(a) The Texas Department of Health adopts by reference U.S. Department of Health, Education and Welfare regulations on intrauterine contraceptive devices published in 21 Code of Federal Regulations, Chapter I, Part 310, §310.502, "Intrauterine devices for human use for the purpose of contraception," and Part 801, §801.425, "Professional and patient labeling for intrauterine contraceptive devices." These regulations became effective November 7, 1977.
(b) The purpose of these federal regulations is that the U.S. Food and Drug Administration is establishing uniform professional and patient labeling for intrauterine devices (IUDs). The labeling will assist professionals and patients in deciding whether to use an IUD for contraception; it includes requirements for instructions on insertion and usage, contraindications, warnings, adverse reactions, precautions, side effects, and information on IUD effectiveness.
(c) Copies ofthe regulations referred in this section are indexed and filed in the Texas Department of Health, Maternal and Child Health Services Division, 1100 West 49th Street, Austin, Texas 78756.
Source Note: The provisions of this §37.3 adopted to be effective December 13, 1977, 12 TexReg 4780.