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Statement of Compliance with FDA Regulations

The FDA published final rules for the collection, processing, storage and distribution of reproductive tissues (sperm, embryos, oocytes) that took effect on May 25, 2005.

These regulations were established in order to require reproductive tissue banks to employ donor screening and testing procedures, as well as good manufacturing practices and quality systems that reduce the risk of introduction, transmission or spread of communicable disease from human reproductive tissues.

Both Pacific Reproductive Services facilities are registered with the FDA and are in compliance with FDA regulations (see our Statement of Compliance that follows).

Regulatory Documents (click to download)

Statement of Compliance with FDA Regulations

This certifies that Pacific Reproductive Services, Inc. is in compliance with all relevant regulatory requirements of Reproductive Tissue Banks, as set forth in 21 CFR Part 1271 by the U.S. Food and Drug Administration (FDA).

Based on the results of medical, social and behavioral history, as well as physical examination and infectious disease testing, all PRS sperm donors have been determined to meet FDA eligibility requirements.

Screening tests of all PRS donors are performed by laboratories certified to perform such testing under the Clinical Laboratory Improvement Amendment of 1998, using tests approved by the FDA. PRS donors must have tested negative or non-reactive to the required tests during initial screening.

All PRS donors’ specimens are held in quarantine for at least six (6) months, after which and prior to release, the donor again tests negative or non-reactive to the required tests.

A summary of records, including a list of tests and results used to determine donor eligibility is enclosed with each specimen delivery. These records are reviewed by a qualified licensed clinician, who has determined the donor specimens to be suitable for release and for administration to a recipient.

All supplies and reagents used in the collection, processing, storage and distribution of donor specimens are in compliance with relevant FDA requirements.

All records relevant to the screening of the donor, as well as the collection, processing, storage and distribution of donor specimens are on file at:

Pacific Reproductive Services, Inc.
444 Deharo St., Suite 222
San Francisco, CA 94107
415-487-2288
Pacific Reproductive Services
65 Madison Ave, Suite 610
Pasadena, CA 91101