CHAPTER 132

FORMERLY

HOUSE SUBSTITUTE NO. 1

FOR

HOUSE BILL NO. 194

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

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

Section 1. Amend Chapter 5, Title 16 of the Delaware Code, by striking § 510 in its entirety and replacing it with the following:

Ҥ 510. Immunizations Containing Mercury.

(a) No vaccine containing mercury shall be made available to a medical provider in this State for administration to children under eight (8) years of age or to pregnant women. No vaccine containing mercury shall be administered by a medical provider in this State to a child who is under eight (8) years or to pregnant women, notwithstanding the expiration date thereof.

(b) Shall not apply when:

(1) the Director of the Division of Public Health or their designee is informed by a medical provider that no mercury-free vaccine against a specific disease is available to an individual patient under eight (8) years of age or to a pregnant woman in a medically necessary period of time, and the Director or their designee determines that a FDA approved mercury-free vaccine is not manufactured or cannot be made available from other medical providers, manufacturers, distributors, agencies, jurisdictions or by any other means within the medically necessary period; or

(2) the Director of the Division of Public Health, or their designee determines that an emergency or epidemic exists necessitating the vaccination of groups of individuals within the State including children under eight (8) years of age or pregnant women, and a FDA approved mercury-free vaccine is not manufactured, or the quantity is insufficient and additional mercury-free vaccine cannot be made available from other medical providers, manufacturers, distributors, agencies, jurisdictions or by any other means; or

(3) the Director of the Division of Public Health or their designee determines that a shortage of vaccine exists which could threaten the health of groups of individuals within the State including children under eight (8) years of age or pregnant women, and additional mercury-free vaccine cannot be made available from other medical providers, manufacturers, distributors, agencies, jurisdiction or by any other means.

(c) A determination made pursuant to § 510(b) will be in force from a time period specified by the Director of the Division of Public Health. Any such determination will be rescinded when the Director of the Division of Public Health determines that an FDA-approved mercury-free vaccine is, or can be made, adequately available.

(d) When the Director of the Division of Public Health or their designee determines that § 510(a) does not apply pursuant to § 510(b), the Division shall report the determination within 72 hours by a posting on the Division of Public Health website. If § 510(b)(1) applies the Division shall report the specific disease, vaccine, time period the mercury containing vaccine is approved, and the number of individuals receiving vaccines which contain mercury under that determination. If § 510(b)(2) or (3) applies the Division shall report the specific disease, vaccine, and the time period the mercury containing vaccine is approved. The Division shall also issue and disseminate for public review an annual report listing all such determinations.

(e) No vaccine containing mercury shall be administered to children under eight (8) years of age until their parent or legal guardian has been informed by the provider administering the vaccine that it contains mercury, that the provider believes the vaccine to be medically necessary, and that the Director of Public Health or their designee, has made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in § 510(b). If the parent or legal guardian cannot be reached in the period of time deemed medically necessary by the attending physician, the parent or guardian must be notified in writing at the earliest possible time that the vaccine administered contained mercury, that the provider believed the vaccine to be medically necessary, and that the Director of Public Health or their designee, made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in § 510(b).

(f) No vaccine containing mercury shall be administered to pregnant women until they have been informed by the provider administering the vaccine that it contains mercury, that the provider believes the vaccine to be medically necessary, and that the Director of Public Health or their designee has made a formal determination that the vaccine may be administered due to the existence of any of the circumstances described in § 510(b).

Approved July 12, 2007