CHAPTER 229

FORMERLY

HOUSE BILL NO. 322

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO IMMUNIZATIONS CONTAINING MERCURY.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE :

Section 1. Amend §510, Title 16 of the Delaware Code by striking §510 in its entirety and by substituting in lieu thereof the following:

"§510. Immunizations containing mercury.

(a) A vaccine containing mercury may not be made available to a medical provider in this State for administration to children under 8 years of age or to pregnant women, or to both. A vaccine containing mercury may not be administered to a child who is under 8 years of age or to a pregnant woman, or to both, notwithstanding the expiration date of the vaccine.

(b) Subsection (a) of this section does not apply if:

(1) the Director is informed by a person authorized to sell or to administer a vaccine that a mercury-free vaccine against a specific disease is not available to a child under 8 years of age or to a pregnant woman, or to both, in a medically necessary period of time, and the Director determines that an FDA-approved, mercury-free vaccine is not manufactured or cannot be obtained from other medical providers, manufacturers, distributors, agencies, jurisdictions, or by any other means within the medically necessary period of time; or

(2) the Director determines that an emergency or epidemic exists necessitating the vaccination of groups of individuals within the State, including children under 8 years of age or pregnant women, or both, and an FDA-approved mercury-free vaccine is not manufactured, or the quantity is insufficient and additional mercury-free vaccine cannot be obtained from other medical providers, manufacturers, distributors, agencies, jurisdictions, or by any other means within the medically necessary period of time; or

(3) the Director determines that a shortage of vaccine exists which could threaten the health of groups of individuals within the State, including children under 8 years of age or pregnant women, or both, and additional mercury-free vaccine cannot be obtained from other medical providers, manufacturers, distributors, agencies, jurisdictions, or by any other means within the medically necessary period of time.

(c) A determination made pursuant to subsection (b) of this section is enforceable for a time period specified by the Director. The Director shall rescind the time period when he or she determines that a sufficient amount of the FDA-approved, mercury-free vaccine is available.

(d) (1) If the Director determines that subsection (a) of this section does not apply pursuant to subsection (b) of this section, the Division shall report the determination within 72 hours by a posting on the Division of Public Health website. If subsection (b)(1) of this section applies, the Division shall report the specific disease, the vaccine, the time period for which the vaccine containing mercury is approved, and the number of individuals under 8 years of age or pregnant receiving the vaccine containing mercury.

(2) If subsection (b)(2) or (3) of this section applies, the Division shall report the specific disease, the vaccine, and the time period for which the vaccine containing mercury is approved.

(3) The Division shall issue and disseminate for public review an annual report listing all determinations made pursuant to this section, without revealing the identity of any persons denied or given a vaccine.

(e) A vaccine containing mercury may not be administered to a child under 8 years of age until a parent or legal guardian of the child has been informed by the person administering the vaccine that the vaccine contains mercury, that the person administering the vaccine believes the vaccine to be medically necessary, and that the Director of Public Health or the Director's designee has made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in subsection (b) of this section. If the parent or legal guardian of a child cannot be reached in the period of time deemed medically necessary by the person administering the vaccine, the parent or guardian must be notified in writing at the earliest possible time that the vaccine administered contained mercury, that the person administering the vaccine believed the vaccine to be medically necessary, and that the Director of Public Health or the Director's designee made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in subsection (b) of this section.

(f) A vaccine containing mercury may not be administered to a pregnant woman until she has been informed by the person administering the vaccine that it contains mercury, that the person administering the vaccine believes the vaccine to be medically necessary, and that the Director of Public Health or the Director's designee has made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in subsection (b) of this section.".

Section 2. This Act is retroactively effective on January 2, 2008.

Approved May 22, 2008