House File 34 



                                       HOUSE FILE       
                                       BY  HEDDENS


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

                                      A BILL FOR

  1 An Act relating to the sale of a pseudoephedrine product by a
  2    pharmacy or retailer, and providing penalties and contingent
  3    applicability.
  4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
  5 TLSB 1251HH 83
  6 jm/rj/14

PAG LIN



  1  1    Section 1.  Section 124.212, subsection 4, paragraph c,
  1  2 Code 2009, is amended to read as follows:
  1  3    c.  Pseudoephedrine.  A person shall present a
  1  4 government=issued photo identification card when purchasing a
  1  5 pseudoephedrine product from a pharmacy.  A person shall not
  1  6 purchase more than seven thousand five hundred milligrams of
  1  7 pseudoephedrine, either separately or collectively, within a
  1  8 thirty=day period a quantity of pseudoephedrine in violation
  1  9 of section 124.213 from a pharmacy, unless the person has a
  1 10 prescription for a pseudoephedrine product in excess of that
  1 11 quantity.  A pseudoephedrine product not excepted from this
  1 12 schedule shall be sold by a pharmacy as provided in section
  1 13 124.212A.
  1 14    Sec. 2.  NEW SECTION.  124.212A  PHARMACY PSEUDOEPHEDRINE
  1 15 SALE == RESTRICTIONS == RECORDS == CONTINGENT APPLICABILITY.
  1 16    1.  A pharmacy, an employee of a pharmacy, or a licensed
  1 17 pharmacist shall do the following:
  1 18    a.  Provide for the sale of a pseudoephedrine product in a
  1 19 locked cabinet or behind the sales counter where the public is
  1 20 unable to reach the product and where the public is not
  1 21 permitted.
  1 22    b.  Require the purchaser to present a government=issued
  1 23 photo identification card identifying the purchaser prior to
  1 24 purchasing a pseudoephedrine product.
  1 25    c.  Provide an electronic logbook for purchasers of
  1 26 pseudoephedrine products to sign.
  1 27    d.  Require the purchaser to sign the electronic logbook.
  1 28 If the electronic logbook is not available, require a
  1 29 signature that is associated with a transaction number.
  1 30    e.  Enter the purchaser's name, address, date of purchase,
  1 31 time of purchase, name of the pseudoephedrine product
  1 32 purchased, and the quantity sold in the electronic logbook.
  1 33 If the electronic logbook is unavailable, an alternative
  1 34 record shall be kept that complies with rules adopted by the
  1 35 board.
  2  1    f.  Determine that the signature in the electronic logbook
  2  2 corresponds with the name on the government=issued photo
  2  3 identification card.
  2  4    g.  Provide notice that a purchaser entering a false
  2  5 statement or misrepresentation in the electronic logbook may
  2  6 subject the purchaser to criminal penalties under 18 U.S.C. }
  2  7 1001.
  2  8    h.  Keep electronic logbook records and any other records
  2  9 obtained if the electronic logbook is unavailable for
  2 10 twenty=four months from the date of the last entry.
  2 11    i.  Disclose electronic logbook information and any other
  2 12 associated records as provided by state and federal law.
  2 13    j.  Comply with training requirements pursuant to federal
  2 14 law.
  2 15    2.  This section is not applicable unless sufficient
  2 16 funding is received to implement and maintain the statewide
  2 17 real=time central repository and the board establishes the
  2 18 statewide real=time central repository.  However, subsection
  2 19 1, paragraph "h" is applicable upon the effective date of this
  2 20 Act.
  2 21    Sec. 3.  NEW SECTION.  124.212B  PSEUDOEPHEDRINE SALES ==
  2 22 TRACKING == PENALTY == CONTINGENT APPLICABILITY.
  2 23    1.  The board shall establish a real=time electronic
  2 24 repository to monitor and control the sale of schedule V
  2 25 products containing any detectible amount of pseudoephedrine,
  2 26 its salts, or optical isomers, or salts of optical isomers;
  2 27 ephedrine; or phenylpropanolamine.  A pharmacy dispensing such
  2 28 products shall report all such sales electronically to a
  2 29 central repository under the control of the board.
  2 30    2.  The information collected in the central repository is
  2 31 confidential unless otherwise ordered by a court, or released
  2 32 by the lawful custodian of the records pursuant to this
  2 33 section.
  2 34    3.  A pharmacy, an employee of a pharmacy, or a licensed
  2 35 pharmacist shall not be provided access to the stored
  3  1 information in the electronic central repository, except for
  3  2 the purpose of obtaining sufficient information for a
  3  3 pharmacy, an employee of a pharmacy, or a licensed pharmacist
  3  4 to determine whether to complete the sale of the product.  A
  3  5 pharmacy, an employee of a pharmacy, or a licensed pharmacist
  3  6 shall not be given the obligation or duty to view the stored
  3  7 information.
  3  8    4.  A pharmacy, or an employee of a pharmacy, or a licensed
  3  9 pharmacist shall not be given the obligation or duty to seek
  3 10 information from the central repository if the real=time
  3 11 electronic logbook becomes unavailable for use.
  3 12    5.  If the electronic logbook is unavailable for use, a
  3 13 paper record for each sale shall be maintained including the
  3 14 purchaser's signature.  Any paper record maintained by the
  3 15 pharmacy shall be provided to the board for inclusion in the
  3 16 electronic real=time central repository as soon as
  3 17 practicable.
  3 18    6.  A pharmacy, or an employee of a pharmacy, or a licensed
  3 19 pharmacist shall not be liable, if acting reasonably and in
  3 20 good faith, to any person for any claim which may arise when
  3 21 reporting sales of products enumerated in subsection 1 to the
  3 22 central repository.
  3 23    7.  A person who discloses information stored in the
  3 24 central repository in violation of this section commits a
  3 25 simple misdemeanor.
  3 26    8.  The board shall adopt rules to administer this section.
  3 27    9.  This section is not applicable unless sufficient
  3 28 funding is received to implement and maintain this section and
  3 29 the board establishes the statewide real=time central
  3 30 repository.
  3 31    Sec. 4.  NEW SECTION.  124.212C  PSEUDOEPHEDRINE ADVISORY
  3 32 COUNCIL == ELECTRONIC MONITORING.
  3 33    1.  The board shall establish a pseudoephedrine advisory
  3 34 council to provide input and advise the board regarding the
  3 35 implementation and maintenance of the statewide real=time
  4  1 central repository established under section 124.212B to
  4  2 monitor sales of pseudoephedrine.  The board shall specify the
  4  3 duties, responsibilities, and other related matters of the
  4  4 council.
  4  5    2.  The council shall consist of four licensed pharmacists.
  4  6 The board shall solicit recommendations for membership on the
  4  7 council from the Iowa pharmacy association and Iowa retail
  4  8 federation, and shall appoint members from the
  4  9 recommendations.  The council shall include a member from an
  4 10 independent pharmacy, a member from a regional chain pharmacy,
  4 11 and a member from a national chain pharmacy.  The license of
  4 12 any member must be current and not subject to disciplinary
  4 13 sanctions.
  4 14    3.  The council may make recommendations regarding the
  4 15 implementation and maintenance of the statewide real=time
  4 16 central repository monitoring system under section 124.212B.
  4 17    4.  The council shall do the following:
  4 18    a.  Assist the board in implementing and maintaining the
  4 19 statewide real=time central repository monitoring system.
  4 20    b.  Assist the board in developing utilization guidance
  4 21 related to the statewide real=time central repository
  4 22 monitoring system and disseminating such guidance.
  4 23    c.  Assist the board in developing guidelines to ensure
  4 24 patient confidentiality and the integrity of the relationship
  4 25 established by the patient and the patient's health care
  4 26 provider.
  4 27    5.  All members of the council shall receive actual and
  4 28 necessary expenses incurred in the performance of their
  4 29 duties.
  4 30    Sec. 5.  Section 124.213, Code 2009, is amended by striking
  4 31 the section and inserting in lieu thereof the following:
  4 32    124.213  PSEUDOEPHEDRINE PURCHASE RESTRICTIONS FROM
  4 33 PHARMACY OR RETAILER == PENALTY.
  4 34    1.  A person shall not purchase more than three thousand
  4 35 six hundred milligrams of pseudoephedrine, either separately
  5  1 or collectively, within a twenty=four=hour period from a
  5  2 pharmacy, or more than one package of a product containing
  5  3 pseudoephedrine within a twenty=four=hour period from a
  5  4 retailer in violation of section 126.23A.
  5  5    2.  A person shall not purchase more than seven thousand
  5  6 five hundred milligrams of pseudoephedrine, either separately
  5  7 or collectively, within a thirty=day period from a pharmacy or
  5  8 from a retailer in violation of section 126.23A.
  5  9    3.  A person who violates this section commits a serious
  5 10 misdemeanor.
  5 11    Sec. 6.  Section 126.23A, subsection 1, paragraph a,
  5 12 subparagraph (1), Code 2009, is amended by striking the
  5 13 subparagraph and inserting in lieu thereof the following:
  5 14    (1)  Sell more than seven thousand five hundred milligrams
  5 15 of pseudoephedrine to the same person within a thirty=day
  5 16 period.
  5 17    Sec. 7.  Section 126.23A, subsection 1, paragraph b, Code
  5 18 2009, is amended to read as follows:
  5 19    b.  A retailer or an employee of a retailer shall do the
  5 20 following:
  5 21    (1)  Provide for the sale of a pseudoephedrine product in a
  5 22 locked cabinet or behind a sales counter where the public is
  5 23 unable to reach the product and where the public is not
  5 24 permitted.
  5 25    (2)  Require a purchaser to present a government=issued
  5 26 photo identification card identifying the purchaser prior to
  5 27 purchasing a pseudoephedrine product.
  5 28    (3)  Require the purchaser to sign a logbook and to also
  5 29 require the purchaser to legibly print the purchaser's name
  5 30 and address in the logbook.
  5 31    (4)  Print the name of the pseudoephedrine product
  5 32 purchased and quantity sold next to the name of each purchaser
  5 33 in the logbook.
  5 34    (4)  (5)  Determine the signature in the logbook
  5 35 corresponds with the name on the government=issued photo
  6  1 identification card.
  6  2    (5)  (6)  Keep the logbook twelve twenty=four months from
  6  3 the date of the last entry.
  6  4    (6)  (7)  Provide notification in a clear and conspicuous
  6  5 manner in a location where a pseudoephedrine product is
  6  6 offered for sale stating the following:
  6  7    Iowa law prohibits the over=the=counter purchase of more
  6  8 than one package of a product containing pseudoephedrine in a
  6  9 twenty=four=hour period or of more than seven thousand five
  6 10 hundred milligrams of pseudoephedrine within a thirty=day
  6 11 period.  If you purchase a product containing pseudoephedrine,
  6 12 you are required to sign a logbook which may be accessible to
  6 13 law enforcement officers.
  6 14    (8)  Provide notification affixed to the logbook stating
  6 15 that a purchaser entering a false statement or
  6 16 misrepresentation in the logbook may subject the purchaser to
  6 17 criminal penalties under 18 U.S.C. } 1001.
  6 18    (9)  Disclose logbook information as provided by state and
  6 19 federal law.
  6 20    (10)  Comply with training requirements pursuant to federal
  6 21 law.
  6 22    Sec. 8.  CONTINGENT APPLICABILITY == PHARMACY BOARD AND
  6 23 CODE EDITOR RESPONSIBILITIES.
  6 24    1.  The board of pharmacy examiners shall notify the Code
  6 25 editor when the establishment of the repository on a statewide
  6 26 basis is complete.
  6 27    2.  When the establishment of the central repository on a
  6 28 statewide basis is complete, the Code editor is directed to
  6 29 remove section 124.212A, subsection 2, and section 124.212B,
  6 30 subsection 9, from the Code and to internally renumber the
  6 31 sections as necessary.
  6 32                           EXPLANATION
  6 33    This bill relates to the sale of a pseudoephedrine product
  6 34 by a pharmacy or retailer.
  6 35    PENALTIES.  The bill provides that a person shall not
  7  1 purchase more than 3,600 milligrams of pseudoephedrine, either
  7  2 collectively or separately, within a 24=hour period from a
  7  3 pharmacy unless the person has a prescription.  A person who
  7  4 violates this provision of the bill commits a serious
  7  5 misdemeanor.  Under current law and the bill, a person commits
  7  6 a serious misdemeanor if the person purchases more than 7,500
  7  7 milligrams of pseudoephedrine within a 30=day period from a
  7  8 pharmacy or retailer.
  7  9    PHARMACY.  The bill requires a purchaser of a
  7 10 pseudoephedrine product from a pharmacy to sign an electronic
  7 11 logbook.  Current law does not require a signature in an
  7 12 electronic logbook.  The bill also provides that if the
  7 13 electronic logbook is unavailable, the pharmacy is required to
  7 14 keep an alternative record that complies with rules adopted by
  7 15 the state board of pharmacy examiners.
  7 16    The bill requires a pharmacy, an employee of a pharmacy, or
  7 17 a licensed pharmacist, to enter a purchaser's name, address,
  7 18 date of purchase, time of purchase, name of pseudoephedrine
  7 19 product, and quantity sold into an electronic logbook.  If the
  7 20 electronic logbook is unavailable for use, the bill requires
  7 21 the pharmacy to keep written records of the transaction
  7 22 including a signature.
  7 23    The bill requires a pharmacy to keep electronic logbook
  7 24 records for a period of 24 months from the date of the last
  7 25 entry.  Current law requires the pharmacy to keep the logbook
  7 26 12 months from the date of the last entry.
  7 27    The bill provides that the state board of pharmacy shall
  7 28 implement and maintain a statewide real=time central
  7 29 repository to track pseudoephedrine product sales at
  7 30 pharmacies.  The bill requires a pharmacy dispensing
  7 31 pseudoephedrine products to report all such sales
  7 32 electronically to the central repository under the control of
  7 33 the state board of pharmacy.  If the pharmacy has written
  7 34 records, the records are also to be reported for entry into
  7 35 the repository.  If the electronic logbook is unavailable for
  8  1 use, the bill requires the pharmacy to keep written records of
  8  2 the transaction including a signature.
  8  3    The bill makes confidential the information collected in
  8  4 the central repository unless otherwise ordered by a court, or
  8  5 the records are released by the custodian of the records
  8  6 pursuant to new Code section 124.212B.
  8  7    The bill provides that a pharmacy, an employee of a
  8  8 pharmacy, or a licensed pharmacist shall not be liable to any
  8  9 person for any claim which may arise when reporting in good
  8 10 faith pseudoephedrine sales to the central repository.
  8 11    The bill also requires a pharmacy to comply with training
  8 12 requirements pursuant to federal law.
  8 13    A person who discloses information stored in the central
  8 14 repository in violation of the bill commits a simple
  8 15 misdemeanor.
  8 16    RETAILER.  The bill requires a retailer or an employee of a
  8 17 retailer to print the name of the pseudoephedrine product
  8 18 purchased and the quantity sold next to the name of each
  8 19 purchaser in the logbook.
  8 20    The bill requires the retailer to keep the logbook 24
  8 21 months from the date of the last entry.  Current law requires
  8 22 the retailer to keep the logbook 12 months from the date of
  8 23 the last entry.  The bill does not require a retailer to keep
  8 24 an electronic logbook of pseudoephedrine purchases.
  8 25    The bill also requires a retailer to comply with training
  8 26 requirements pursuant to federal law.
  8 27    ADVISORY COMMITTEE.  The bill requires the board of
  8 28 pharmacy to establish a pseudoephedrine advisory council to
  8 29 provide input and advise the board regarding the
  8 30 implementation and maintenance of the statewide real=time
  8 31 central repository.  The advisory council shall consist of
  8 32 four licensed pharmacists including a pharmacist from an
  8 33 independent pharmacy, a regional chain pharmacy, and a
  8 34 national chain pharmacy.
  8 35    CONTINGENT APPLICABILITY.  New Code sections 124.212A and
  9  1 124.212B created in the bill do not become applicable until
  9  2 sufficient funding is received and the central repository
  9  3 under the control of the state board of pharmacy is
  9  4 established on a statewide basis.  However, Code section
  9  5 124.212A, subsection 1, paragraph "h", in the bill, which
  9  6 requires a pharmacy to keep logbook records 24 months from the
  9  7 date of the last entry, is applicable upon the effective date
  9  8 of the bill.
  9  9 LSB 1251HH 83
  9 10 jm/rj/14