft of controlled substances, as an alternative to storing them in a locked cabinet. This proposed amendment would make the Board's regulations consistent with those of the DEA at 21 CFR 1301.75 (relating to physical security controls for practitioners). The presence of a locked cabinet has sometimes led burglars right to the stock of controlled subtances.
§ 27.18 (relating to standards of practice)
Section 27.18(a) is proposed to be amended to allow a pharmacist to reuse the original container for issuing a refill of a prescription, if the container is clean and capable of reuse. Numerous pharmacists have maintained that it is wasteful for a pharmacist to have to automatically discard the original container when a patient brings it in for a refill.
Subsection (b) deals with the requirements for prescriptions kept on file in the pharmacy. Subsection (b)(1) adds the requirements that a prescription on file show the address of the patient; the date the prescription was issued if it is for a controlled substance or if it was written with an ''as needed'' designation; and the cautions communicated to the ultimate consumer.
Under the current regulation a prescription on file has to show ''when required by statute, the address of the patient . . . and the BNDD number of the prescriber.'' This language caused some confusion among pharmacists. Some thought that all prescriptions must show the BNDD number. The proposed rulemaking clarifies this language by requiring an address for all prescriptions (supra) and the DEA number of the prescriber for prescriptions for controlled substances. Subsection (b)(3) revises but does not alter the substance of the current regulation. Subsection (b)(4) adds to the Board's regulations the requirement that original prescriptions be kept for 2 years. See, 63 P. S. § 390-4(a)(3). Subsection (b)(5) requires institutional pharmacies to keep records of Schedule II controlled substances which were dispensed by the pharmacy and received by the patient.
Subsection (c) identifies various circumstances under which a pharmacist may exercise professional judgment not to fill a prescription. In addition to the circumstances outlined in the current regulations the proposed rulemaking adds that a pharmacist may decline to fill a prescription if the pharmacist has reasonable cause to believe that it is false, that it will not be paid for, or that it will be diverted, abused or misused.
Subsection (d) is proposed to be revised at paragraph (4) to conform to a recent revision to section 11(f)(iii) of The Controlled Substance, Drug, Device and Cosmetic Act (Controlled Substance Act) (35 P. S. § 780-111(f)(iii)), which deleted the requirement that the Federal registration number (DEA number) of the prescriber appear on the label of the container of a prescription for a controlled substance. The prescriber's DEA number did not serve a useful purpose on a prescription container. The proposed revisions to paragraph (6) add clarity and allow a pharmacist to abbreviate the name of the manufacturer of a generic drug.
Subsection (d)(7) is proposed to be revised to add the requirement that when a person requests a copy of a prescription from a pharmacy, the person must identify his authority to request the copy and show identification. The Board adds this provision out of concern for the confidentiality of the patient.
Subsection (v) has been added to clarify labeling requirements for drug orders in institutions.
§ 27.21 (relating to application for examination and registration)
The Board proposes to revise this section pertaining to the application for examination to bring it up to date with current procedure. Under current procedures, an applicant obtains an application for licensure from the Board, files it together with supporting documentation with the Board, but also submits an examination scheduling form with the testing service which administers the examination.
§ 27.23 (relating to time and place for holding examination)
This section is proposed to be revised to recognize that the time and place for examination are determined by contract.
§ 27.24 (relating to examinations administered and passing grade)
This section is proposed to be revised to add the September administration of the licensure examinations and to eliminate dated language pertaining to the composition of the licensure examinations.
§ 27.25 (relating to licensure by reciprocity)
This section replaces the current § 27.25 (pertaining to failure to appear for examination). The current § 27.25 is unnecessary because this matter is covered by the examination contract and the examination fee is paid directly to the testing service. The proposed § 27.25 pertains to licensure by reciprocity. This section informs an applicant for licensure by reciprocity that he must have passed or pass the FDLE if the applicant gained licensure in another state after January 26, 1983. On that date, the FDLE became a requirement for licensure in this Commonwealth.
§ 27.26 (relating to pharmacy internship)
This section is proposed to be redrafted largely to clarify the language of the current section. Subsection (b) adds the requirement that the applicant for registration as an intern be of good moral character. This is implicit in section 3(a)(2) of the act which requires an applicant for licensure as a pharmacist to satisfy the Board that he is of good moral character. Subsection (d)(5) authorizes the Board to grant internship credit for hours that an individual served in a pharmacy before the individual registered as an intern upon a showing of good cause. The current regulation at subsection (e)(1) does not allow the Board to grant credit for hours worked before registration. This has caused a hardship in certain cases.
Subsection (d)(4) clarifies and replaces subsection (f)(1) of the current regulation in order to deal with internship hours that may be obtained through a pharmacy school program.
The Board proposes to revise subsection (h)(1) to authorize it to hear appeals and waive the requirement that a pharmacist may not have been convicted of an offense relating to the practice of pharmacy. The Board now believes that a conviction for even a relatively minor offense related to practice of pharmacy should not automatically bar a pharmacist from ever serving as a preceptor.
Fiscal Impact
This proposed rulemaking will not have a negative fiscal impact on either the Commonwealth or local government. An applicant for a new pharmacy permit or for a change in location may have slightly reduced costs because the applicant, under the change proposed to § 27.11(e), will no longer have to supply photographs of the pharmacy to the Board. The proposed requirement at § 27.11(d) that an application for change in ownership be filed when there is a change in controlling interest will increase costs for the pharmacy by the amount of the application. The Board believes that this increase is counterbalanced by the value to the Board of knowing the identity of the person who exercises a controling interest in a pharmacy. The proposed requirement at § 27.11(i) that a satellite pharmacy in an institution obtain a separate permit if the pharmacy had previously been in a separate institution or if its routine activity is dispensing drugs to outpatients will increase costs by the amount of the separate permit and any costs associated with that. The Board feels that these costs are counterbalanced by the fact that the satellite pharmacy under these circumstances constitutes a pharmacy which is distinct and separate from the primary pharmacy of the institution and cannot be adequately supervised by the pharmacist manager of the primary pharmacy of the institution. The proposed § 27.12(d) may lower costs to pharmacies by allowing a technician to assist a pharmacist in compounding drugs, including IV units, and performing tasks such as entering data in a computer. The proposed § 27.12(d)(3), which requires the pharmacist manager to create a written protocol for each technician employed in the pharmacy will increase costs. The Board believes that this cost will be counterbalanced by assuring that the technician has been trained and can safely perform each task that is assigned to the technician. The proposed § 27.18(a), which allows a pharmacist to reuse the patient's own vial for a refill of the same drug, will slightly reduce costs and waste.
Paperwork Requirements
The proposed rulemaking would not have an impact on the paperwork of the Commonwealth, local government or the general public. A pharmancy which makes use of technicians would have to prepare a written protocol for each technician. This will result in a slight increase in paperwork for the pharmacy.
Statutory Authority
Section 3(f) of the act authorizes the Board to promulgate regulations which prescribe the instructional content of the pharmacy internship. Section 4(j) of the act authorizes the Board to promulgate regulations governing standards of practice and operation of pharmacies, including regulations governing the standards for dispensing prescriptions to insure methods of operation and conduct which protect the public health, safety and welfare and prevent practices or operations which may tend to lower professional standards of conduct. Section 6(k)(1) of the act authorizes and requires the Board to regulate the practice of pharmacy. Section 6(k)(9) of the act authorizes and requires the Board to regulate the practice of pharmacy for the protection and promotion of the public health, safety and welfare.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Board submitted a copy of these proposed amendments on February 28, 1996, to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Committee on Professional Licensure and the Senate Committee on Professional Licensure and Consumer Protection. In addition to submitting the proposed amendments, the Board has provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the Board in compliance with Executive Order 1982-2, ''Improving Government Regulations.'' A copy of the material is available to the public upon request.
If IRRC has any objections to any portion of the proposed amendments, it will notify the Board within 30 days of the close of the public comment period. The notificiation shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review of objections prior to final publication of the regulations by the Board, the General Assembly and the Governor.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Richard Marshman, Executive Secretary, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
JOHN P. MARIANI, R.Ph.,
Chairperson(Editor's Note: For a proposal amending § 27.1, also proposed to be amended in this document, see 26 Pa.B. 1030 (March 9, 1996).)
Fiscal Note: 16A-542. No fiscal impact; (8) recommends adoption.
Annex
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL REVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * [BNDD--The Federal Bureau of Narcotics and Dangerous Drugs.]
* * * * * [Caution legend drug or device--Controlled substances and other drugs or devices which by statute or regulation may be dispensed to a patient by a pharmacist only upon the prescription of a medical practitioner.]
* * * * * DEA--The Federal Drug Enforcement Administration.
* * * * * Drug order--An oral or written order issued by a medical practitioner which is either written on or entered by computer into the medical record of a patient in an institution for the dispensing of a drug or device for administration to the patient. The term does not include an order for a drug for a patient in an institution which the patient will self-administer which will be considered a prescription.
FDLE--The Federal Drug Law Examination.
* * * * * Medical practitioner--A physician, dentist, veterinarian or other individual authorized and licensed by law to prescribe drugs.
NABPLEX--The National Association of Board of Pharmacy Licensure Examination.
Nonproprietary drug--A drug containing any quantity of any controlled substance or a drug which is required by an applicable Federal or State law to be dispensed only by prescription.
Pharmacist manager--The pharmacist named in the permit to operate a pharmacy who is in charge of a pharmacy [who is] and responsible for operations involving the practice of pharmacy under section 4 of the act (63 P. S. § 390-4).
Pharmacy--The [store or other] place licensed by the Board where the practice of pharmacy is conducted.
Pharmacy intern--A person registered by the Board as a pharmacy intern under section 3(e) of the act (63 P. S. § 390-3(e)) and § 27.26 (relating to pharmacy internship).
Pharmacy technician--An unlicensed person working in a pharmacy to assist a pharmacist in the practice of pharmacy in § 27.12 (relating to practice of pharmacy and delegation of duties). The term does not include a pharmacy intern or clerical or housekeeping personnel.
* * * * * Prescription--A written or oral order issued by a licensed medical practitioner in the course of his professional practice for a controlled substance, other drug or device or medication which is dispensed for use by a consumer.
* * * * * Proprietary drug--A nonprescription, nonnarcotic medicine or drug which may be sold without a prescription and which is prepackaged for use by the consumer and labeled in accordance with the requirements of Federal and State statutes and regulations.
Satellite pharmacy--A pharmacy in an institution which provides services for the inpatient population and is dependent upon the centrally located pharmacy for administrative control, staffing and drug procurement.
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