House Study Bill 51 



                                       SENATE/HOUSE FILE       
                                       BY  (PROPOSED BOARD OF
                                            PHARMACY BILL)


    Passed Senate, Date               Passed House,  Date             
    Vote:  Ayes        Nays           Vote:  Ayes        Nays         
                 Approved                            

                                      A BILL FOR

  1 An Act relating to the practice of pharmacy by establishing a
  2    registration program for pharmacy support persons and
  3    regulating the internet sale of prescription products,
  4    including a program of registration of pharmacy internet
  5    sites, making penalties applicable, and establishing a general
  6    definition for the term "internet site".
  7 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
  8 TLSB 1416DP 83
  9 jr/rj/8

PAG LIN



  1  1    Section 1.  Section 4.1, Code 2009, is amended by adding
  1  2 the following new subsection:
  1  3    NEW SUBSECTION.  9B.  "Internet site" means a specific
  1  4 location on the internet that is determined by internet
  1  5 protocol numbers, by a domain name, or by both, including but
  1  6 not limited to domain names that use the designations ".com",
  1  7 ".edu", ".gov", ".org", and ".net".
  1  8    Sec. 2.  Section 155A.3, subsection 38, Code 2009, is
  1  9 amended to read as follows:
  1 10    38.  "Prescription drug order" means a written, electronic,
  1 11 or facsimile an order from transmitted, delivered, or
  1 12 otherwise communicated to a pharmacist by a practitioner or an
  1 13 oral order from as directed by a practitioner or the
  1 14 practitioner's authorized agent who communicates the
  1 15 practitioner's instructions in the authorized course of
  1 16 professional practice for a prescription drug or device to be
  1 17 dispensed.
  1 18    Sec. 3.  NEW SECTION.  155A.6B  PHARMACY SUPPORT PERSON
  1 19 REGISTRATION.
  1 20    1.  The board shall establish a registration program for
  1 21 pharmacy support persons who work in a licensed pharmacy and
  1 22 who are not licensed pharmacists or registered pharmacy
  1 23 technicians for the purposes of identification, tracking, and
  1 24 disciplinary action for the violation of federal drug laws or
  1 25 regulations, state drug or pharmacy laws, or board rules.  The
  1 26 registration shall not include any determination of the
  1 27 competency of the registered individual and, notwithstanding
  1 28 section 272C.2, subsection 1, shall not require continuing
  1 29 education for renewal.
  1 30    2.  A person registered with the board as a pharmacy
  1 31 support person may assist pharmacists by performing routine
  1 32 clerical and support functions.  Such a person shall not
  1 33 perform any professional duties or any technical or dispensing
  1 34 duties.  The ultimate responsibility for the actions of a
  1 35 pharmacy support person working under a licensed pharmacist's
  2  1 supervision shall remain with the licensed pharmacist.
  2  2    3.  Applicants for registration must apply to the board for
  2  3 registration on a form prescribed by the board.
  2  4    4.  The board shall adopt rules in accordance with chapter
  2  5 17A on matters pertaining to pharmacy support person
  2  6 registration, application, renewals, fees, termination of
  2  7 registration, training, and any other relevant matters.
  2  8    5.  The board may deny, suspend, or revoke the registration
  2  9 of a pharmacy support person or otherwise discipline the
  2 10 pharmacy support person for any violation of the laws of this
  2 11 state, another state, or the United States relating to
  2 12 prescription drugs, controlled substances, or nonprescription
  2 13 drugs, or for any violation of this chapter or chapter 124,
  2 14 124A, 124B, 126, 147, 205, or 272C, or any rule of the board.
  2 15    Sec. 4.  NEW SECTION.  155A.13B  PHARMACY INTERNET SITES.
  2 16    1.  As used in this section:
  2 17    a.  "Electronic mail" means any message transmitted through
  2 18 the internet including but not limited to messages transmitted
  2 19 from or to any address affiliated with an internet site.
  2 20    b.  "Internet broker" means an entity that serves as an
  2 21 agent or intermediary or other capacity that causes the
  2 22 internet to be used to bring together a buyer and seller.
  2 23    c.  "Internet sale" means a transaction, initiated via an
  2 24 internet site, that includes the order of and the payment for
  2 25 a prescription drug product.
  2 26    2.  A pharmacy operating within or outside this state shall
  2 27 not sell, dispense, distribute, deliver, or participate in the
  2 28 sale, dispensing, distribution, or delivery of any
  2 29 prescription drug to any patient in this state through an
  2 30 internet site or by electronic mail unless all of the
  2 31 following are met:
  2 32    a.  All internet sites and electronic mail used by the
  2 33 pharmacy for purposes of sales or delivery of a
  2 34 prescription=only drug are in compliance with all requirements
  2 35 of federal law applicable to the site or electronic mail.
  3  1    b.  (1)  The pharmacy that sells, dispenses, distributes,
  3  2 or delivers the prescription=only drugs is in compliance with
  3  3 all requirements of relevant state law.
  3  4    (2)  The pharmacy is properly licensed and regulated by the
  3  5 board to operate a pharmacy pursuant to section 155A.13 or
  3  6 155A.13A.
  3  7    c.  The pharmacist who fills the prescription drug order is
  3  8 not in violation of subsection 4.
  3  9    d.  (1)  The pharmacy is not in violation of subsection 6.
  3 10    (2)  The pharmacy is in compliance with an Iowa
  3 11 prescription drug monitoring program if an Iowa prescription
  3 12 drug monitoring program exists and the pharmacy is subject to
  3 13 reporting or other requirements of the program.
  3 14    3.  A practitioner who writes a prescription drug order
  3 15 through an internet site or electronic mail for a patient
  3 16 physically located in this state must be licensed by the
  3 17 applicable licensing authority and in compliance with all
  3 18 applicable laws.
  3 19    4.  A pharmacist practicing within or outside this state
  3 20 shall not fill a prescription drug order to dispense a
  3 21 prescription drug to a patient if the pharmacist knows or
  3 22 reasonably should have known under the circumstances that the
  3 23 prescription drug order was issued under both of the
  3 24 following:
  3 25    a.  Solely on the basis of an internet questionnaire, an
  3 26 internet consultation, or a telephonic consultation.
  3 27    b.  Without a prior valid patient=practitioner
  3 28 relationship.
  3 29    5.  An internet broker operating within or outside this
  3 30 state may participate in the sale of a prescription drug in
  3 31 this state only if the internet broker knows that the
  3 32 pharmacist who dispenses the drug is not in violation of
  3 33 subsection 4.
  3 34    6.  A pharmacy shall not sell, dispense, distribute,
  3 35 deliver, or participate in the sale, dispensing, distribution,
  4  1 or delivery of any prescription=only drug to a consumer in
  4  2 this state if any part of the transaction was conducted
  4  3 through an internet site unless the internet site displays in
  4  4 a clear and conspicuous manner all of the following:
  4  5    a.  The name of the pharmacy.
  4  6    b.  The address of the licensed physical location of the
  4  7 pharmacy.
  4  8    c.  The telephone number of the pharmacy.
  4  9    d.  The license number issued by the board to the pharmacy.
  4 10    e.  The certification issued by the national association of
  4 11 boards of pharmacy identifying the pharmacy as a verified
  4 12 internet pharmacy practice sites site, the verified internet
  4 13 pharmacy practice site's seal, and a link to the national
  4 14 association of boards of pharmacy's verification site, except
  4 15 that verified internet pharmacy practice sites certification
  4 16 shall not be required of a pharmacy that utilizes an internet
  4 17 site for the convenience of a patient to request a
  4 18 prescription refill or to request or retrieve drug information
  4 19 but requires that the filled prescription be delivered to the
  4 20 patient at the licensed physical location of the pharmacy.
  4 21    f.  The internet site registration number issued by the
  4 22 board.
  4 23    7.  A pharmacy that sells, dispenses, distributes,
  4 24 delivers, prescribes, or participates in the sale, dispensing,
  4 25 distribution, or delivery of any prescription drug to any
  4 26 patient in this state, if the patient submitted the purchase
  4 27 order for the prescription drug through an internet site or by
  4 28 electronic mail, shall not disclaim, limit, or waive any
  4 29 liability to which the pharmacy otherwise is subject under law
  4 30 for the act or practice of selling, dispensing, distributing,
  4 31 or delivering prescription drugs.
  4 32    8.  A disclaimer, limitation, or waiver in violation of
  4 33 this section is void.
  4 34    9.  An attempt to make a disclaimer, limitation, or waiver
  4 35 in violation of this section is a violation of this chapter.
  5  1    10.  For purposes of this section, the board shall adopt
  5  2 rules in accordance with chapter 17A on matters pertaining to
  5  3 internet site registration, application, forms, renewals,
  5  4 fees, termination of registration, and any other relevant
  5  5 matters.
  5  6    Sec. 5.  Section 155A.27, unnumbered paragraph 1, Code
  5  7 2009, is amended to read as follows:
  5  8    Each To be valid, each prescription drug order issued or
  5  9 filled dispensed in this state must be based on a prior valid
  5 10 patient=practitioner relationship, and:
  5 11    Sec. 6.  Section 155A.29, Code 2009, is amended by adding
  5 12 the following new subsection:
  5 13    NEW SUBSECTION.  4.  An authorization to refill a
  5 14 prescription drug order may be transmitted to a pharmacist by
  5 15 a prescriber or the prescriber's agent through word of mouth,
  5 16 note, telephone, facsimile, or other means of communication
  5 17 initiated by or directed by the practitioner.  The
  5 18 transmission shall include the information required pursuant
  5 19 to section 155A.27 and, if not transmitted directly by the
  5 20 practitioner, shall identify by name and title the
  5 21 practitioner's agent completing the transmission.
  5 22                           EXPLANATION
  5 23    This bill establishes a registration program for pharmacy
  5 24 support persons who may perform only routine clerical and
  5 25 support functions.  A pharmacy support person shall not
  5 26 perform any professional duties or any technical or dispensing
  5 27 duties.
  5 28    The bill also establishes new requirements for the internet
  5 29 sale of prescription drugs by pharmacies.  In part, the bill
  5 30 prohibits a pharmacist from filling a prescription drug order
  5 31 from a provider if both of the following conditions are met:
  5 32    1.  The order is based solely on an internet questionnaire,
  5 33 an internet consultation, or a telephonic consultation.
  5 34    2.  A prior valid patient=practitioner relationship does
  5 35 not exist.
  6  1    The bill requires internet pharmacies to display certain
  6  2 information on their internet sites and requires them to
  6  3 obtain certification as a verified internet pharmacy practice
  6  4 site from the national association of boards of pharmacy.  The
  6  5 bill requires internet pharmacies to obtain an internet site
  6  6 registration from the board and prevents internet pharmacies
  6  7 from disclaiming, limiting, or waiving liability to which they
  6  8 otherwise would be subject under the law.
  6  9    The bill allows a prescriber or the prescriber's agent to
  6 10 authorize the refill of a prescription by any means of
  6 11 communication, including word of mouth.
  6 12    The bill also amends Code chapter 4, adding a general
  6 13 definition of the term "internet site".
  6 14 LSB 1416DP 83
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