NOTICES

INDEPENDENT REGULTORY REVIEW COMMISSION

Actions Taken by the Commission

[28 Pa.B. 3558]

   The Independent Regulatory Review Commission met publicly at 11 a.m., Thursday, July 9, 1998, and took the following actions:

Regulations Approved:

   State Board of Medicine #16A-498: Licensure, Certification, Examination and Registration Fees (amends 49 Pa. Code Chapter 16)

   State Board of Landscape Architects #16A-613: Fees (amends 49 Pa. Code Chapter 15)

Regulations Disapproved:

   State Board of Pharmacy #16A-542: General Revisions (amends 49 Pa. Code §§ 27.1, 27.11, 27.12, 27.14--27.16, 27.18, 27.21, 27.23, 27.24 and 27.26)

Regulations Deemed Approved under Section 5(g) of the Regulatory Review Act: Effective July 7, 1998

   Department of Transportation #18-340: Mechanical, Electrical and Electronic Speed-Timing Devices (amends 67 Pa. Code Chapter 105)

Regulations Deemed Approved under Section 5(g) of the Regulatory Review Act: Effective June 23, 1998

   Insurance Department #11-150: Anti-Arson Application (deletes 31 Pa. Code §§ 117.1--117.8)

   Insurance Department #11-159: Qualifications of Persons Signing Annual Financial Statements (deletes 31 Pa. Code §§ 135.1 and 135.2)

   Insurance Department #11-157: Uniform Bylaws for Mutual Fire Companies (deletes 31 Pa. Code Chapter 103)

Regulations Deemed Approved under Section 5(g) of the Regulatory Review Act: Effective June 26, 1998

   Insurance Department #11-152: Uniform Classification of Expenses (deletes 31 Pa. Code Chapters 1, 5, 7, and 9)

Commissioners Present: Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

State Board of Medicine--Licensure, Certification, Examination and Registration Fees; Regulation No. 16A-498

Order

   On February 4, 1998, the Independent Regulatory Review Commission (Commission) received this proposed regulation from the State Board of Medicine (Board). This rulemaking amends 49 Pa. Code Chapter 16. The authority for this regulation is section 6 of the Medical PracticeAct (63 P. S. § 422.6). The proposed regulation was published in the February 14, 1998 Pennsylvania Bulletin with a 30-day public comment period. The final-form regulation was submitted to the Commission on May 29, 1998.

   The regulation increases the renewal fees for six classes of licensees under the Board.

Licensee	Current Fee	New Fee
Medical	$80	$125
Graduate Trainee	$10	$15
Phys. Assistant, Midwife,    Acupuncturist	$25	$40
Drugless Therapist	$25	$35

   We have reviewed this regulation and find it to be in the public interest. The fees are necessary for the Board to meet its statutory obligation and to ensure that revenues are sufficient to meet expenditures.

Therefore, It Is Ordered That:

   1.  Regulation No. 16A-498 from the State Board of Medicine, as submitted to the Commission on May 29, 1998, is approved; and

   2.  The Commission will transmit a copy of this Order to the Legislative Reference Bureau.

Commissioners Present: Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

State Board of Landscape Architects--Fees; Regulation No. 16A-613

Order

   On June 16, 1998, the Independent Regulatory Review Commission (Commission) received this regulation from the State Board of Landscape Architects (Board). This rulemaking amends 49 Pa. Code Chapter 15. The authority for this regulation is Section 4(2) and 4(3) of the Landscape Architects Registration Law (law) (63 P. S. §§ 904(2) and 904(3)). Notice of proposed rulemaking was omitted for this regulation; it will become effective upon publication in the Pennsylvania Bulletin.

   The regulation deletes fees for the Landscape Architectural Registration Examination (LARE) for the 1995, 1996 and 1997 licensing examinations. Additionally, it establishes new testing fee amounts for the December 1998 and June and December of 1999 and 2000 licensing examinations as shown below.

	1998 LARE	1999 LARE		2000 LARE
Test Date	12/98	6/99	12/99	6/00
Section 1	Not available	$39	Not available	$40
Section 2	Not available	$69	Not available	$70
Section 3--6 each	$108	$108	$115	$115

   We have reviewed this regulation and find it to be in the public interest. The fees are being established to offset the contracted cost for the LARE licensing examination as required by the Law.

Therefore, It Is Ordered that:

   1.  Regulation No. 16A-613 from the State Board of Landscape Architects, as submitted to the Commission on June 16, 1998, is approved; and

   2.  The Commission will transmit a copy of this Order to the Legislative Reference Bureau.

Commissioners Present: John R. McGinley, Jr., Chairperson, Dissenting; Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

State Board of Pharmacy--General Revisions; Regulation No. 16A-542

Order

   On February 28, 1996, the Independent Regulatory Review Commission (Commission) received this proposed regulation from the State Board of Pharmacy (Board). This rulemaking amends 49 Pa. Code sections 27.1, 27.11, 27.12, 27.14--27.16, 27.18, 27.21, 27.23, 27.24 and 27.26. The proposed regulation also adds Section 27.25 Licensure by reciprocity and deletes Section 27.25 Failure to appear for examination. The authority for this regulation is 63 P. S. §§ 390-3(f), 4(j) and 6(k)(1) and (9). The proposed regulation was published in the March 9, 1996 Pennsylvania Bulletin with a 30-day public comment period. The final-form regulation was submitted to the Commission on April 6, 1998. The Commission disapproved the final-form regulation at the Public Meeting held May 7, 1998. The Board submitted this revised final-form regulation on June 15, 1998.

   The Board submitted this proposed regulation to generally revise, clarify and update existing regulations in 49 Pa. Code, which cover a broad range of pharmacy operations, including standards of practice, permits, equipment requirements, pharmacy technicians and pharmacy internships. The Board made many modifications to the regulation in response to the commentators' and Commission's Comments. However, the Commission had concerns with section 27.26(h) of the regulation regarding requirements for registration as a pharmacist preceptor and the definition of ''satellite pharmacy'' in section 27.1.

   In the revised final-form regulation, the Board inserted language that satisfactorily addresses our concerns with section 27.26(h) of the regulation regarding requirements for registration as a pharmacist preceptor. Pharmacists who have been convicted of a criminal offense related to the practice of pharmacy will not be allowed to be preceptors.

   The second concern cited in the Commission's disapproval Order was the definition of ''satellite pharmacy'' in section 27.1. This definition states: ''The term does not include . . . a pharmacy located off premises from the centrally located pharmacy of the institution regardless of whether the pharmacy is owned by the same person or entity which owns the institution.'' Health system providers commented that they are currently developing new efficiencies, and associated cost savings, which will not be realized if these regulations are approved. They believe the definition of satellite pharmacy would unnecessarily inhibit efficiencies they are developing in their delivery of care. The Commission also questioned the need to require a separate permit for ''off premises'' pharmacies.

   The Board has not modified the definition of satellite pharmacy in the revised final regulation. However, the Board has explained in the Preamble that it will work with the Department of Health (DOH) and other interested parties to develop overall standards and policies for health system-wide pharmaceutical care delivery. The Board stated the regulation is not meant to inhibit innovation in the delivery of pharmaceutical care. The Board will continue to make judgement calls in conjunction with DOH on the basis of individual institutional needs. The Board does not intend to require a pharmacy in a long-term care facility. However, the Board notes ''. . . where two acute care institutions are located miles apart, and where patient conditions may change dramatically, a single shared pharmacy would not likely protect the public health.''

   The Hospital and Healthcare Association of Pennsylvania (HAP) submitted a letter dated July 7, 1998, requesting that the Commission disapprove this revised final-form regulation. HAP finds the section relating to satellite pharmacies, as interpreted by the Board in the Preamble, to be confusing and unacceptable. HAP believes the plain language of the regulation does not support the Board's implication that it has the authority to determine when and where safe patient care demands an onsite pharmacy. HAP asserts that an institution is not dispensing drugs by simply accepting a ''locked box'' from another hospital's pharmacy for individual patient use and therefore the receiving facility is not engaging in the practice of pharmacy. HAP maintains that it is not the Board, but rather the DOH that has statutory authority to require a pharmacy in an institution to adequately safeguard patient care.

   We continue to have concerns with the regulation. We stated in our disapproval order that the language of the regulation needs to be clearer regarding when a pharmacy is considered to be ''off premises.'' The regulation simply does not provide a clear standard of what is and what is not a satellite pharmacy. Therefore, the definition of ''satellite pharmacy'' does not satisfy our criteria for clarity. Furthermore, we question the need for, economic impact and the cost-effectiveness of a definition that may require separate permits within a single healthsystem.

   We also question the statutory authority for the position the Board has taken in its Preamble. The Preamble implies that the Board has the authority to require a pharmacy in a separate facility. We disagree. This authority is vested in DOH and not the Board. (Healthcare Facilities Act (35 P. S. §§ 448.103--448.904b)) If a pharmacy is present, the Board has the authority to regulate its operation. We agree with HAP that the plain language of the regulation does not support the Board's implication that it has the authority to determine whether an on-site pharmacy is required at a facility.

   Second, the statute speaks to actions, which constitute the practice of pharmacy. In particular, the statute defines the term ''dispensing'' as ''the preparation of a prescription or non-prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the drug.'' Therefore, the practice of pharmacy occurs where drugs are dispensed, not at the point of administration. In a health systems environment, every aspect of operation is highly regulated by State and Federal authority. The distance between where a drug is dispensed and where it is administered is not subject to the jurisdiction of the Board.

   For these reasons we find that the regulation is still not in the public interest. The addition of language in section 27.26(h)(1) regarding pharmacist preceptors addresses the clarity and protection of the public concerns we raised. However, the Board did not make amendments to provide a clear standard of what is and what is not a satellite pharmacy. Therefore, the definition of ''satellite pharmacy'' violates our criteria of clarity, and raises serious questions of need, cost-effectiveness and economic impact.

Therefore, It Is Ordered That:

   1.  Regulation No. 16A-542 from the State Board of Pharmacy, as resubmitted to the Commission on June 15, 1998, is disapproved; and

   2.  The Commission will notify the State Board of Pharmacy of its action disapproving Regulation No. 16A-542;

   3.  The Commission will transmit this Order and the Report of the State Board of Pharmacy to the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee;

   4.  The Commission will transmit a copy of this Order to the Legislative Reference Bureau; and

   5.  This Order constitutes a bar to final publication of Regulation No. 16A under section 7(c) of the Regulatory Review Act.

Commissioners Present: Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

Department of Transportation--Mechanical, Electrical and Electronic Speed-Timing Devices; Regulation No. 18-340

Order

   On March 31, 1997, the Independent Regulatory Review Commission (Commission) received the proposed version of this regulation from the Department of Transportation (Department). This rulemaking would amend 67 Pa. Code Chapter 105. The authority for this regulation is contained in sections 3368 and 6103 of the Vehicle Code (75 Pa. C.S. §§ 3368 and 6103). The proposed version of this regulation was published in the April 12, 1997 edition of the Pennsylvania Bulletin with a 30-day public comment period. The final-form version of this regulation was submitted to the Commission on June 16, 1998.

   The final-form version of this regulation contains no changes from the initially proposed version. We did not file any comments on the proposed version of this regulation. Furthermore, we did not receive any negative recommendations on the final-form version of this regulation from the House Transportation Committee or the Senate Transportation Committee.

Therefore:

   The Commission will notify the Legislative Reference Bureau that Regulation No. 18-340 from the Department of Transportation, as submitted to the Commission on June 16, 1998, was deemed approved under section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) on July 7, 1998.

Commissioners Present: Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

Insurance Department--Anti-Arson Application; Regulation No. 11-150

Order

   On March 31, 1997, the Independent Regulatory Review Commission (Commission) received the proposed version of this regulation from the Insurance Department (Department). This rulemaking would delete 31 Pa. Code §§ 117.1 through 117.8. The authority for this regulation is 40 P. S. § 1615. The proposed version of this regulation was published in the April 12, 1997 Pennsylvania Bulletin with a 30-day public comment period. The final-form version of this regulation was submitted to the Commission on June 1, 1998.

   The final-form version of this regulation contains no changes from the initially proposed version. We did not file any comments on the proposed version of this regulation. Furthermore, we did not receive any negative recommendations on the final-form version of this regulation from the House Insurance Committee or the Senate Banking and Insurance Committee.

Therefore:

   The Commission will notify the Legislative Reference Bureau that Regulation No. 11-150 from the Insurance Department, as submitted to the Commission on June 1, 1998, was deemed approved under sction 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) on June 23, 1998.

Commissioners Present : Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

Insurance Department--Uniform Classification of Expenses; Regulation No. 11-152

Order

   On June 3, 1997, the Independent Regulatory Review Commission (Commission) received the proposed version of this regulation from the Insurance Department (Department). This rulemaking would delete 31 Pa. Code Chapters 1, 5, 7 and 9. The authority for this regulation is 40 P. S. § 443. The proposed version of this regulation was published in the July 5, 1997 Pennsylvania Bulletin with a 30-day public comment period. The final-form version of this regulation was submitted to the Commission on June 5, 1998.

   The final-form version of this regulation contains no changes from the initially proposed version. We did not file any comments on the proposed version of this regulation. Furthermore, we did not receive any negative recommendations on the final-form version of this regulation from the House Insurance Committee or the Senate Banking and Insurance Committee.

Therefore:

   The Commission will notify the Legislative Reference Bureau that Regulation No. 11-152 from the Insurance Department, as submitted to the Commission on June 5, 1998, was deemed approved under section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) on June 26, 1998.

Commissioners Present: Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

Insurance Department--Qualifications of Persons Signing Annual Financial Statements; Regulation No. 11-159

Order

   On June 3, 1997, the Independent Regulatory Review Commission (Commission) received this proposed regulation from the Insurance Department (Insurance). This rulemaking deletes 31 Pa. Code §§ 135.1 and 135.2. The authority for these changes is sections 206, 506, 1501, and 1502 of The Administrative Code of 1929 (71 P. S. §§ 66, 186, 411 and 412); section 301(g) of the Insurance Department Act of 1921 (section 301(g)) (40 P. S. § 71(g)); and section 320(a)(2) of the Insurance Company Law (section 320(a)(2)) (40 P. S. § 443). The proposed regulation was published in the Pennsylvania Bulletin on June 14, 1997, with a 30-day public comment period. The final-form regulation was submitted to the Commission on June 1, 1998.

   This rulemaking will delete existing provisions that are outdated and no longer used by Insurance. Insurance applies, instead, other requirements. Section 301(g), section 320(a)(2) and provisions of 31 Pa. Code § 84b.5(b) establish qualifications for actuaries regarding financial statements filed by life insurers, property and casualty insurers, and fraternal benefit societies.

   The final-form regulation contains no changes from the proposed version. The Commission did not file any comments on the proposed regulation. Furthermore, we did not receive any negative recommendations on the final-form regulation from the House Insurance Committee or the Senate Banking and Insurance Committee.

Therefore:

   The Commission will notify the Legislative Reference Bureau that Regulation No. 11-159 from the Insurance Department, as submitted to the Commission on June 1, 1998, was deemed approved under sections 5(g) of the Regulatory Review Act on June 23, 1998.

Commissioners Present: Alvin C. Bush, Vice Chairperson; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner

Public Meeting held
July 9, 1998

Insurance Department--Uniform Bylaws for Mutual Fire Companies; Regulation No. 11-157

Order

   On June 18, 1997, the Independent Regulatory Review Commission (Commission) received this proposed regulation from the Insurance Department. This rulemaking deletes 31 Pa. Code Chapter 103. The authority for this regulation is sections 206, 506, 1501 and 1502 of The Administrative Code of 1929 (71 P. S. §§ 66, 186, 411 and 412). The proposed regulation was published in the June 28, 1997 Pennsylvania Bulletin with a 30-day public comment period. The final-form regulation was submitted to the Commission on June 1, 1998.

   This regulation repeals Chapter 103. This chapter was originally adopted in 1936 and is now obsolete and out of date. The chapter recommends but does not require the standardization of bylaws for one small subset of insurers--domestic mutual fire insurance companies. In 1988, the Commonwealth adopted a comprehensive corporations code in the Associations Code (15 Pa.C.S.A. § 101 et seq.) and insurers may adopt bylaws consistent with this law. Chapter 103 does not contain all the provisions that a domestic mutual fire insurance company may need in its bylaws to be consistent with the current code. Hence, the existing regulation is incomplete as well as outdated.

   The final-form regulation contains no changes from the proposed regulation. We did not file any comments on the proposed regulation. Furthermore, we did not receive any negative recommendations on the final-form regulation from the House Insurance Committee or Senate Banking and Insurance Committee.

Therefore:

   The Commission will notify the Legislative Reference Bureau that Regulation No. 11-157 from the Insurance Department, as submitted to the Commission on June 1, 1998, was deemed approved under section 5(g) of the Regulatory Review Act on June 23, 1998.

JOHN R. MCGINLEY, Jr.,   
Chairperson

[Pa.B. Doc. No. 98-1201. Filed for public inspection July 24, 1998, 9:00 a.m.]

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