PRINTER'S NO. 686
No. 613 Session of 2005
INTRODUCED BY ALLEN, THOMAS, BELFANTI, GOODMAN, ARGALL, BAKER, BALDWIN, BASTIAN, BOYD, BROWNE, BUNT, CALTAGIRONE, CAPPELLI, CLYMER, CRAHALLA, CURRY, DALEY, FRANKEL, GERGELY, GINGRICH, HARRIS, HERSHEY, HESS, LEDERER, McILHATTAN, R. MILLER, MUSTIO, O'NEILL, PHILLIPS, PICKETT, REICHLEY, RUBLEY, SCHRODER, STABACK, E. Z. TAYLOR, TIGUE, WALKO, WATSON, WILT, WRIGHT AND YOUNGBLOOD, FEBRUARY 16, 2005
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, FEBRUARY 16, 2005
AN ACT 1 Regulating certain pharmacies, manufacturers and wholesalers 2 that advertise for sale or sell drugs or devices via the 3 Internet; providing for powers and duties of the Office of 4 Attorney General; and imposing penalties. 5 TABLE OF CONTENTS 6 Chapter 1. Preliminary Provisions 7 Section 101. Short title. 8 Section 102. Legislative intent. 9 Section 103. Definitions. 10 Section 104. Scope. 11 Chapter 3. Registration 12 Section 301. Registration required. 13 Section 302. Service of process. 14 Section 303. Conditions of registration. 15 Section 304. Duration of registration; fee. 16 Chapter 5. Enforcement and Violations
1 Section 501. Duties of Attorney General. 2 Section 502. Penalties. 3 Chapter 11. Miscellaneous Provisions 4 Section 1101. Effective date. 5 The General Assembly of the Commonwealth of Pennsylvania 6 hereby enacts as follows: 7 CHAPTER 1 8 PRELIMINARY PROVISIONS 9 Section 101. Short title. 10 This act shall be known and may be cited as the Registration 11 of Online Pharmacy Act. 12 Section 102. Legislative intent. 13 It is the intent of the General Assembly to regulate 14 pharmacies, manufacturers and wholesalers located outside this 15 Commonwealth that transact business through the use of the 16 Internet in Pennsylvania. Because the health, safety and welfare 17 of patients within Pennsylvania is of paramount importance, the 18 Office of Attorney General is entrusted with the enforcement of 19 this act. 20 Section 103. Definitions. 21 The following words and phrases when used in this act shall 22 have the meanings given to them in this section unless the 23 context clearly indicates otherwise: 24 "Foreign jurisdiction." A state other than Pennsylvania and 25 the District of Columbia. 26 "Nonresident establishment." A person located outside this 27 Commonwealth who advertises for sale or sells drugs or devices 28 to patients in this Commonwealth by use of the Internet. 29 Section 104. Scope. 30 This act shall apply to a person who, being located outside 20050H0613B0686 - 2 -
1 this Commonwealth, advertises for sale or sells drugs or devices 2 to patients within this Commonwealth by use of the Internet. 3 CHAPTER 3 4 REGISTRATION 5 Section 301. Registration required. 6 A nonresident establishment shall register with the Office of 7 Attorney General as provided in this act. 8 Section 302. Service of process. 9 A nonresident establishment shall designate a resident agent 10 in this Commonwealth for service of process and shall provide 11 the appropriate contact information to the Office of Attorney 12 General. 13 Section 303. Conditions of registration. 14 (a) General rule.--In order to be registered by the Office 15 of Attorney General, a nonresident establishment shall: 16 (1) Be licensed or registered and in good standing with 17 applicable regulatory agencies in the foreign jurisdiction. 18 (2) Maintain, in readily retrievable form, records of 19 drugs or devices sold or offered for sale in this 20 Commonwealth. 21 (3) Supply, upon request, all information needed by the 22 Office of Attorney General to carry out the office's 23 responsibilities under this act. 24 (4) Comply with the statutory and regulatory 25 requirements of the foreign jurisdiction where the 26 nonresident establishment is located, for prescription drugs 27 or devices shipped, mailed or delivered to this Commonwealth, 28 except for controlled substances shipped, mailed or delivered 29 to the Commonwealth, for which the nonresident establishment 30 shall follow Federal and Commonwealth laws relative to 20050H0613B0686 - 3 -
1 controlled substances. 2 (5) Provide a toll-free telephone number that is 3 available during normal business hours and at least 40 hours 4 a week so that a patient in this Commonwealth may communicate 5 with a pharmacist at the nonresident establishment. 6 (6) Have a registered pharmacist in good standing with 7 the foreign jurisdiction employed to fill prescriptions for 8 controlled substances offered for sale or sold in this 9 Commonwealth. 10 (7) Pay the appropriate fee. 11 (8) Comply with other requirements the Office of 12 Attorney General deems appropriate. 13 Section 304. Duration of registration; fee. 14 (a) Duration.--Registration shall be renewable biannually. 15 (b) Fee.--A fee of $1,000 shall be required biannually. 16 CHAPTER 5 17 ENFORCEMENT AND VIOLATIONS 18 Section 501. Duties of Attorney General. 19 (a) Enforcement.--Notwithstanding any provision of law to 20 the contrary, the Office of Attorney General shall exclusively 21 enforce the provisions of this act. 22 (b) Forms.--The Office of Attorney General shall develop a 23 registration form for a nonresident establishment seeking to be 24 registered pursuant to this act. 25 (c) Injunction.--The Office of Attorney General shall have 26 the power to seek injunctive relief in a court of competent 27 jurisdiction for attempted violations or violations of this act. 28 (d) Revocation.--The Office of Attorney General shall have 29 the power to suspend or revoke the registration of a nonresident 30 establishment which violates this act. 20050H0613B0686 - 4 -
1 (e) Reports.--Within two years of the effective date of this 2 act and annually thereafter, the Office of Attorney General 3 shall report to the General Assembly the following: 4 (1) The number of nonresident establishments registered 5 under this act. 6 (2) The quantity and type of drugs and devices sold to 7 patients within this Commonwealth by nonresident 8 establishments. 9 (3) Any recommended changes to this act. 10 (f) Regulations.--The Office of Attorney General shall 11 promulgate regulations necessary to carry out the provisions of 12 this act. 13 Section 502. Penalties. 14 (a) Criminal penalty.--A nonresident establishment which 15 knowingly or recklessly violates any provision of this act 16 commits a misdemeanor of the first degree. 17 (b) Civil penalties.--In addition to any penalty imposed 18 pursuant to this act, a nonresident establishment may be 19 assessed a civil penalty of not more than $10,000 for each 20 separate violation of this act. This penalty may be assessed by 21 the Office of Attorney General. Penalties assessed shall be 22 reviewable in accordance with 2 Pa.C.S. (relating to 23 administrative law and procedure). 24 CHAPTER 11 25 MISCELLANEOUS PROVISIONS 26 Section 1101. Effective date. 27 This act shall take effect in 60 days. L21L12BIL/20050H0613B0686 - 5 -