House File 833 - Introduced
HOUSE FILE
BY COMMITTEE ON WAYS AND MEANS
(SUCCESSOR TO HF 790)
(SUCCESSOR TO HSB 227)
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act making changes relating to the practice of pharmacy,
2 establishing and appropriating fees, and providing penalties.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
4 TLSB 1292HZ 81
5 rn/pj/5
PAG LIN
1 1 Section 1. Section 155A.3, subsection 11, Code 2005, is
1 2 amended to read as follows:
1 3 11. "Dispense" means to deliver a prescription drug,
1 4 device, or controlled substance to an ultimate user or
1 5 research subject by or pursuant to the lawful prescription
1 6 drug order or medication order of a practitioner, including
1 7 the prescribing, administering, packaging, labeling, or
1 8 compounding necessary to prepare the substance for that
1 9 delivery.
1 10 Sec. 2. Section 155A.3, Code 2005, is amended by adding
1 11 the following new subsection:
1 12 NEW SUBSECTION. 23A. "Pedigree" means a recording of each
1 13 distribution of any given drug or device, from the sale by the
1 14 manufacturer through acquisition and sale by any wholesaler,
1 15 pursuant to rules adopted by the board.
1 16 Sec. 3. Section 155A.3, subsection 33, paragraph b, Code
1 17 2005, is amended to read as follows:
1 18 b. A drug or device that under federal law is required,
1 19 prior to being dispensed or delivered, to be labeled with
1 20 either one of the following statements:
1 21 (1) Caution: Federal law prohibits dispensing without a
1 22 prescription.
1 23 (2) Caution: Federal law restricts this drug to use by or
1 24 on the order of a licensed veterinarian.
1 25 (3) Caution: Federal law restricts this device to sale
1 26 by, or on the order of, a physician.
1 27 (4) Rx only.
1 28 Sec. 4. Section 155A.3, subsection 35, Code 2005, is
1 29 amended to read as follows:
1 30 35. "Proprietary medicine" or "over=the=counter medicine"
1 31 means a nonnarcotic drug or device that may be sold without a
1 32 prescription and that is labeled and packaged in compliance
1 33 with applicable state or federal law.
1 34 Sec. 5. Section 155A.3, subsection 38, Code 2005, is
1 35 amended to read as follows:
2 1 38. "Wholesaler" means a person operating or maintaining,
2 2 either within or outside this state, a manufacturing plant,
2 3 wholesale distribution center, wholesale business, or any
2 4 other business in which prescription drugs or devices,
2 5 medicinal chemicals, medicines, or poisons are sold,
2 6 manufactured, compounded, dispensed, stocked, exposed,
2 7 distributed from, or offered for sale at wholesale in this
2 8 state. "Wholesaler" does not include those wholesalers who
2 9 sell only proprietary or over=the=counter medicines.
2 10 "Wholesaler" also does not include a commercial carrier that
2 11 temporarily stores prescription drugs or devices, medicinal
2 12 chemicals, medicines, or poisons while in transit.
2 13 Sec. 6. Section 155A.4, subsection 2, paragraph a, Code
2 14 2005, is amended to read as follows:
2 15 a. A manufacturer or wholesaler to distribute prescription
2 16 drugs or devices as provided by state or federal law.
2 17 Sec. 7. Section 155A.13, subsection 6, unnumbered
2 18 paragraph 1, Code 2005, is amended to read as follows:
2 19 To qualify for a pharmacy license, the applicant shall
2 20 submit to the board a license fee as determined by the board
2 21 and a completed application on a form prescribed by the board
2 22 that shall include the following information and. The
2 23 application shall include the following and such other
2 24 information as required by rules of the board and shall be
2 25 given under oath:
2 26 Sec. 8. Section 155A.17, subsection 2, Code 2005, is
2 27 amended to read as follows:
2 28 2. The board shall establish standards for drug wholesaler
2 29 licensure and may define specific types of wholesaler
2 30 licenses. The board may deny, suspend, or revoke a drug
2 31 wholesale license for failure to meet the applicable standards
2 32 or for a violation of the laws of this state, another state,
2 33 or the United States relating to prescription drugs, devices,
2 34 or controlled substances, or for a violation of this chapter,
2 35 chapter 124, 124A, 124B, 126, or 205, or a rule of the board.
3 1 Sec. 9. Section 155A.19, subsection 1, paragraph f, Code
3 2 2005, is amended by striking the paragraph and inserting in
3 3 lieu thereof the following:
3 4 f. Change of legal name or doing=business=as name.
3 5 Sec. 10. Section 155A.19, Code 2005, is amended by adding
3 6 the following new subsection:
3 7 NEW SUBSECTION. 3. A wholesaler shall report in writing
3 8 to the board, pursuant to its rules, the following:
3 9 a. Permanent closing or discontinuation of wholesale
3 10 distributions into this state.
3 11 b. Change of ownership.
3 12 c. Change of location.
3 13 d. Change of the wholesaler's responsible individual.
3 14 e. Change of legal name or doing=business=as name.
3 15 f. Theft or significant loss of any controlled substance
3 16 on discovery of the theft or loss.
3 17 g. Disasters, accidents, and emergencies that may affect
3 18 the strength, purity, or labeling of drugs, medications,
3 19 devices, or other materials used in the diagnosis or the
3 20 treatment of injury, illness, and disease.
3 21 h. Other information or activities as required by rule.
3 22 Sec. 11. Section 155A.20, subsection 1, Code 2005, is
3 23 amended to read as follows:
3 24 1. A person, other than a pharmacy or wholesaler licensed
3 25 under this chapter, shall not display in or on any store,
3 26 internet site, or place of business, nor use in any
3 27 advertising or promotional literature, communication, or
3 28 representation, the word or words: "apothecary", "drug",
3 29 "drug store", or "pharmacy", either in English or any other
3 30 language, any other word or combination of words of the same
3 31 or similar meaning, or any graphic representation in a manner
3 32 that would mislead the public unless it is a pharmacy or drug
3 33 wholesaler licensed under this chapter.
3 34 Sec. 12. Section 155A.21, Code 2005, is amended to read as
3 35 follows:
4 1 155A.21 UNLAWFUL POSSESSION OF PRESCRIPTION DRUG OR DEVICE
4 2 == PENALTY.
4 3 1. A person found in possession of a drug or device
4 4 limited to dispensation by prescription, unless the drug or
4 5 device was so lawfully dispensed, commits a serious
4 6 misdemeanor.
4 7 2. Subsection 1 does not apply to a licensed pharmacy,
4 8 licensed wholesaler, physician, veterinarian, dentist,
4 9 podiatric physician, therapeutically certified optometrist,
4 10 advanced registered nurse practitioner, physician assistant, a
4 11 nurse acting under the direction of a physician, or the board
4 12 of pharmacy examiners, its officers, agents, inspectors, and
4 13 representatives, nor to a common carrier, manufacturer's
4 14 representative, or messenger when transporting the drug or
4 15 device in the same unbroken package in which the drug or
4 16 device was delivered to that person for transportation.
4 17 Sec. 13. Section 155A.23, Code 2005, is amended to read as
4 18 follows:
4 19 155A.23 PROHIBITED ACTS.
4 20 A person shall not perform or cause the performance of or
4 21 aid and abet any of the following acts:
4 22 1. Obtain or attempt Obtaining or attempting to obtain a
4 23 prescription drug or device or procure or attempt procuring or
4 24 attempting to procure the administration of a prescription
4 25 drug or device by:
4 26 a. Fraud Engaging in fraud, deceit, misrepresentation, or
4 27 subterfuge.
4 28 b. Forgery or alteration of Forging or altering a written,
4 29 electronic, or facsimile prescription or of any written,
4 30 electronic, or facsimile order.
4 31 c. Concealment of Concealing a material fact.
4 32 d. Use of Using a false name or the giving of a false
4 33 address.
4 34 2. Willfully make making a false statement in any
4 35 prescription, report, or record required by this chapter.
5 1 3. For the purpose of obtaining a prescription drug or
5 2 device, falsely assume assuming the title of or claim claiming
5 3 to be a manufacturer, wholesaler, pharmacist, pharmacy owner,
5 4 physician, dentist, podiatric physician, veterinarian, or
5 5 other authorized person.
5 6 4. Make or utter Making or uttering any false or forged
5 7 oral, written, electronic, or facsimile prescription or oral,
5 8 written, electronic, or facsimile order.
5 9 5. Affix any false or forged label to a package or
5 10 receptacle containing prescription drugs Forging,
5 11 counterfeiting, simulating, or falsely representing any drug
5 12 or device without the authority of the manufacturer, or using
5 13 any mark, stamp, tag, label, or other identification device
5 14 without the authorization of the manufacturer.
5 15 6. Manufacturing, repackaging, selling, delivering, or
5 16 holding or offering for sale any drug or device that is
5 17 adulterated, misbranded, counterfeit, suspected of being
5 18 counterfeit, or that has otherwise been rendered unfit for
5 19 distribution.
5 20 7. Adulterating, misbranding, or counterfeiting any drug
5 21 or device.
5 22 8. Receiving any drug or device that is adulterated,
5 23 misbranded, stolen, obtained by fraud or deceit, counterfeit,
5 24 or suspected of being counterfeit, and delivering or
5 25 proffering delivery of such drug or device for pay or
5 26 otherwise.
5 27 9. Adulterating, mutilating, destroying, obliterating, or
5 28 removing the whole or any part of the labeling of a drug or
5 29 device or committing any other act with respect to a drug or
5 30 device that results in the drug or device being misbranded.
5 31 10. Purchasing or receiving a drug or device from a person
5 32 who is not licensed to distribute the drug or device to that
5 33 purchaser or recipient.
5 34 11. Selling or transferring a drug or device to a person
5 35 who is not authorized under the law of the jurisdiction in
6 1 which the person receives the drug or device to purchase or
6 2 possess the drug or device from the person selling or
6 3 transferring the drug or device.
6 4 12. Failing to maintain or provide records as required by
6 5 this chapter, chapter 124, or rules of the board.
6 6 13. Providing the board or any of its representatives or
6 7 any state or federal official with false or fraudulent records
6 8 or making false or fraudulent statements regarding any matter
6 9 within the scope of this chapter, chapter 124, or rules of the
6 10 board.
6 11 14. Distributing at wholesale any drug or device that
6 12 meets any of the following conditions:
6 13 a. The drug or device was purchased by a public or private
6 14 hospital or other health care entity.
6 15 b. The drug or device was donated or supplied at a reduced
6 16 price to a charitable organization.
6 17 c. The drug or device was purchased from a person not
6 18 licensed to distribute the drug or device.
6 19 d. The drug or device was stolen or obtained by fraud or
6 20 deceit.
6 21 15. Failing to obtain a license or operating without a
6 22 valid license when a license is required pursuant to this
6 23 chapter or chapter 147.
6 24 16. Engaging in misrepresentation or fraud in the
6 25 distribution of a drug or device.
6 26 17. Distributing a drug or device to a patient without a
6 27 prescription drug order or medication order from a
6 28 practitioner licensed by law to use or prescribe the drug or
6 29 device.
6 30 18. Distributing a drug or device that was previously
6 31 dispensed by a pharmacy or distributed by a practitioner
6 32 except as provided by rules of the board.
6 33 19. Failing to report any prohibited act.
6 34 Information communicated to a physician in an unlawful
6 35 effort to procure a prescription drug or device or to procure
7 1 the administration of a prescription drug shall not be deemed
7 2 a privileged communication.
7 3 Subsections 6 and 7 shall not apply to the wholesale
7 4 distribution by a manufacturer of a prescription drug or
7 5 device that has been delivered into commerce pursuant to an
7 6 application approved by the federal food and drug
7 7 administration.
7 8 Sec. 14. Section 155A.24, Code 2005, is amended to read as
7 9 follows:
7 10 155A.24 PENALTIES.
7 11 1. A Except as otherwise provided in this section, a
7 12 person who violates a provision of section 155A.23 or who
7 13 sells or offers for sale, gives away, or administers to
7 14 another person any prescription drug or device in violation of
7 15 this chapter commits a public offense and shall be punished as
7 16 follows:
7 17 a. If the prescription drug is a controlled substance, the
7 18 person shall be punished pursuant to section 124.401,
7 19 subsection 1, and section 124.411 chapter 124, division IV.
7 20 b. If the prescription drug is not a controlled substance,
7 21 the person, upon conviction of a first offense, is guilty of a
7 22 serious misdemeanor. For a second offense, or if in case of a
7 23 first offense the offender previously has been convicted of
7 24 any violation of the laws of the United States or of any
7 25 state, territory, or district thereof relating to prescription
7 26 drugs or devices, the offender is guilty of an aggravated
7 27 misdemeanor. For a third or subsequent offense or if in the
7 28 case of a second offense the offender previously has been
7 29 convicted two or more times in the aggregate of any violation
7 30 of the laws of the United States or of any state, territory,
7 31 or district thereof relating to prescription drugs or devices,
7 32 the offender is guilty of a class "D" felony.
7 33 2. A person who violates any provision of this chapter by
7 34 selling, giving away, or administering any prescription drug
7 35 or device to a minor is guilty of a class "C" felony.
8 1 3. A wholesaler who, with intent to defraud or deceive,
8 2 fails to deliver to another person, when required by rules of
8 3 the board, complete and accurate pedigree concerning a drug
8 4 prior to transferring the drug to another person is guilty of
8 5 a class "C" felony.
8 6 4. A wholesaler who, with intent to defraud or deceive,
8 7 fails to acquire, when required by rules of the board,
8 8 complete and accurate pedigree concerning a drug prior to
8 9 obtaining the drug from another person is guilty of a class
8 10 "C" felony.
8 11 5. A wholesaler who knowingly destroys, alters, conceals,
8 12 or fails to maintain, as required by rules of the board,
8 13 complete and accurate pedigree concerning any drug in the
8 14 person's possession is guilty of a class "C" felony.
8 15 6. A wholesaler who is in possession of pedigree documents
8 16 required by rules of the board, and who knowingly fails to
8 17 authenticate the matters contained in the documents as
8 18 required, and who nevertheless distributes or attempts to
8 19 further distribute drugs is guilty of a class "C" felony.
8 20 7. A wholesaler who, with intent to defraud or deceive,
8 21 falsely swears or certifies that the person has authenticated
8 22 any documents related to the wholesale distribution of drugs
8 23 or devices is guilty of a class "C" felony.
8 24 8. A wholesaler who knowingly forges, counterfeits, or
8 25 falsely creates any pedigree, who falsely represents any
8 26 factual matter contained in any pedigree, or who knowingly
8 27 omits to record material information required to be recorded
8 28 in a pedigree is guilty of a class "C" felony.
8 29 9. A wholesaler who knowingly purchases or receives drugs
8 30 or devices from a person not authorized to distribute drugs or
8 31 devices in wholesale distribution is guilty of a class "C"
8 32 felony.
8 33 10. A wholesaler who knowingly sells, barters, brokers, or
8 34 transfers a drug or device to a person not authorized to
8 35 purchase the drug or device under the jurisdiction in which
9 1 the person receives the drug or device in a wholesale
9 2 distribution is guilty of a class "C" felony.
9 3 11. A person who knowingly possesses, actually or
9 4 constructively, any amount of a counterfeit, misbranded, or
9 5 adulterated drug or device and who knowingly sells or delivers
9 6 any amount of the counterfeit, misbranded, or adulterated drug
9 7 or device or who possesses with intent to sell or deliver any
9 8 amount of a counterfeit, misbranded, or adulterated drug or
9 9 device is guilty of a class "C" felony.
9 10 12. A person who knowingly forges, counterfeits, or
9 11 falsely creates any label for a drug or device or who falsely
9 12 represents any factual matter contained on any label of a drug
9 13 or device is guilty of a class "C" felony.
9 14 13. A person who knowingly possesses, actually or
9 15 constructively, any amount of a counterfeit, misbranded, or
9 16 adulterated drug or device and who knowingly manufactures,
9 17 purchases, sells, delivers, or brings into the state any
9 18 amount of the counterfeit, misbranded, or adulterated drug or
9 19 device, is guilty of a class "D" felony.
9 20 14. A person who knowingly manufactures, purchases, sells,
9 21 delivers, or brings into the state, or who is knowingly in
9 22 actual or constructive possession of any amount of a
9 23 counterfeit, misbranded, or adulterated drug or device, and
9 24 whose acts result in the death of a person is guilty of a
9 25 class "A" felony.
9 26 15. A person found guilty of any offense under this
9 27 section or under chapter 124, division IV, under the authority
9 28 of the court convicting and sentencing the person, shall order
9 29 that the person forfeit to the state, pursuant to chapter
9 30 809A, any real or personal property that meets either of the
9 31 following conditions:
9 32 a. The property was used or intended to be used to commit,
9 33 facilitate, or promote the commission of such offense.
9 34 b. The property constitutes, derives from, or is traceable
9 35 to the gross proceeds that the defendant obtained directly or
10 1 indirectly as a result of the offense.
10 2 Any property or assets subject to forfeiture under this
10 3 subsection may be seized in the manner prescribed in chapter
10 4 809A, and may be held as provided in that chapter. Moneys
10 5 ordered forfeited, or proceeds from the sale of other assets
10 6 ordered forfeited, shall be equitably divided among the board
10 7 and other agencies involved in the investigation and
10 8 prosecution that led to the conviction. Other property
10 9 ordered forfeited after conviction of a defendant may, at the
10 10 discretion of the investigating agencies, be placed into
10 11 official use by the board or the agencies involved in the
10 12 investigation and prosecution that led to the conviction.
10 13 16. This section does not prevent a licensed practitioner
10 14 of medicine, dentistry, podiatry, nursing, veterinary
10 15 medicine, optometry, or pharmacy from acts necessary in the
10 16 ethical and legal performance of the practitioner's
10 17 profession.
10 18 Sec. 15. NEW SECTION. 155A.40 CRIMINAL HISTORY RECORD
10 19 CHECKS.
10 20 1. The board may request and obtain, notwithstanding
10 21 section 692.2, subsection 5, criminal history data for any
10 22 applicant for an initial or renewal license or registration
10 23 issued pursuant to this chapter or chapter 147, any applicant
10 24 for reinstatement of a license or registration issued pursuant
10 25 to this chapter or chapter 147, or any licensee or registrant
10 26 who is being monitored as a result of a board order or
10 27 agreement resolving an administrative disciplinary action, for
10 28 the purpose of evaluating the applicant's, licensee's, or
10 29 registrant's eligibility for licensure, registration, or
10 30 suitability for continued practice of the profession.
10 31 Criminal history data may be requested for of all owners,
10 32 managers, and principal employees of a pharmacy or drug
10 33 wholesaler licensed pursuant to this chapter. The board shall
10 34 adopt rules pursuant to chapter 17A to implement this section.
10 35 The board shall inform the applicant, licensee, or registrant
11 1 of the criminal history requirement and obtain a signed waiver
11 2 from the applicant, licensee, or registrant prior to
11 3 submitting a criminal history data request.
11 4 2. A request for criminal history data shall be submitted
11 5 to the department of public safety, division of criminal
11 6 investigation and bureau of identification, pursuant to
11 7 section 692.2, subsection 1. The board may also require such
11 8 applicants, licensees, and registrants to provide a full set
11 9 of fingerprints, in a form and manner prescribed by the board.
11 10 Such fingerprints may be submitted to the federal bureau of
11 11 investigation through the state criminal history repository
11 12 for a national criminal history check. The board may
11 13 authorize alternate methods or sources for obtaining criminal
11 14 history record information. The board may, in addition to any
11 15 other fees, charge and collect such amounts as may be incurred
11 16 by the board, the department of public safety, or the federal
11 17 bureau of investigation in obtaining criminal history
11 18 information. Amounts collected shall be considered repayment
11 19 receipts as defined in section 8.2.
11 20 3. Criminal history information relating to an applicant,
11 21 licensee, or registrant obtained by the board pursuant to this
11 22 section is confidential. The board may, however, use such
11 23 information in a license or registration denial proceeding.
11 24 In a disciplinary proceeding, such information shall
11 25 constitute investigative information under section 272C.6,
11 26 subsection 4, and may be used only for purposes consistent
11 27 with that section.
11 28 4. This section shall not apply to a manufacturer of a
11 29 prescription drug or device that has been delivered into
11 30 commerce pursuant to an application approved by the federal
11 31 food and drug administration.
11 32 Sec. 16. NEW SECTION. 155A.41 CONTINUOUS QUALITY
11 33 IMPROVEMENT PROGRAM.
11 34 1. Each licensed pharmacy shall implement or participate
11 35 in a continuous quality improvement program to review pharmacy
12 1 procedures in order to identify methods for addressing
12 2 pharmacy medication errors and for improving patient use of
12 3 medications and patient care services. Under the program,
12 4 each pharmacy shall assess its practices and identify areas
12 5 for quality improvement.
12 6 2. The board shall adopt rules for the administration of a
12 7 continuous quality improvement program. The rules shall
12 8 address all of the following:
12 9 a. Program requirements and procedures.
12 10 b. Program record and reporting requirements.
12 11 c. Any other provisions necessary for the administration
12 12 of a program.
12 13 EXPLANATION
12 14 This bill makes several technical and substantive changes
12 15 regarding Code chapter 155A relating to the practice of
12 16 pharmacy.
12 17 The bill makes changes to definitions applicable to the
12 18 Code chapter. The bill expands the definition of "dispense"
12 19 to include the delivery of a device, and makes several other
12 20 conforming changes in the Code chapter adding a reference to
12 21 "device" where a prescription drug is referred to. The bill
12 22 also provides a new definition of "pedigree" to mean a
12 23 recording of each distribution of any given drug or device,
12 24 from the sale by the manufacturer through acquisition and sale
12 25 by any wholesaler, pursuant to rules adopted by the board of
12 26 pharmacy examiners. The bill adds "over=the=counter medicine"
12 27 as an alternative term to "proprietary medicine" with
12 28 reference to a nonnarcotic drug or device that may be sold
12 29 without a prescription, and adds two new labeling statements
12 30 required under federal law prior to dispensation or delivery.
12 31 With reference to the definition of a "wholesaler", the bill
12 32 provides that a wholesaler does not include a commercial
12 33 carrier that temporarily stores prescription drugs or devices,
12 34 medicinal chemicals, medicines, or poisons while in transit.
12 35 The bill provides that the application form submitted by an
13 1 applicant for a pharmacy license shall include information
13 2 specified in the statute, and other information that may be
13 3 required by the board by rule, and that the board may define
13 4 specific types of wholesaler licenses.
13 5 The bill provides that a drug wholesaler shall report in
13 6 writing to the board information relating to the permanent
13 7 closing or discontinuation of wholesale distributions into the
13 8 state, a change of ownership or location, a change concerning
13 9 the individual designated as the wholesaler's responsible
13 10 individual, a change of name, the theft or significant loss of
13 11 any controlled substance on discovery of the theft or loss,
13 12 any disasters, accidents, and emergencies that may affect the
13 13 strength, purity, or labeling of drugs, medications, devices,
13 14 or other materials used in the diagnosis or the treatment of
13 15 injury, illness, and disease, and other information or
13 16 activities as required by rules of the board.
13 17 The bill extends prohibitions against the use of the word
13 18 "apothecary", "drug", "drug store", or "pharmacy" by
13 19 individuals other than licensed pharmacists or wholesalers, to
13 20 internet sites, and to any advertising or promotional
13 21 literature, communication, or representation.
13 22 The bill adds a number of new provisions regarding acts
13 23 which are unlawful for a person to perform, or cause the
13 24 performance of, or aid and abet, and therefore prohibited.
13 25 The bill provides that a person shall not engage in forging,
13 26 counterfeiting, simulating, or falsely representing any drug
13 27 or device without the authority of the manufacturer, or using
13 28 any mark, stamp, tag, label, or other identification device
13 29 without manufacturer authorization; or engage in
13 30 manufacturing, repackaging, selling, delivering, or holding or
13 31 offering for sale any drug or device that is adulterated,
13 32 misbranded, counterfeit, suspected of being counterfeit, or
13 33 that has otherwise been rendered unfit for distribution; or
13 34 engage in adulterating, misbranding, or counterfeiting any
13 35 drug or device; or receive any drug or device that is
14 1 adulterated, misbranded, stolen, obtained by fraud or deceit,
14 2 counterfeit, or suspected of being counterfeit; or deliver or
14 3 proffer delivery of such drug or device for pay or otherwise.
14 4 The bill provides that prohibitions relating to manufacturing,
14 5 repackaging, selling, delivering, or holding or offering for
14 6 sale any drug or device that is adulterated, misbranded,
14 7 counterfeit, suspected of being counterfeit, or that has
14 8 otherwise been rendered unfit for distribution, and to
14 9 adulterating, misbranding, or counterfeiting any drug or
14 10 device, shall not be applicable to the wholesale distribution
14 11 by a manufacturer of a prescription drug or device that has
14 12 been delivered into commerce pursuant to an application
14 13 approved by the federal food and drug administration, whose
14 14 own regulations shall apply in such instances. Further, the
14 15 bill provides that a person shall not engage in adulterating,
14 16 mutilating, destroying, obliterating, or removing the whole or
14 17 any part of the labeling of a drug or device or committing any
14 18 other act with respect to a drug or device that results in the
14 19 drug or device being misbranded; or engage in purchasing or
14 20 receiving a drug or device from a person that is not licensed
14 21 to distribute the drug or device to that purchaser or
14 22 recipient; or engage in selling or transferring a drug or
14 23 device to a person that is not authorized under the law of the
14 24 jurisdiction in which the person receives the drug or device
14 25 to purchase or possess it; or fail to maintain or provide
14 26 required records.
14 27 Additional prohibited acts include providing the board or
14 28 any of its representatives or any state or federal official
14 29 with false or fraudulent records or making false or fraudulent
14 30 statements; distributing at wholesale any drug or device that
14 31 was purchased by a public or private hospital or other health
14 32 care entity, donated or supplied at a reduced price to a
14 33 charitable organization, purchased from a person not licensed
14 34 to distribute it, or stolen or obtained by fraud or deceit;
14 35 failing to obtain a required license or operating without a
15 1 valid license; and engaging in misrepresentation or fraud in
15 2 the distribution of a drug or device.
15 3 Finally, prohibited acts also include distributing a drug
15 4 or device to a patient without a prescription drug order or
15 5 medication order from a practitioner licensed by law to use or
15 6 prescribe the drug or device; distributing a drug or device
15 7 that was previously dispensed by a pharmacy or distributed by
15 8 a practitioner except as provided by rule; and failing to
15 9 report any prohibited act.
15 10 The bill also expands the list of penalties contained in
15 11 Code section 155A.24. The bill provides that a wholesaler
15 12 shall be guilty of a class "C" felony if the wholesaler, with
15 13 intent to defraud or deceive, fails to deliver to another
15 14 person, when required by rules of the board, complete and
15 15 accurate pedigree concerning a drug prior to transferring the
15 16 drug to another person; or with intent to defraud or deceive,
15 17 fails to acquire, when required by rules of the board,
15 18 complete and accurate pedigree concerning a drug prior to
15 19 obtaining the drug from another person; or who knowingly
15 20 destroys, alters, conceals, or fails to maintain, as required
15 21 by rules of the board, complete and accurate pedigree
15 22 concerning any drug in the person's possession; or who is in
15 23 possession of pedigree documents required by rules of the
15 24 board, and who knowingly fails to authenticate the matters
15 25 contained in the documents as required, and who nevertheless
15 26 distributes or attempts to further distribute drugs; or with
15 27 intent to defraud or deceive, falsely swears or certifies that
15 28 the person has authenticated any documents related to the
15 29 wholesale distribution of drugs or devices. Additionally, the
15 30 bill provides that a wholesaler shall be guilty of a class "C"
15 31 felony if the wholesaler knowingly forges, counterfeits, or
15 32 falsely creates any pedigree, who falsely represents any
15 33 factual matter contained in any pedigree, or who knowingly
15 34 omits to record material information required to be recorded
15 35 in a pedigree; or knowingly purchases or receives drugs or
16 1 devices from a person not authorized to distribute drugs or
16 2 devices in wholesale distribution; or knowingly sells,
16 3 barters, brokers, or transfers a drug or device to a person
16 4 not authorized to purchase the drug or device under the
16 5 jurisdiction in which the person receives the drug or device
16 6 in a wholesale distribution.
16 7 The bill provides, in addition, that a person who knowingly
16 8 possesses, actually or constructively, any amount of a
16 9 counterfeit, misbranded, or adulterated drug or device and who
16 10 knowingly sells or delivers any amount of the counterfeit,
16 11 misbranded, or adulterated drug or device or who possesses
16 12 with intent to sell or deliver any amount of a counterfeit,
16 13 misbranded, or adulterated drug or device, shall be guilty of
16 14 a class "C" felony, as is a person who knowingly forges,
16 15 counterfeits, or falsely creates any label for a drug or
16 16 device or who falsely represents any factual matter contained
16 17 in any label of a drug or device. The bill provides that a
16 18 person who knowingly possesses, actually or constructively,
16 19 any amount of a counterfeit, misbranded, or adulterated drug
16 20 or device and who knowingly manufactures, purchases, sells,
16 21 delivers, or brings into the state any amount of the
16 22 counterfeit, misbranded, or adulterated drug or device, is
16 23 guilty of a class "D" felony. Further, a person who knowingly
16 24 manufactures, purchases, sells, delivers, or brings into the
16 25 state, or who is knowingly in actual or constructive
16 26 possession of any amount of a counterfeit, misbranded, or
16 27 adulterated drug or device, and whose acts result in the death
16 28 of a person, shall be guilty of a class "A" felony.
16 29 The bill provides for the forfeiture to and seizure by the
16 30 state of any real or personal property of a person found
16 31 guilty.
16 32 The bill authorizes the board to request criminal history
16 33 data for applicants, licensees, and registrants under Code
16 34 chapter 147 or 155A, for the purpose of evaluating the
16 35 person's eligibility for the license or registration or to
17 1 evaluate the person's suitability for the practice of the
17 2 profession. The bill provides that such requests shall not be
17 3 applicable to a manufacturer of a prescription drug or device
17 4 that has been delivered into commerce pursuant to an
17 5 application approved by the federal food and drug
17 6 administration, whose own regulations shall apply in such
17 7 instances.
17 8 The bill requires each licensed pharmacy to implement a
17 9 continuous quality improvement program to review pharmacy
17 10 procedures in order to identify methods for addressing
17 11 pharmacy medication errors and for improving patient use of
17 12 medications and patient care services. The bill provides that
17 13 the board shall adopt rules for the administration of the
17 14 program.
17 15 LSB 1292HZ 81
17 16 rn:nh/pj/5