House File 515 - Introduced
HOUSE FILE
BY HUNTER
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act relating to drugs and vaccines containing mercury and
2 providing a penalty and an effective date.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
4 TLSB 2297HH 82
5 nh/gg/14
PAG LIN
1 1 Section 1. NEW SECTION. 135.39D DRUG AND VACCINE MERCURY
1 2 CONTENT TESTING == REPORTING.
1 3 The department shall randomly test drugs and vaccines
1 4 administered in this state to determine the amount of mercury
1 5 contained in the drug or vaccine. The department shall
1 6 semiannually publish a report of its findings by product name,
1 7 manufacturer, lot number, lot expiration date, and in
1 8 micrograms of mercury per milliliter or gram of drug or
1 9 vaccine. The report shall be posted on the department's
1 10 internet website.
1 11 Sec. 2. NEW SECTION. 135.39E ADMINISTRATION OF DRUGS AND
1 12 VACCINES CONTAINING MERCURY == PENALTY == CIVIL ACTION.
1 13 1. For purposes of this section:
1 14 a. (1) "Drug" means all of the following:
1 15 (a) Substances recognized as drugs in the official United
1 16 States pharmacopoeia, official homeopathic pharmacopoeia of
1 17 the United States, or official national formulary, or any
1 18 supplement to any of them.
1 19 (b) Substances intended for use in the diagnosis, cure,
1 20 mitigation, treatment, or prevention of disease in humans.
1 21 (c) Substances, other than food, intended to affect the
1 22 structure or any function of the human body.
1 23 (d) Substances intended for use as a component of any
1 24 article specified in subparagraph subdivision (a), (b), or
1 25 (c).
1 26 (2) "Drug" does not include devices or their components,
1 27 parts, or accessories.
1 28 b. "Trace amounts" means trace amounts as defined by the
1 29 United States food and drug administration.
1 30 2. Except as provided in subsections 3 and 4:
1 31 a. Beginning July 1, 2008, a drug or vaccine administered
1 32 in this state shall not contain more than trace amounts of
1 33 mercury.
1 34 b. Beginning July 1, 2010, a drug or vaccine administered
1 35 in this state shall not contain any amount of mercury.
2 1 3. a. Subsection 2 shall not apply if the recipient of
2 2 the drug or vaccine, or the recipient's parent or legal
2 3 guardian if the recipient is a minor, has signed a consent
2 4 form as provided in paragraph "b", prior to receiving such
2 5 drug or vaccine. The person administering such drug or
2 6 vaccine shall retain the signed consent form, or a copy
2 7 thereof, in the recipient's permanent medical record.
2 8 b. The department shall develop and make available for use
2 9 a standardized consent form providing that the recipient or
2 10 the recipient's parent or legal guardian:
2 11 (1) Has been informed that the drug or vaccine to be
2 12 administered to the recipient contains mercury.
2 13 (2) Has been advised of all of the following:
2 14 (a) That all forms of mercury are dangerous toxins.
2 15 (b) That exposure to even low levels of mercury may result
2 16 in irreversible systemic damage to the brain, nervous system,
2 17 or other organ or system of the body.
2 18 (c) That mercury ingestion may cause adverse behavioral
2 19 and other changes.
2 20 (3) Consents to the administration of the drug or vaccine.
2 21 4. a. The director may exempt a drug or vaccine that
2 22 contains mercury from the prohibitions in subsection 2 if the
2 23 director finds that an actual or potential incident or public
2 24 health emergency, including an epidemic or medical supply
2 25 shortage, makes necessary the administration of such drug or
2 26 vaccine.
2 27 b. The conditions of an exemption issued pursuant to
2 28 paragraph "a" include all of the following:
2 29 (1) The exemption shall not be issued for a period
2 30 exceeding twelve months.
2 31 (2) Within forty=eight hours after the issuance of the
2 32 exemption, the director shall notify the state board of
2 33 health, the governor, and the general assembly or the
2 34 legislative council, and shall notify the public upon request.
2 35 (3) The administration of the drug or vaccine which is the
3 1 subject of the exemption is subject to the requirements of
3 2 subsection 3.
3 3 c. Subsequent exemptions for the same drug or vaccine for
3 4 the same incident or public health emergency may be issued for
3 5 periods not exceeding twelve months if the director determines
3 6 that such incident or emergency requires an extension or
3 7 renewal of the prior exemption. The extended or renewed
3 8 exemption shall meet all of the requirements of this
3 9 subsection.
3 10 5. A person who knowingly administers a drug or vaccine in
3 11 violation of this section is guilty of a simple misdemeanor.
3 12 Such person may also be civilly liable for such
3 13 administration. A person awarded damages in a civil action
3 14 arising from a violation of this section is entitled to
3 15 reimbursement for reasonable attorney fees and court costs.
3 16 Sec. 3. Section 135.39B, Code 2007, is repealed.
3 17 Sec. 4. EFFECTIVE DATE. The sections of this Act enacting
3 18 section 135.39E and repealing section 135.39B, Code 2007, take
3 19 effect July 1, 2008.
3 20 EXPLANATION
3 21 This bill relates to the administration of drugs and
3 22 vaccines containing mercury.
3 23 The bill requires the department of public health to
3 24 randomly test drugs and vaccines administered in this state
3 25 for mercury content and to publish its findings.
3 26 The bill prohibits the administration of a drug or vaccine
3 27 containing more than trace amounts of mercury on or after July
3 28 1, 2008, and prohibits the administration of a drug or vaccine
3 29 containing any amount of mercury on or after July 1, 2010.
3 30 However, the bill allows such administration with the informed
3 31 consent of the recipient or the recipient's parent or legal
3 32 guardian.
3 33 The bill also allows the director of public health to issue
3 34 an exemption from the prohibitions if the director finds that
3 35 an actual or potential incident or public health emergency
4 1 makes necessary the administration of such drug or vaccine.
4 2 A person who knowingly administers a drug or vaccine in
4 3 violation of the bill is guilty of a simple misdemeanor. Such
4 4 person may also be civilly liable for such administration and
4 5 entitled to attorney fees and court costs.
4 6 The bill repeals the current provisions prohibiting early
4 7 childhood immunizations from containing more than trace
4 8 amounts of mercury, effective July 1, 2008, when the bill's
4 9 provisions restricting all drugs and vaccines go into effect.
4 10 LSB 2297HH 82
4 11 nh:rj/gg/14