Iowa General Assembly Daily Bills, Amendments & Study Bills March 17, 2009

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141 24 prescribed, recommended, or suggested in its labeling.

141 25 11. k. If it is, or purports to be, or is represented as

141 26 a drug composed wholly or partly of insulin, unless both of

141 27 the following apply:

141 28 a. (1) It is from a batch with respect to which a

141 29 certificate or release has been issued pursuant to section 506

141 30 of the federal Act.

141 31 b. (2) The certificate or release is in effect with

141 32 respect to the drug.

141 33 12. l. (1) If it is, or purports to be, or is

141 34 represented as a drug, composed wholly or partly of any kind

141 35 of penicillin, streptomycin, chlortetracycline,


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142 1 chloramphenicol, bacitracin, or any other antibiotic drug, or

142 2 any derivative thereof, unless both of the following apply:

142 3 a. (a) It is from a batch with respect to which a

142 4 certificate or release has been issued pursuant to section 507

142 5 of the federal Act.

142 6 b. (b) The certificate or release is in effect with

142 7 respect to the drug.

142 8 (2) However, this subsection paragraph "l" does not apply

142 9 to any drug or class of drugs exempted by regulations adopted

142 10 under section 507(c) or 507(d) of the federal Act.

142 11 13. m. If it is a color additive, the intended use of

142 12 which is for the purpose of coloring only, unless its

142 13 packaging and labeling are in conformity with the packaging

142 14 and labeling requirements applicable to that color additive,

142 15 as contained in regulations adopted under section 706 of the

142 16 federal Act.

142 17 14. n. If it is a prescription drug distributed or

142 18 offered for sale in this state, unless the manufacturer,

142 19 packer, or distributor includes in all advertising and other

142 20 descriptive printed matter issued or caused to be issued by

142 21 the manufacturer, packer, or distributor with respect to the

142 22 prescription drug a true statement of all of the following:

142 23 a. (1) The established name as defined in subsection 5

142 24 paragraph "e", printed prominently and in type at least half

142 25 as large as that used for any trade or brand name thereof.

142 26 b. (2) The formula showing quantitatively each ingredient

142 27 of the prescription drug to the extent required for labels

142 28 under subsection 5 paragraph "e".

142 29 c. (3) Other information in brief summary relating to

142 30 side effects, contraindications, and effectiveness as required

142 31 in regulations adopted pursuant to section 701(e) of the

142 32 federal Act.

142 33 15. o. If it was manufactured, prepared, propagated,

142 34 compounded, or processed in an establishment in this state not

142 35 duly registered under section 510 of the federal Act, if it
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143 1 was not included on a list required by section 510(j) of the

143 2 federal Act, if a notice or other information respecting it

143 3 was not provided as required by that section or section 510(k)

143 4 of the federal Act, or if it does not bear the symbols from

143 5 the uniform system for identification of devices prescribed

143 6 under section 510(e) of the federal Act that are required by

143 7 regulation.

143 8 16. p. If it is a drug and its packaging or labeling is

143 9 in violation of an applicable regulation adopted pursuant to

143 10 section 3 or 4 of the federal Poison Prevention Packaging Act

143 11 of 1970, 15 U.S.C. } 1471 et seq.

143 12 17. q. If a trademark, trade name, or other identifying

143 13 mark, imprint, or device of another trademark, trade name,

143 14 mark, or imprint or any likeness of the foregoing has been

143 15 placed thereon or upon its container with intent to defraud.

143 16 18. r. In the case of a restricted device distributed or

143 17 offered for sale in this state, if either of the following

143 18 applies:

143 19 a. (1) Its advertising is false or misleading in any

143 20 particular.

143 21 b. (2) It is sold, distributed, or used in violation of

143 22 regulations adopted pursuant to section 520(e) of the federal

143 23 Act.

143 24 19. s. In the case of a restricted device distributed or

143 25 offered for sale in this state, unless the manufacturer,

143 26 packer, or distributor includes in all advertising and other

143 27 descriptive printed matter issued by the manufacturer, packer,

143 28 or distributor with respect to the device both of the

143 29 following:

143 30 a. (1) A true statement of the device's established name

143 31 as defined in subsection 5 paragraph "e", printed prominently

143 32 and in type at least half as large as that used for any trade

143 33 or brand name thereof.

143 34 b. (2) A brief statement of the intended uses of the

143 35 device and relevant warnings, precautions, side effects, and
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144 1 contraindications; and in the case of a specific device made

144 2 subject to regulations adopted pursuant to the federal Act, a

144 3 full description of the components of the device or the

144 4 formula showing quantitatively each ingredient of the device

144 5 to the extent required in regulations under the federal Act.

144 6 20. t. If it is a device subject to a performance

144 7 standard established under section 514 of the federal Act,

144 8 unless it bears labeling as prescribed in that performance

144 9 standard.

144 10 21. u. If it is a device and there was a failure or

144 11 refusal to comply with any requirement prescribed under

144 12 section 518 of the federal Act respecting the device, or to

144 13 furnish material required by or under section 519 of the

144 14 federal Act respecting the device.

144 15 2. If an article is alleged to be misbranded because the

144 16 labeling or advertising is misleading, then in determining

144 17 whether the labeling or advertising is misleading, there shall

144 18 be taken into account, among other things, not only

144 19 representations made or suggested by statement, word, design,

144 20 device, or any combination thereof, but also the extent to

144 21 which the labeling or advertising fails to reveal facts

144 22 material in the light of such representations, or material

144 23 with respect to consequences which may result from the use of

144 24 the article to which the labeling or advertising relates,

144 25 under the conditions of use prescribed in the labeling or

144 26 advertising or under customary or usual conditions of use.

144 27 3. The representation of a drug, in its labeling, as an

144 28 antiseptic shall be considered to be a representation that it

144 29 is a germicide, except in the case of a drug purporting to be,

144 30 or represented as, an antiseptic for inhibitory use as a wet

144 31 dressing, ointment, dusting powder, or such other use as

144 32 involves prolonged contact with the body.

144 33 Sec. 190. Section 126.11, subsection 3, paragraphs a

144 34 through c, Code 2009, are amended to read as follows:

144 35 a. (1) This lettered paragraph "a" applies to a drug
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145 1 intended for use by humans which is any of the following:

145 2 (1) (a) Is a habit=forming drug to which section 126.10,

145 3 subsection 4 1, paragraph "d" applies.

145 4 (2) (b) Because of its toxicity or other potentiality for

145 5 harmful effect, or the method of its use, or the collateral

145 6 measures necessary to its use, is not safe for use except

145 7 under the supervision of a practitioner licensed by law to

145 8 administer the drug.

145 9 (3) (c) Is limited by an approved application under

145 10 section 505 of the federal Act to use under the professional

145 11 supervision of a practitioner licensed by law to administer

145 12 the drug.

145 13 (2) Such a drug shall be dispensed only upon a written,

145 14 electronic, or facsimile prescription of a practitioner

145 15 licensed by law to administer the drug, or upon an oral

145 16 prescription of such a practitioner which is reduced promptly

145 17 to writing and filed by the pharmacist, or by refilling any

145 18 such written, electronic, facsimile, or oral prescription if

145 19 the refilling is authorized by the prescriber either in the

145 20 original written, electronic, or facsimile prescription or by

145 21 oral order which is reduced promptly to writing and filed by

145 22 the pharmacist. The act of dispensing a drug contrary to this

145 23 paragraph "a" while the drug is held for sale results in the

145 24 drug being misbranded.

145 25 b. A drug dispensed by filling or refilling a written,

145 26 electronic, facsimile, or oral prescription of a practitioner

145 27 licensed by law to administer the drug is exempt from section

145 28 126.10, except subsection 1, subsection 9, paragraphs "b" and


145 29 "c" paragraph "a" and paragraph "i", subparagraphs (2) and

145 30 (3), and subsections 11 subsection 1, paragraphs "k" and 12

145 31 "l", and the packaging requirements of subsections 7, 8,

145 32 subsection 1, paragraphs "g", "h", and 16 "p", if the drug

145 33 bears a label containing the name and address of the

145 34 dispenser, the date of the prescription or of its filling, the

145 35 name of the prescriber, and, if stated in the prescription,


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146 1 the name of the patient, and the directions for use and

146 2 cautionary statements, if any, contained in the prescription.

146 3 This exemption does not apply to a drug dispensed in the

146 4 course of the conduct of the business of dispensing drugs

146 5 pursuant to diagnosis by mail, or to a drug dispensed in

146 6 violation of paragraph "a" of this subsection.

146 7 c. The board may, by rule, remove a drug subject to

146 8 section 126.10, subsection 4 1, paragraph "d", and section 505

146 9 of the federal Act from the requirements of paragraph "a" of

146 10 this subsection when such requirements are not necessary for

146 11 the protection of the public health.

146 12 Sec. 191. Section 135.67, Code 2009, is amended to read as

146 13 follows:

146 14 135.67 SUMMARY REVIEW PROCEDURE.

146 15 1. The department may waive the letter of intent

146 16 procedures prescribed by section 135.65 and substitute a

146 17 summary review procedure, which shall be established by rules

146 18 of the department, when it accepts an application for a

146 19 certificate of need for a project which meets any of the

146 20 criteria in subsections 1 paragraphs "a" through 5 "e":

146 21 1. a. A project which is limited to repair or replacement

146 22 of a facility or equipment damaged or destroyed by a disaster,

146 23 and which will not expand the facility nor increase the

146 24 services provided beyond the level existing prior to the

146 25 disaster.

146 26 2. b. A project necessary to enable the facility or

146 27 service to achieve or maintain compliance with federal, state

146 28 or other appropriate licensing, certification or safety

146 29 requirements.

146 30 3. c. A project which will not change the existing bed

146 31 capacity of the applicant's facility or service, as determined

146 32 by the department, by more than ten percent or ten beds,

146 33 whichever is less, over a two=year period.

146 34 4. d. A project the total cost of which will not exceed

146 35 one hundred fifty thousand dollars.
Senate File 446 - Introduced continued
147 1 5. e. Any other project for which the applicant proposes

147 2 and the department agrees to summary review.

147 3 2. The department's decision to disallow a summary review

147 4 shall be binding upon the applicant.

147 5 Sec. 192. Section 135B.33, Code 2009, is amended to read

147 6 as follows:

147 7 135B.33 TECHNICAL ASSISTANCE == PLAN == GRANTS.

147 8 1. Subject to availability of funds, the Iowa department

147 9 of public health shall provide technical planning assistance

147 10 to local boards of health and hospital governing boards to

147 11 ensure access to hospital services in rural areas. The

147 12 department shall encourage the local boards of health and

147 13 hospital governing boards to adopt a long=term community

147 14 health services and developmental plan including the

147 15 following:

147 16 1. a. An analysis of demographic trends in the health

147 17 facility services area, affecting health facility and

147 18 health=facility=related health care utilizations.

147 19 2. b. A review of inpatient services currently provided,

147 20 by type of service and the frequency of provision of that

147 21 service, and the cost=effectiveness of that service.

147 22 3. c. An analysis of resources available in proximate

147 23 health facilities and services that might be provided through

147 24 alternative arrangements with such health facilities.

147 25 4. d. An analysis of cooperative arrangements that could

147 26 be developed with other health facilities in the area that

147 27 could assist those health facilities in the provision of

147 28 services.

147 29 5. e. An analysis of community health needs, including

147 30 long=term care, nursing facility care, pediatric and maternity

147 31 services, and the health facilities' potential role in

147 32 facilitating the provision of services to meet these needs.

147 33 6. f. An analysis of alternative uses for existing health

147 34 facility space and real property, including use for community

147 35 health=related and human service=related purposes.
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148 1 7. g. An analysis of mechanisms to meet indigent patient

148 2 care needs and the responsibilities for the care of indigent

148 3 patients.

148 4 8. h. An analysis of the existing tax levying of the

148 5 health facilities for patient care, on a per capita basis and

148 6 per hospital patient basis, and projections on future needs

148 7 for tax levying to continue for the provision of care.

148 8 2. Providers may cooperatively coordinate to develop one

148 9 long=term community health services and developmental plan for

148 10 a geographic area, provided the plan addresses the issues

148 11 enumerated in this section.

148 12 3. The health facilities may seek technical assistance or

148 13 apply for matching grant funds for the plan development. The

148 14 department shall require compliance with subsections

148 15 subsection 1, paragraphs "a" through 8 "h" when the facility

148 16 applies for matching grant funds.

148 17 Sec. 193. Section 144.17, Code 2009, is amended to read as

148 18 follows:

148 19 144.17 PETITION TO ESTABLISH CERTIFICATE.

148 20 1. If a delayed certificate of birth is rejected under the

148 21 provisions of section 144.15, a petition may be filed with the

148 22 district court for an order establishing a record of the date

148 23 and place of the birth and the parentage of the person whose

148 24 birth is to be registered.

148 25 2. a. The petition shall be made on a form prescribed and

148 26 furnished by the state registrar and shall allege:

148 27 1. (1) That the person for whom a delayed certificate of

148 28 birth is sought was born in this state.

148 29 2. (2) That no record of birth of that person can be

148 30 found in the office of the state or county custodian of birth

148 31 records.

148 32 3. (3) That diligent efforts by the petitioner have

148 33 failed to obtain the evidence required in accordance with

148 34 section 144.15.

148 35 4. (4) That the state registrar has refused to register a
Senate File 446 - Introduced continued
149 1 delayed certificate of birth.

149 2 5. (5) Such other allegations as may be required.

149 3 b. The petition shall be accompanied by a statement of the

149 4 registration official made in accordance with section 144.15

149 5 and all documentary evidence which was submitted to the

149 6 registration official in support of such registration. The

149 7 petition shall be verified by the petitioner.

149 8 Sec. 194. Section 144.43, Code 2009, is amended to read as

149 9 follows:

149 10 144.43 VITAL RECORDS CLOSED TO INSPECTION == EXCEPTIONS.

149 11 1. To protect the integrity of vital statistics records,

149 12 to ensure their proper use, and to ensure the efficient and

149 13 proper administration of the vital statistics system kept by

149 14 the state registrar, access to vital statistics records kept

149 15 by the state registrar shall be limited to the state registrar

149 16 and the state registrar's employees, and then only for

149 17 administrative purposes.

149 18 2. a. It shall be unlawful for the state registrar to

149 19 permit inspection of, or to disclose information contained in

149 20 vital statistics records, or to copy or permit to be copied

149 21 all or part of any such record except as authorized by

149 22 regulation.

149 23 b. However, the following vital statistics records may be

149 24 inspected and copied as of right under chapter 22 when they

149 25 are in the custody of a county registrar or when they are in

149 26 the custody of the state archivist and are at least

149 27 seventy=five years old:

149 28 1. (1) A record of birth.

149 29 2. (2) A record of marriage.

149 30 3. (3) A record of divorce, dissolution of marriage, or

149 31 annulment of marriage.

149 32 4. (4) A record of death if that death was not a fetal

149 33 death.

149 34 3. A public record shall not be withheld from the public

149 35 because it is combined with data processing software. The
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150 1 state registrar shall not implement any electronic data

150 2 processing system for the storage, manipulation, or retrieval

150 3 of vital records that would impair a county registrar's

150 4 ability to permit the examination of a public record and the

150 5 copying of a public record, as established by rule. If it is

150 6 necessary to separate a public record from data processing

150 7 software in order to permit the examination of the public

150 8 record, the county registrar shall periodically generate a

150 9 written log available for public inspection which contains the

150 10 public record.

150 11 Sec. 195. Section 155A.13, subsection 4, Code 2009, is

150 12 amended to read as follows:

150 13 4. a. The board shall adopt rules for the issuance of a

150 14 hospital pharmacy license to a hospital which provides

150 15 pharmacy services for its own use. The rules shall:

150 16 a. (1) Recognize the special needs and circumstances of

150 17 hospital pharmacies.

150 18 b. (2) Give due consideration to the scope of pharmacy

150 19 services that the hospital's medical staff and governing board

150 20 elect to provide for the hospital's own use.

150 21 c. (3) Consider the size, location, personnel, and

150 22 financial needs of the hospital.

150 23 d. (4) Give recognition to the standards of the joint

150 24 commission on the accreditation of health care organizations

150 25 and the American osteopathic association and to the conditions

150 26 of participation under Medicare.

150 27 b. To the maximum extent possible, the board shall

150 28 coordinate the rules with the standards and conditions

150 29 described in paragraph "d" "a", subparagraph (4), and shall

150 30 coordinate its inspections of hospital pharmacies with the

150 31 Medicare surveys of the department of inspections and appeals

150 32 and with the board's inspections with respect to controlled

150 33 substances conducted under contract with the federal

150 34 government.

150 35 c. A hospital which provides pharmacy services by
Senate File 446 - Introduced continued
151 1 contracting with a licensed pharmacy is not required to obtain

151 2 a hospital pharmacy license or a general pharmacy license.

151 3 Sec. 196. Section 155A.23, Code 2009, is amended to read

151 4 as follows:

151 5 155A.23 PROHIBITED ACTS.

151 6 1. A person shall not perform or cause the performance of

151 7 or aid and abet any of the following acts:

151 8 1. a. Obtaining or attempting to obtain a prescription

151 9 drug or device or procuring or attempting to procure the

151 10 administration of a prescription drug or device by:

151 11 a. (1) Engaging in fraud, deceit, misrepresentation, or




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