N.J. Admin. Code § 8:8-8.16

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:8-8.16 - Immunized donor

(a) If specific immunization of a donor is to be performed, the selection and scheduling of the injection of the antigen, and the evaluation of each donor's clinical response, shall be by a qualified physician.

(b) Any material used for immunization shall be either a product licensed under Section 351 of the Public Health Service Act for such purpose or one specifically approved by the Director, Center for Biologics Evaluation and Research.

(c) Immunization procedures shall be on file at each plasmapheresis center where immunizations are performed.

(d) Each donor to be immunized shall be instructed regarding possible hazards associated with use of his blood at other blood banks and each shall agree that he will not donate blood elsewhere without first divulging his immunization status.

(e) Informed consent of the donor shall be obtained.

N.J. Admin. Code § 8:8-8.16

Recodified from 8:8-7.13 by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
In (b), substituted "Center for Biologics Evaluation and Research" for "Office of Biologics"; in (e), substituted "shall" for "must".