RULES AND REGULATIONS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Sales of Hypodermic Needles and Syringes
[39 Pa.B. 5312]
[Saturday, September 12, 2009]
The State Board of Pharmacy (Board) adopts amendments to § 27.18 (relating to standards of practice) to read as set forth in Annex A. The rulemaking alters the requirements regarding the sale of hypodermic needles and syringes in pharmacies.
Notice of proposed rulemaking was published at 37 Pa.B. 4652 (August 25, 2007). Publication was followed by a 30-day public comment period. The Board received comments from the National Association of Social Workers, the Pennsylvanians for the Deregulation of Syringe Sales, the Pennsylvania Medical Society (PMS), Allegheny General Hospital, Pittsburgh AIDS Task Force (PATF), Prevention Point Pittsburgh, Southwestern Pennsylvania AIDS Planning Coalition (SWPAPC), Montefiore Medical Center, the AIDS Law Project of Pennsylvania, Representative Babette Josephs, Valley Forge Medical Center & Hospital, the University of Pittsburgh Program for Health Care to Underserved Populations, the Student Global AIDS Project of the University of Pittsburgh, the American Civil Liberties Union of Pennsylvania, Reading Risk Reduction, the American Liver Foundation, the Pennsylvania Pharmacists Association and many individual commentators. The House Professional Licensure Committee (HPLC) submitted four comments to the proposed rulemaking on October 3, 2007. The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) made no comments. The Independent Regulatory Review Commission (IRRC) submitted two comments to the proposed rulemaking on October 24, 2007.
Summary of Comments and Responses to Proposed Rulemaking
IRRC and several other commentators questioned the need for the provision in the proposed amendment that prohibited the sale of needles and syringes to persons under the age of 18 without a prescription. Upon review of the comments, the Board has reconsidered this provision and removed it in the final-form rulemaking. While some commentators wrote to support the age limitation, the Board ultimately decided that the limitation served no compelling public health interest.
Limitation on Number of Syringes and Needles Dispensed
PATF, Prevention Point Pittsburgh, SWPAPC and other individual commentators wrote to encourage the Board to consider removing the restriction on the number of syringes that can be purchased at one time. HPLC questioned the provision in the proposed rulemaking that placed a limit of 30 on the number of syringes that could be dispensed without a prescription. HPLC noted that other states have limits of ten syringes and needles. The Board initially chose 30, as it believed that ten was too few to dispense at one time. However upon reading the comments, the Board decided to remove the limitation altogether bringing the regulation in line with the majority of states that have no limit on the number of syringes dispensed without a prescription. HPLC also asked for information about whether the 30-syringe limitation would be for a specified time period. Having chosen to remove this limitation, the question was moot.
HPLC also questioned what type of recordkeeping would be used to track the number of syringes dispensed to individuals. The Board is not imposing a recordkeeping requirement. The Board does not believe that maintaining a record and requiring individuals to provide a name or other identifying information would advance the public health and safety. In fact, such a requirement could act to deter individuals from purchasing needles and syringes in a pharmacy.
HPLC commented that the proposed rulemaking required direct supervision by a pharmacist while the Board's regulation in § 27.12(b)(2) (relating to practice of pharmacy and delegation of duties) requires direct, immediate and personal supervision. HPLC requested clarification of the two different standards. The Board meant to have the same standard as is used for all auxiliary personnel and has changed the language in the final-form rulemaking package to require direct, immediate and personal supervision by a pharmacist.
PMS suggested a study to determine whether insurers should be mandated to preserve reimbursement for diabetics and people with other medical conditions requiring injected medications. IRRC urged the Board to work with necessary authorities to ensure that this rulemaking does not have a negative fiscal impact on people who obtain needles and syringes with a prescription and the assistance of medical insurance. The Board does not have the resources or funds to conduct such a study; moreover, the Board does not regulate or mandate insurance coverage for any prescription items. However, the Board notes that insulin is not a prescription item but is still generally covered by medical insurance.
PMS expressed concern regarding the proposed amendment and stated that it could not support the amendment until several qualifications were studied. The first qualification that PMS noted was that the proposed amendment not act to increase the number of IV drug users. As stated in the preamble to the proposal, several studies clearly indicate no increase in the number of IV drug users following the adoption of similar regulations in other states. No further studies have been published since the proposed amendment. Therefore the Board is confident that the change in this amendment will not act to do so in this Commonwealth. PMS next noted that syringe exchange programs should be bolstered to encourage intravenous drug users to become drug free. The Board supports the premise of recovery and rehabilitation for anyone addicted to any kind of drug, however, the Board notes that it does not have purview over syringe exchange programs. PMS next noted that pharmacies should be required to provide materials that educate illicit drug users about the associated risks and encourage drug use withdrawal, and education resources are made available throughout the State. The Board considered this idea when drafting the proposed amendment but chose not to put in a regulatory requirement. Instead, the Board is working with the Department of Health to make available to pharmacies pamphlets on topics such as addiction, HIV/AIDS and cocaine. Information about how to obtain these materials will be available on the Board's web site upon final-form rulemaking. The next qualification PMS noted was that syringes should be kept in the prescription area of the pharmacy. The proposed rulemaking required that needles and syringes be kept in the prescription area and that requirement has not changed in the final-form rulemaking.
PMS next noted that drug paraphernalia laws should be reviewed and changed to accommodate the proposal. The Board believes that no change in the laws pertaining to drug paraphernalia is necessary to implement the regulation. Needles and syringes are not, per se, drug paraphernalia. Drug paraphernalia is defined in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144) (Drug Act), in pertinent part, as, ''all equipment, products and materials of any kind which are used, intended for use or designed for use in . . . injection . . . or otherwise introducing into the human body a controlled substance in violation of this act. It includes, but is not limited to . . . (11) Hypodermic syringes, needles and other objects used, intended for use, or designed for use in parenterally injected controlled substances into the human body.'' Determination of whether an object is drug paraphernalia depends on the intent of the person distributing the object. To be classified as drug paraphernalia, the distributor must have the specific intent that the item be used with controlled substances. Commonwealth v. Lacey, 344 Pa. Super. 576, 582, 496 A.2d 1256 (1985). ''The [Drug] Act includes a specific intent requirement to distinguish innocent transfers of multi-purpose items from illegal transfers of drug paraphernalia.'' Id. Specific intent means that it is not just foreseeable that the material will be used to inject controlled substances in violation of the Drug Act, but that is the purpose, object, plan, or goal of the person distributing the needle or syringe. Needles and syringes have many lawful uses including injecting insulin, allergy serums, fertility drugs, blood thinners, migraine medications, Epinephrine, lawfully prescribed steroids, vitamins and other additives in total parenteral nutrition, and use in home IV therapy. It can be argued that the specific intent of a pharmacist is to distribute syringes to use in conformity with law. Pharmacists cannot be held to reasonably know or believe that anyone purchasing needles and syringes without a prescription is using them to inject controlled substances. PMS also noted that the age limit and number of syringes should be eliminated as restrictions. The Board agrees and has amended the final-form rulemaking to eliminate those restrictions. Finally, PMS stated that more information be gathered from other states where needles and syringes are available over the counter regarding how they address the previously-mentioned issues and their results. The Board has been monitoring this topic going back to 2002. Since the Board first undertook the proposed package, the Commonwealth is now one of only three states to still have a prescription requirement. The first states to remove this requirement did so back in the 1990s. The Board has gathered volumes of information about the efficacy of removing the requirement of a prescription to obtain needles and syringes in a pharmacy and is confident that it is prepared to address any issues that may arise with the amendment of the Board's regulations.
Several commentators wrote solely to express their support of the proposed amendment. These commentators included medical practitioners and educators. The Board thanks these commentators for their time and efforts in supporting this important amendment.
The amendment 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)).
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have no fiscal impact on the Board or the regulated community.
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 the notice of proposed rulemaking, published at 37 Pa.B. 4652, 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 23, 2009, the final-form rulemaking was approved by the HPLC. On July 22, 2009, 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 23, 2009, and approved the final-form rulemaking.
Individuals who need information about the rulemaking 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 an amendment in § 27.18, 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 (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) 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 amendment published at 37 Pa.B. 4652.
The Board therefore orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending § 27.18 to read as set forth in Annex A, with ellipses referring to the existing text of the regulation.
(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 39 Pa.B. 4832 (August 8, 2009).)
Fiscal Note: Fiscal Note 16A-5418 remains valid for the final adoption of the subject regulation.
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
§ 27.18. Standards of practice.
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(s) Sales of hypodermic needles and syringes shall be made by a pharmacist or under the direct, immediate and personal supervision of a pharmacist in accordance with the following:
(1) Hypodermic needles and syringes may be sold without a prescription.
(2) 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.
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[Pa.B. Doc. No. 09-1681. Filed for public inspection September 11, 2009, 9:00 a.m.]
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