PROPOSED RULEMAKING
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Sales of Hypodermic Needles and Syringes
[37 Pa.B. 4652]
[Saturday, August 25, 2007]The State Board of Pharmacy (Board) proposes to amend § 27.18 (relating to standards of practice) to read as set forth in Annex A. The proposed rulemaking would alter the current requirements regarding the sale of hypodermic needles and syringes in pharmacies. The proposed rulemaking would permit a pharmacist to sell up to 30 hypodermic needles and syringes to persons 18 years of age or older without a prescription.
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 Proposed Rulemaking
In February 2005, Pennsylvanians for the Deregulation of Syringe Sales petitioned the Board under 1 Pa. Code § 35.18 (relating to petitions for issuance, amendment, waiver or deletion of regulations) to amend § 27.18(s)(2) to eliminate the prescription requirement for the sale of hypodermic needles and syringes. The Board subsequently heard testimony in support of the proposed amendment at its August 16-17, 2005, meeting from Dr. Scott Burris of Pennsylvania Coalition to Save Lives Now; Renee Cox of Prevention Point Pittsburgh; and Janice Kopelman, Director of the Department of Health's Bureau of Communicable Diseases.
Under the current regulation, which has not been amended for a number of years, the sale of hypodermic needles and syringes in pharmacies in this Commonwealth may only occur under the presentation of a prescription. More recently, studies have shown that increased access to clean needles and syringes has been proven to reduce the transmission of hepatitis C and HIV. The evidence also suggests that drug use will not increase if the prescription requirement is removed. See Douglas A. McVay, (ed.). Drug War Facts 2006, (citing National Commission on AIDS, The Twin Epidemics of Substance Abuse and HIV (Washington, DC: National Commission on AIDS, 1991); General Accounting Office, Needle Exchange Programs: Research Suggests Promise as an AIDS Prevention Strategy (Washington, DC: US Government Printing Office, 1993); Lurie, P. & Reingold, A.L., et al., The Public Health Impact of Needle Exchange Programs in the United States and Abroad (San Francisco, CA: University of California, 1993); Satcher, David, MD, (Note to Jo Ivey Bouffard), The Clinton Administration's Internal Reviews of Research on Needle Exchange Programs (Atlanta, GA: Centers for Disease Control, December 10, 1993); National Research Council and Institute of Medicine, Normand, J., Vlahov, D. & Moses, L. (eds.), Preventing HIV Transmission: The Role of Sterile Needles and Bleach (Washington, DC: National Academy Press, 1995); Office of Technology Assessment of the U. S. Congress, The Effectiveness of AIDS Prevention Efforts (Springfield, VA: National Technology Information Service, 1995); National Institutes of Health Consensus Panel, Interventions to Prevent HIV Risk Behaviors (Kensington, MD: National Institutes of Health Consensus Program Information Center, February 1997).
In 2000, the National Association of Boards of Pharmacy encouraged boards of pharmacy to revise laws and regulations to permit the sale and distribution of sterile needles and syringes. The Commonwealth is one of only four states that still prohibit the sale of hypodermic needles and syringes in pharmacies without a prescription. Through 2004, this Commonwealth was the seventh leading state reporting the highest number of cumulative AIDS cases among residents, with 30,174 cases. See Centers for Disease Control and Prevention, HIV/AIDS Surveillance Report, 2004, Vol. 16. Atlanta: United States Department of Health and Human Services, Centers for Disease Control and Prevention; 2005: page 27. (Available at www.cdc.gov/hiv/stats/hasrlink.htm.)
The Board recognizes that there is a compelling public health interest in reducing the spread of hepatitis C and HIV. Increased access to clean needles and syringes is essential to this interest. Studies have shown that removing the requirement that hypodermic needles and syringes only be sold with a prescription in pharmacies in this Commonwealth would not lead to increased drug use. To this end, the Board proposes amending the prescription requirement by permitting pharmacists to sell up to 30 hypodermic needles and syringes to persons 18 years of age or older without a prescription. Persons who use hypodermic needles and syringes for injecting medications may still obtain more than 30 by presenting a prescription. It is anticipated that many patients will continue to present a prescription to obtain prescription benefits in paying for hypodermic needles and syringes.
Description of Proposed Amendments
The proposed rulemaking would amend § 27.18(s)(2) to eliminate the requirement that a prescription be presented in all cases for a pharmacist to sell hypodermic needles and syringes to persons 18 years of age and older. Further, the proposed rulemaking would require that these needles and syringes be kept in the prescription area of the pharmacy. Section 27.1 (relating to definitions) defines ''prescription area'' as the area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy. The term does not include waiting counters or display space attached to the waiting counter. Hypodermic needles and syringes would have to be stored behind the counter and accessible only by pharmacists and pharmacy personnel authorized to be behind the counter while the pharmacy is open. Anyone under 18 years of age would still need to present a prescription to purchase hypodermic needles and syringes in a pharmacy.
The proposed amendment would also delete § 27.18(s)(1), which requires pharmacists to report to the Board the sale of accessories found in illegal traffic when sold in unusually large quantities; as well as the language that deems it unprofessional conduct to sell, give away or otherwise dispose of accessories, chemicals or proprietary products when the pharmacist knows or has reason to know of their intended use for illegal purposes. The Board proposes to remove this language because it has not served as the basis for disciplinary action in the recent history of the Board, nor has the Board received a report as currently required by this section. The reporting requirement is unenforceable and counterintuitive to the goal of the proposed rulemaking. The language that deems it unprofessional conduct to sell, give away or otherwise dispose of accessories, chemicals or proprietary products when the pharmacist knows or has reason to know of their intended use for illegal purposes is also counterintuitive to the goal of the proposed rulemaking. Furthermore, it is duplicative in that § 27.18(u) provides that a violation of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-143) or the rules and regulations promulgated thereunder constitutes a violation of the Board's regulations and the act.
The Department of Health recommended that the Board also require pharmacies to distribute information on safe needle disposal. The Board declined to include this in the proposed rulemaking, but will work with the Department of Health to alert pharmacies of available literature and safe needle disposal practices.
Fiscal Impact
The proposed rulemaking will have no fiscal impact on the Board or the regulated community.
Paperwork Requirements
The proposed rulemaking will impose no paperwork requirements on the Board or the regulated community.
Sunset Date
The Board monitors 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 August 15, 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 House Professional Licensure Committee and the Senate Consumer Protection and 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 17105-2649, within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
EDWARD J. BECHTEL, R.Ph.,
ChairpersonFiscal Note: 16A-5418. 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 § 27.18. Standards of practice.
* * * * * (s) [The following provisions are applicable to paraphernalia and accessories:
(1) Sale of accessories, such as empty capsules, quinine, sugar of milk or a similar product found in illegal traffic when sold in unusually large quantities shall be immediately reported to the Board. A pharmacist who sells, gives away or otherwise dis-poses of accessories, chemicals or proprietary prod-ucts when the pharmacist knows or has reason to know of their intended use for illegal purposes shall be guilty of unprofessional conduct and in violation of this chapter.
(2) Sales of needles and syringes shall be made by the pharmacist only to persons showing a prescription issued by a licensed practitioner. The prescription shall be in force for a maximum of 1 year from date of its issuance. This subsection shall take effect 3 months after the other provisions of this chapter take effect in order to give the public ample notice.]
Sales of hypodermic needles and syringes shall be made by a pharmacist or under the direct supervision of a pharmacist in accordance with the following:
(1) Up to 30 hypodermic needles and syringes may be sold to persons 18 years of age or older without a prescription.
(2) Sales of over 30 hypodermic needles and syringes shall be made only to persons presenting a prescription issued by a licensed practitioner.
(3) Sales of hypodermic needles and syringes may not be made to persons under 18 years of age without a prescription.
(4) Hypodermic needles and syringes shall be kept in the prescription area of the pharmacy, as defined in § 27.1 (relating to definitions), and be accessible only by pharmacists and pharmacy personnel authorized to be in the prescription area of the pharmacy while the pharmacy is open.
* * * * *
[Pa.B. Doc. No. 07-1552. Filed for public inspection August 24, 2007, 9:00 a.m.]
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