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                                                      PRINTER'S NO. 4297

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 2803 Session of 2004


        INTRODUCED BY ALLEN, BELFANTI, THOMAS, GOODMAN, BAKER, BROWNE,
           CAPPELLI, CRAHALLA, DAILEY, GEORGE, HALUSKA, HERSHEY, HESS,
           LYNCH, MANN, McILHATTAN, R. MILLER, MUNDY, NICKOL, PHILLIPS,
           READSHAW, REICHLEY, SCAVELLO, SCHRODER, STABACK,
           E. Z. TAYLOR, J. TAYLOR, TIGUE, WALKO AND YOUNGBLOOD,
           JULY 3, 2004

        REFERRED TO COMMITTEE ON INSURANCE, JULY 3, 2004

                                     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
    17  Section 501.  Duties of Attorney General.

     1  Section 502.  Penalties.
     2  Chapter 11.  Miscellaneous Provisions
     3  Section 1101.  Effective date.
     4     The General Assembly of the Commonwealth of Pennsylvania
     5  hereby enacts as follows:
     6                             CHAPTER 1
     7                       PRELIMINARY PROVISIONS
     8  Section 101.  Short title.
     9     This act shall be known and may be cited as the Registration
    10  of Online Pharmacy Act.
    11  Section 102.  Legislative intent.
    12     It is the intent of the General Assembly to regulate
    13  pharmacies, manufacturers and wholesalers located outside this
    14  Commonwealth that transact business through the use of the
    15  Internet in Pennsylvania. Because the health, safety and welfare
    16  of patients within Pennsylvania is of paramount importance, the
    17  Office of Attorney General is entrusted with the enforcement of
    18  this act.
    19  Section 103.  Definitions.
    20     The following words and phrases when used in this act shall
    21  have the meanings given to them in this section unless the
    22  context clearly indicates otherwise:
    23     "Foreign jurisdiction."  A state other than Pennsylvania and
    24  the District of Columbia.
    25     "Nonresident establishment."  A person located outside this
    26  Commonwealth who advertises for sale or sells drugs or devices
    27  to patients in this Commonwealth by use of the Internet.
    28  Section 104.  Scope.
    29     This act shall apply to a person who, being located outside
    30  this Commonwealth, advertises for sale or sells drugs or devices
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     1  to patients within this Commonwealth by use of the Internet.
     2                             CHAPTER 3
     3                            REGISTRATION
     4  Section 301.  Registration required.
     5     A nonresident establishment shall register with the Office of
     6  Attorney General as provided in this act.
     7  Section 302.  Service of process.
     8     A nonresident establishment shall designate a resident agent
     9  in this Commonwealth for service of process and shall provide
    10  the appropriate contact information to the Office of Attorney
    11  General.
    12  Section 303.  Conditions of registration.
    13     (a)  General rule.--In order to be registered by the Office
    14  of Attorney General, a nonresident establishment shall:
    15         (1)  Be licensed or registered and in good standing with
    16     applicable regulatory agencies in the foreign jurisdiction.
    17         (2)  Maintain, in readily retrievable form, records of
    18     drugs or devices sold or offered for sale in this
    19     Commonwealth.
    20         (3)  Supply, upon request, all information needed by the
    21     Office of Attorney General to carry out the office's
    22     responsibilities under this act.
    23         (4)  Comply with the statutory and regulatory
    24     requirements of the foreign jurisdiction where the
    25     nonresident establishment is located, for prescription drugs
    26     or devices shipped, mailed or delivered to this Commonwealth,
    27     except for controlled substances shipped, mailed or delivered
    28     to the Commonwealth, for which the nonresident establishment
    29     shall follow Federal and Commonwealth laws relative to
    30     controlled substances.
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     1         (5)  Provide a toll-free telephone number that is
     2     available during normal business hours and at least 40 hours
     3     a week so that a patient in this Commonwealth may communicate
     4     with a pharmacist at the nonresident establishment.
     5         (6)  Have a registered pharmacist in good standing with
     6     the foreign jurisdiction employed to fill prescriptions for
     7     controlled substances offered for sale or sold in this
     8     Commonwealth.
     9         (7)  Pay the appropriate fee.
    10         (8)  Comply with other requirements the Office of
    11     Attorney General deems appropriate.
    12  Section 304.  Duration of registration; fee.
    13     (a)  Duration.--Registration shall be renewable biannually.
    14     (b)  Fee.--A fee of $1,000 shall be required biannually.
    15                             CHAPTER 5
    16                     ENFORCEMENT AND VIOLATIONS
    17  Section 501.  Duties of Attorney General.
    18     (a)  Enforcement.--Notwithstanding any provision of law to
    19  the contrary, the Office of Attorney General shall exclusively
    20  enforce the provisions of this act.
    21     (b)  Forms.--The Office of Attorney General shall develop a
    22  registration form for a nonresident establishment seeking to be
    23  registered pursuant to this act.
    24     (c)  Injunction.--The Office of Attorney General shall have
    25  the power to seek injunctive relief in a court of competent
    26  jurisdiction for attempted violations or violations of this act.
    27     (d)  Revocation.--The Office of Attorney General shall have
    28  the power to suspend or revoke the registration of a nonresident
    29  establishment which violates this act.
    30     (e)  Reports.--Within two years of the effective date of this
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     1  act and annually thereafter, the Office of Attorney General
     2  shall report to the General Assembly the following:
     3         (1)  The number of nonresident establishments registered
     4     under this act.
     5         (2)  The quantity and type of drugs and devices sold to
     6     patients within this Commonwealth by nonresident
     7     establishments.
     8         (3)  Any recommended changes to this act.
     9     (f)  Regulations.--The Office of Attorney General shall
    10  promulgate regulations necessary to carry out the provisions of
    11  this act.
    12  Section 502.  Penalties.
    13     (a)  Criminal penalty.--A nonresident establishment which
    14  knowingly or recklessly violates any provision of this act
    15  commits a misdemeanor of the first degree.
    16     (b)  Civil penalties.--In addition to any penalty imposed
    17  pursuant to this act, a nonresident establishment may be
    18  assessed a civil penalty of not more than $10,000 for each
    19  separate violation of this act. This penalty may be assessed by
    20  the Office of Attorney General. Penalties assessed shall be
    21  reviewable in accordance with 2 Pa.C.S. (relating to
    22  administrative law and procedure).
    23                             CHAPTER 11
    24                      MISCELLANEOUS PROVISIONS
    25  Section 1101.  Effective date.
    26     This act shall take effect in 60 days.



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