Food and Drug Administration Regulates Sale of Semen

In 2005, the FDA began regulating the sale of semen within the United States (though regulating might be too strong a word - they basically institutionalized practices that had already become the norm within the cryo banking community). Cryo banks that don't comply with FDA regulations don't risk being shut down but are not allowed to say they're FDA approved, which in the highly competitive sperm-banking business, might mean losing a leg-up to a competitor.

This is relevant to all things donor insemination, of course, because as mild as the FDA's regulations might be, it's one of the few regulatory gestures made by the Federal government towards the medically assisted reproductive industry. For the most part, Federal and state governments have wanted to steer clear of any kind of regulation, intentionally leaving the details of the baby-making business in the (no doubt, benevolent) hands of the free market.

Here's the FDA's statement:

Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. CBER does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.

Parts 1270 and 1271 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease. One final rule requires firms to register and list their HCT/Ps with FDA. The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation. The third final rule establishes current good tissue practices for HCT/Ps. FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The new requirements are intended to improve protection of the public health while minimizing regulatory burden.