RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Fees
[39 Pa.B. 5309]
[Saturday, September 12, 2009]The State Board of Pharmacy (Board) amends § 27.91 (relating to schedule of fees) to read as set forth in Annex A.
Description and Need for the Rulemaking
Section 8.2(a) of the Pharmacy Act (act) (63 P. S. § 390-8.2(a)) requires the Board to fix the fees, including renewal of licenses and permits, by regulation and if the revenue generated by fees, fines and civil penalties is not sufficient to match expenditures over a 2-year period, the Board is required to increase those fees by regulation. Section 8.2(b) of the act requires the Board to increase fees when revenue raised by fees, fines and civil penalties is not sufficient to meet expenditures.
In March, 2008, the Department of State's division of fiscal management projected that, without an increase in the biennial renewal fee, Board fiscal deficits will grow as follows:
Fiscal Year Beginning Balance Revenue Expenses Ending Balance 2007-08 $1,317,335 $500,000 $1,842,000 ($24,665) 2008-09 ($24,665) $3,000,000 $1,934,000 $1,041,335 2009-10 $1,041,335 $500,000 $2,031,000 ($489,665) 2010-11 ($489,665) $3,000,000 $2,133,000 $377,335 2011-12 $377,335 $500,000 $2,240,000 ($1,362,665) 2012-13 ($1,362,665) $3,000,000 $2,352,000 ($714,665) 2013-14 ($714,665) $500,000 $2,470,000 ($2,684,665) If, however, the renewal fee for pharmacies is increased from $100 to $125 beginning with the 2009-2011 renewal period and the renewal fee for pharmacists is increased from $150 to $190 beginning with the 2010-2012 renewal period, the fiscal management division projected that the Board would recover the deficit as follows:
Fiscal Year Beginning Balance Revenue Expenses Ending Balance 2007-08 $1,317,335 $500,000 $1,842,000 ($24,665) 2008-09 ($24,665) $3,000,000 $1,934,000 $1,041,335 2009-10 $1,041,335 $582,000 $2,031,000 ($407,665) 2010-11 ($726,926) $3,866,000 $2,133,000 $1,325,335 2011-12 $1,325,335 $582,000 $2,240,000 ($332,665) 2012-13 ($332,665) $3,866,000 $2,352,000 $1,181,335 2013-14 $1,181,335 $582,000 $2,470,000 ($706,655) Although the Board was presented with projections for other amounts of increase in the renewal fee, the Board concluded that increasing the biennial renewal fee approximately 25% as shown previously would be the least restrictive means of eliminating the projected deficits and restoring the Board's fiscal integrity as required under section 8.2 of the act.
As part of this process, the Board also considered the application fees that it charges. In general, the fee should be enough to cover the cost of providing that service. Based upon estimates of the amount of staff time necessary to process various applications and the cost of employing staff, together with necessary overhead, and rounding to the nearest $5, the fiscal management division recommended that the Board increase application fees as follows: pharmacy intern certificate from $30 to $35, pharmacist license from $40 to $45, new pharmacy permit from $100 to $125, reinspection of new pharmacy after failure of inspection from $90 to $115, pharmacy permit change without inspection from $30 to $45 and pharmacy permit change with inspection from $95 to $125. Because the Board should charge application fees sufficient to recover the cost of providing the services, the Board proposed to increase its application fees as recommended.
Summary of Comments and Responses to Proposed Rulemaking
The Board published a notice of proposed rulemaking at 38 Pa.B. 4784 (August 30, 2008) with a 30-day public comment period. The Board received no written comments from the public. The Board received comments from the House Professional Licensure Committee (HPLC) as part of its review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12). The Board did not receive any comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) or the Independent Regulatory Review Commission (IRRC).
The HPLC first noted that the Board did not propose to increase certain other application fees and requested the Board's rationale in increasing only the identified fees. While the fiscal management division looked at these fees as well, its analysis showed that the cost of providing those services was being recovered by the current fees. Therefore, the Board did not propose to increase those fees.
The HPLC also requested information pertaining to the major cost centers of the Board and any significant increases in their expenditures. According to the division of fiscal management, as of March, 2009, the Board's actual expenses for various cost centers have been as follows:
Category FY 2004-05 (actual) FY 2005-06 (actual) FY 2006-07 (actual) FY 2007-08 (projected) FY 2008-09 (budgeted) Bd. Admin. 294,282.75 240,641.66 412,292.42 420,468.05 441,000 Cmmsnr. Office 25,252.94 28,724.80 30,885.29 35,979.55 37,000 Dept. Services 77,269.68 79,087.31 73,247.57 74,475.09 95,000 Legal Office 338,508.09 315,962.44 315,713.63 288,239.01 333,000 Hearing Exp. 18,478.61 19,968.82 19,192.75 24,687.31 21,000 Leg./Reg. Anal. 4,346.87 7,360.86 6,830.66 8,098.10 11,000 Enf. & Invest. 643,654.07 571,909.98 647,126.85 765,942.00 723,000 PHMP 102,919.51 137,929.05 150,936.27 155,450.98 164,000 Bd. Members 28,172.42 33,145.54 27,503.47 34,318.34 64,000 Total Costs $1,532,884.94 $1,434,730.46 $1,683,728.91 $1,807,640.43 $1,889,000 As noted in the preamble for publication as proposed rulemaking, the increases in the Board's biennial expenses occurred primarily in administrative costs and costs for inspection, investigation and enforcement (Bureau of Enforcement and Investigation). Legal office costs remained about the same, despite the continued rise in the number of complaints from previous years. Administrative costs likely increased because the Board began receiving applications for the authority to administer injectable medications, immunizations and biologicals. Additionally, vacant pharmacy inspector positions were filled, which led to the increase in inspection, investigation and enforcement costs, both due to salaries and increased number of inspections.
In November, 2008, the fiscal management division provided updated projections, based upon the anticipated increase in fees and actual expenses and revenue, that would permit the Board to recover the deficit as follows:
Fiscal Year Beginning Balance Revenue Expenses Ending Balance 2006-07 ($81,593) $3,035,094 $1,683,729 $1,269,772 2007-08 $1,269,772 $658,963 $1,807,640 $121,095 2008-09 $121,095 $3,866,000 $1,889,000 $2,098,095 2009-10 $2,098,095 $582,000 $1,946,000 $734,095 2010-11 $734,095 $3,866,000 $2,004,000 $2,596,095 2011-12 $2,596,095 $582,000 $2,064,000 $1,114,095
The Board has not found a need to revise its rulemaking in response to the comments.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have no adverse fiscal impact on the Commonwealth or its political subdivisions and will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector. The final-form rulemaking will increase certain application fees charged by the Board and will increase the biennial renewal fee for pharmacists and pharmacies in this Commonwealth.
Effective Date
The final-form rulemaking will become effective upon publication in the Pennsylvania Bulletin. The increased renewal fee for pharmacies will first be charged for the biennial renewal period beginning September 1, 2009, and the increased renewal fee for pharmacists will first be charged for the biennial renewal period beginning October 1, 2010.
Statutory Authority
The final-form rulemaking is authorized under section 8.2 of the act.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 18, 2008, the Board submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 4784, 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 received 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 July 7, 2009, the HPLC approved the final-form rulemaking. On August 5, 2009, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5(g) of the Regulatory Review Act, the final-form rulemaking was deemed approved by IRRC effective August 5, 2009.
Additional Information
Persons who require additional information about the final-form rulemaking should submit inquiries to the Regulatory Unit Counsel, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7156, st-pharmacy@state.pa.us.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law and all comments were considered.
(3) The final-form rulemaking adopted by this order is necessary and appropriate for the administration of the act.
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 § 27.91 to read as set forth in Annex A.
(b) The Board shall submit this order and 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) The final-form rulemaking shall take effect upon publication in the Pennsylvania Bulletin.
MICHAEL A. PODGURSKI, R. Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 5096 (August 22, 2009).)
Fiscal Note: Fiscal Note 16A-5422 remains valid for the final adoption of the subject regulation.
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
FEES § 27.91. Schedule of fees.
An applicant for a license, certificate, permit or service shall pay the following fees at the time of application:
Application for pharmacy intern certificate $35
Application for pharmacist license $45
Certification of examination scores or internship
hours $25Verification of licensure $15
Assistant pharmacist biennial renewal $120
Registered pharmacist biennial renewal $190
Registered pharmacist late renewal penalty $25
New pharmacy permit application $125
Reinspection of new pharmacy after failure at
first inspection $115Pharmacy permit change without inspection $45
Pharmacy permit change when inspection
required $125Change in pharmacy ownership or Board of
Directors $30Verification of permit $15
Biennial renewal of pharmacy permit $125
Pharmacy permit late renewal penalty $25
Application for approval to administer injectables $30
Biennial renewal of approval to administer inject-
ables $30
[Pa.B. Doc. No. 09-1680. Filed for public inspection September 11, 2009, 9:00 a.m.]
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