Legal Eagle Eye Newsletter for the Nursing Profession(5)9 Sep 97
Quick Summary: The FDA's new regulations take effect January 26, 1998 requiring infectious disease testing, donor screening and recordkeeping to help prevent HIV and hepatitis transmission through human tissue used in transplantation.
The FDA is making available a document called "Guidance for Screening and Testing of Donors of Human Tissue Intended for Transplantation." It provides specific concrete guidelines for healthcare facilities who must comply with the new regulations.
There are several ways to obtain information. FEDERAL REGISTER, July 29 1997, Pages 40429 - 40447.
On July 29, 1997 the Food and Drug Administration issued a rule in final form to require certain infectious disease testing, donor screening and recordkeeping to help prevent the transmission of the HIV and hepatitis viruses through human tissue used in transplantation. The FDA has been considering public comments and working on this issue since an interim rule was first published on December 14, 1993.
The new regulations apply to establishments and persons engaged in the recovery, screening, testing, processing, storage or distribution of human tissue.
According to the FDA, the new regulations do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility. The regulations do not apply to autologous human tissue.
The new regulations are too lengthy to reproduce here. There are several ways for those interested to obtain copies of the actual regulations themselves. There is also a guidance document being made available by the FDA.
The regulations appear in the July 29, 1997 issue of the Federal Register (Vol. 62, No. 145). The Federal Register is on the reference shelves of many public, academic and law libraries. The FDAs article starts on page 40429; the regulations themselves start on page 40444.
To download the FDAs new regulations on the Internet from the Federal Register, go to http://www.access.gpo.gov/ su_docs/aces/aces140.html. When you see Federal Register Online Via GPO Access, scroll down to Issue Date and enter 7/29/97. Type in "page 40430" for Search Terms. Be sure to include the quotation marks. (The article starts in the middle of page 40429. It works better at this stage to conjure up the first full page of the document you want, i.e., "page 40430".) Scroll down and press SUBMIT. When Federal Register Search Results appear, scroll down to Human Tissue Intended for Transplantation and press Text to download the document. The regulations are at the very end of the document.
To obtain "Guidance for Screening and Testing of Donors of Human Tissue Intended for Transplantation" go to http://www.fda.gov/cber/guidelines.htm. Scroll down to the document title and download it.
According to the FDA, the guidance document can also be requested in writing from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The FDA asks for a self-addressed adhesive return address label.
The FDA has indicated it will accept phone requests for the guidance document at 1-800-835-4709 or (301) 827-1800 and fax requests at 1-888-CBER-FAX or (301) 827-3844 and e-mail requests at email@example.com.
FEDERAL REGISTER, July 29 1997,
Pages 40429 - 40447.