[Second Reprint]

 

ASSEMBLY, No. 3289

 

STATE OF NEW JERSEY

 

211th LEGISLATURE

 

INTRODUCED SEPTEMBER 27, 2004

 

 

 

Sponsored by:

Assemblyman FREDERICK SCALERA

District 36 (Bergen, Essex and Passaic)

Assemblywoman LINDA R. GREENSTEIN

District 14 (Mercer and Middlesex)

Assemblyman JOHN F. MCKEON

District 27 (Essex)

Assemblywoman JOAN VOSS

District 38 (Bergen)

 

Co-Sponsored by:

Assemblymen Gordon and Conners

 

 

 

 

SYNOPSIS

    Regulates Internet pharmacies and electronic prescriptions.

 

CURRENT VERSION OF TEXT

    As amended by the General Assembly on November 15, 2004.

 

(Sponsorship Updated As Of: 12/14/2004)


An Act concerning Internet pharmacies and electronic prescriptions 1[and] ,1 2amending and2 supplementing 1[chapter 14 of Title 45 of the Revised Statutes] P.L.2003, c.280 (C.45:14-40 et seq.) and making an appropriation1.

 

    Be It Enacted by the Senate and General Assembly of the State of New Jersey:

 

    1. (New section) As used in this act:

    "Board" means the Board of Pharmacy of the State of New Jersey.

    "Electronic prescription" means a prescription 2[generated by means of the Internet, facsimile or electronic mail] which is transmitted by a computer device in a secure manner, including computer to computer and computer to facsimile transmissions.

    "Facsimile prescription" means a prescription which is transmitted by a device which sends an exact image to the receiver2.

    "Internet" means the international network of interconnected government, educational and commercial computer networks.

    "Internet pharmacy" means a pharmacy located in the United States which maintains an Internet site for the purpose of soliciting and receiving prescription drug orders to be delivered to the patient by means of the United States Postal Service or other delivery service.

    "New Jersey patient" means a person who resides in New Jersey and requests delivery of a prescription drug order to an address in New Jersey.

    "Practitioner" means a duly licensed physician, dentist, optometrist, veterinarian, certified nurse midwife, advanced practice nurse or physician assistant, or other health care practitioner licensed or approved to write prescriptions 1[pursuant to R.S.45:14-14]1.

    "Prescription" or "prescription drug order" means any order for drugs and related items which meets the definition of "prescription" as that term is defined in 1[R.S.45:14-14] section 2 of P.L.2003, c.280 (C.45:14-41)1 and includes 1[an] a facsimile and1 electronic prescription 2[1, except for controlled dangerous substances schedules II, III, IV, and V which will require the proper documentation as required by federal law1]2.

    "Prescription drug" means a drug the label of which bears a statement that it is to be dispensed only by or on the prescription of a person licensed to prescribe drugs, or words of similar or like import, or a drug that requires a prescription or order by an authorized prescriber in order to be dispensed.

    "Professional judgment" means judiciousness and discretion based upon thorough knowledge and sound application of the specialized body of knowledge peculiar to the practice of pharmacy, and an understanding of the relationship of this knowledge and its application to the well-being of the patient and to the judgment of the prescriber.

    2[1"Verified Internet pharmacy" means, with respect to a particular consumer: an Internet pharmacy which is permitted to dispense drugs to citizens of this State without violating the laws of this State or the United States government; or an Internet pharmacy which is certified by the National Association of Boards of Pharmacy under the "Verified Internet Pharmacy Practice Sites" program.1]2

 

    2. (New section) 2a.2 An Internet pharmacy shall not dispense or deliver prescription drugs to a New Jersey patient unless the pharmacy applies to the board and 1[becomes registered] obtains a pharmacy permit1 to dispense and deliver prescription drugs in New Jersey in accordance with this act.

    2b. The provisions of this act shall not apply to an Internet pharmacy certified under the Verified Internet Pharmacy Practice Sites Certification Process of the National Association of Boards of Pharmacy.2

 

    3. (New section) The board shall 1[issue registration to] 2[ license1] issue a permit to2 an Internet pharmacy that satisfactorily meets the following requirements:

    a. 1has its corporate headquarters in the United States;

    b. submits an application to the board on the form that the board requires;

    c. submits a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the pharmacy is located;

    d.1 provides certification that it is licensed and in good standing in the state in which it is located;

    1[b.] e.1 provides the names, titles and addresses of all principal corporate officers;

    1[c.] f.1 provides the names and addresses of all of its pharmacists and certification that the pharmacists are registered and in good standing in the state where they work;

    1[d.] g.1 provides all other information deemed necessary by the board to ensure that the Internet pharmacy is qualified to dispense or deliver prescription drugs to New Jersey patients; and

    1[e.] h.1 pays any necessary application and 2[registration] permit2 fees as are required by the board.

    The 1[registration] 2[licensure1] permit2 shall be 2[valid]2 1[for a two-year period]1 2[and]2 1[shall be]1 renewed 1annually1 in accordance with 1[procedures adopted by]1 2[the 1usual1 board 1pharmacy permit requirements1] regulations adopted by the board2.

 

    4. (New section) An Internet pharmacy 1[registered] 2[licensed1] issued a permit2 in this State shall:

    a. 1comply with the laws of the state in which it is located;

    b. 2[on an annual basis and]2 within 30 days after a change of office, corporate officer, or pharmacist, disclose to the board the location, names and titles of all principal corporate officers and all pharmacists who are dispensing prescriptions for drugs or devices 2[in] for delivery into2 this State;

    c. comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which the pharmacy is located and all requests made by the board pursuant to this section;

    d. maintain at all times a valid, unexpired permit to operate a pharmacy in compliance with the laws of the state in which it is located;

    e.1 ensure that all prescription drug orders for New Jersey patients are filled by pharmacists 2[registered] licensed2 and in good standing in the state where the prescription is filled;

    1[b.] f.1 maintain in readily-retrievable form the records of New Jersey patients; 1[and]1

    1[c.] g.1 provide a toll-free telephone number for consultations between New Jersey patients and a 2[registered] licensed2 pharmacist who has ready access to the patient's records. The toll-free telephone number must be answered during normal business hours for a minimum of 1[40] 481 hours 1,six days1 per week. The toll-free telephone number must be on the label of every prescription drug delivered to New Jersey and prominently displayed on the pharmacy's Internet site 1; 2[and]2

    h. comply with the laws of this State relating to the confidentiality of prescription records if there are no laws relating to the confidentiality of prescription records in the state in which the Internet pharmacy is located1 2; and

    i. dispense drugs for delivery into this State pursuant to a prescription electronically transmitted only if the transmission is an electronic prescription or facsimile prescription conforming to the requirements of the board 2.

 

    5. (New section) An Internet pharmacy 2[registered] issued a permit2 in this State shall not:

    a. disclaim, limit or waive any liability to which a retail pharmacy in New Jersey is subject;

    b. disclaim, limit or waive the jurisdiction of the courts of the State of New Jersey; or

    c. disclaim, limit or waive the application of the laws of the State of New Jersey.

    Any disclaimer, limitation or waiver in violation of this section is void.

 

    16. (New section) The following are violations of this act:

    a. Dispensing, or arranging for the dispensing of a prescription drug to a consumer unless the person or business that packages, delivers, or otherwise furnishes the drug for use by the consumer:

    (1) has a valid pharmacy license issued by the board; 2or2

    (2) is a health care professional acting within the scope of his license within this State 2[; or

    (3) is a verified Internet pharmacy]2.

    b. Soliciting, assisting or enabling consumers to obtain a prescription via the Internet without a bona-fide existing practitioner-patient relationship. For purposes of this section, a bona-fide existing practitioner-patient relationship means:

     2[(1) the patient has retained the services of the practitioner and has personally met with the practitioner;

    (2) the practitioner has undertaken responsibility for making medical judgments regarding the health of the patient and the need for medical treatment;

    (3) the practitioner has sufficient knowledge of the patient, including a reliable medical history, to make a finding that the prescription drug is medically indicated;

    (4) the practitioner and patient have discussed orally the prescription drug's benefits and risks; and

    (5) the practitioner is available for follow-up care in order to assess patient outcome and in case of an adverse reaction to the drug.1]

    the practitioner has conducted an examination, which shall be appropriately documented in the patient record. As part of the patient examination, the practitioner shall:

    (1) perform an appropriate history and physical examination;

    (2) make a diagnosis based upon the examination and all diagnostic and laboratory tests consistent with good medical care;

    (3) formulate a therapeutic plan and discuss that plan, along with the basis for the plan and the risks and benefits of various treatment options, with the patient; and

    (4) ensure the availability of the physician or coverage for the patient for appropriate follow-up care.2

 

    1[6. a. Before dispensing or delivering prescription drugs to a New Jersey patient in accordance with an electronic prescription, the pharmacist or pharmacy shall ascertain that it is a legal and valid prescription written by a practitioner with a bona fide existing practitioner-patient relationship with the New Jersey patient. For purposes of this section, a bona fide existing practitioner-patient relationship means:

    (1) the patient has retained the services of the practitioner,

    (2) the practitioner has undertaken responsibility for making medical judgments regarding the health of the patient and the need for medical treatment,

    (3) the practitioner has sufficient knowledge of the patient, including a reliable medical history, to make a finding that the prescription drug is medically indicated,

    (4) the practitioner and patient have discussed orally the prescription drug's benefits and risks, and

    (5) the practitioner is available for follow-up care in order to assess patient outcome and in case of an adverse reaction to the drug.

    b. A pharmacy which violates the provisions of this section is subject to a civil penalty of $25,000 for each occurrence and a pharmacist is subject to a civil penalty of $5,000 for each occurrence. The Attorney General may bring an action in accordance with the "Penalty Enforcement Law of 1999, " P.L.1999, c.274 (C.2A: 58-10 et seq.), to enforce this section and to collect the civil penalties authorized herein.]

    7. (New section) 2a.2 A violation of this act is an unfair or deceptive trade practice in this State. Persons or businesses violating this act shall be subject to a civil penalty of $25,000 for each occurrence and a pharmacist is subject to a civil penalty of $5,000 for each occurrence. The Attorney General may bring an action in accordance with the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.), to enforce this section and to collect the civil penalties authorized herein.

    In addition to such other penalties as may apply, a consumer aggrieved by violation of this act may:

    2[a.] (1)2 obtain an injunction or such equitable relief as the court may find to be appropriate; and

    2[b.] (2)2 obtain liquidated damages of $10,000 per violation, in addition to court costs, attorney fees, and the reasonable costs of litigation.

    In addition to such penalties as may apply, a consumer who is injured by a prescription drug purchased through the Internet may bring an action for compensatory damages against a person who violated this act with respect to the purchase of that prescription drug by the consumer. Attorneys fees, court costs, and reasonable costs of litigation may be awarded by the court.

    2b. A violation of any of the provisions of this act shall be grounds for revoking or refusing to issue a permit to an Internet pharmacy as provided in this act.

    c.2 Nothing in this act shall be construed to prevent or limit the board, the Director of the Division of Consumer Affairs in the Department of Law and Public Safety or the Attorney General from taking any other action permitted by law against an Internet pharmacy.1

    2d. Nothing in this act shall be construed to prevent or limit the board from taking any action permitted by law against a person, other than a pharmacy, violating the provisions of this act for aiding and abetting the unlawful practice of pharmacy.2

 

    1[7.] 8.1 (New section) Whenever a pharmacist has reason to question the validity of an electronic prescription 2or a facsimile prescription2 for a New Jersey patient, the pharmacist shall verify the prescription directly with the prescribing practitioner. The pharmacist shall refuse to fill a prescription if, in his professional judgment:

    a. the prescription is outside the scope of practice of 2the license of 2 the prescriber;

    b. the pharmacist has sufficient reason to question the validity of the prescription; or

    c. refusal to fill the prescription is necessary to protect the health and welfare of the patient.

 

    1[8. A violation of any of the provisions of this act shall be grounds for revoking or refusing to grant registration to an Internet pharmacy as provided in this act.

    Nothing in this act shall be construed to prevent or limit the board, the Director of the Division of Consumer Affairs in the Department of Law and Public Safety or the Attorney General from taking any other action permitted by law against an Internet pharmacy.]1

 

    29. (New section) Notwithstanding the provisions of section 19 of P.L.2003, c.280 (C.45:14-58), to the contrary, the provisions of this act shall not permit a prescription to be given or transmitted to any pharmacist for any schedule II, III, IV or V controlled dangerous substances in any other manner than in writing signed by the practitioner.2

 

    210. Section 34 of P.L.2003, c.280 (C.45:14-73) is amended to read as follows:

    34. Any pharmacy located in another state , other than a pharmacy that is solely an Internet pharmacy, which ships, mails, distributes or delivers in any manner, legend drugs or devices pursuant to a prescription into this State, shall register with the board and provide the board with the following information:

    (1)  The location, names and titles of all principal corporate officers of the pharmacy. A report containing this information shall be made on an annual basis and within 30 days after any change of office or corporate officer; and

    (2)  That it complies with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as with all requests for information made by the board pursuant to this section. As a prerequisite to registering with the board, the pharmacy shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located.

    The annual registration fee shall be established by the board and shall not exceed $500 annually.

    Any pharmacy subject to this section shall, during its regular hours of operation, but not less than six days per week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this State and [a] pharmacists at a pharmacy who has access to the patient's records. This toll-free number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this State.2

(cf: P.L.2003, c.280, s.34)

 

    2[9.] 11. (New section)2 The Board of Pharmacy of the State of New Jersey, in 2[conjunction] consultation2 with the State Board of Medical Examiners, shall promulgate, in accordance with the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), such rules and regulations as may be necessary to effectuate the purposes of this act.

 

    2[110.] 12. (New section)2 There is hereby appropriated to the Division of Consumer Affairs in the Department of Law and Public Safety the sum of $99,000 for the purpose of offering an educational program to consumers regarding the 2safe and effective2 use of Internet pharmacy sites.1

 

    1[10.] 2[11.1]13.2 This act shall take effect on the 180th day after enactment; however, the board may take such action in advance as shall be necessary for the implementation of the act.