OTC Sunscreen Drug Product Delays
In the September 3, 2004 issue of the Federal Register (Volume 69, Number 171), the Food and Drug Administration (FDA) announced that effective October 4, 2004, it was delaying the implementation date for the drug facts rule as it applies to OTC sunscreen drug products until further notice.
In making this announcement, the FDA stated that it had "determined that a final amendment of the sunscreen FM will, not be completed by the May 16, 2005, final implementation date for the, OTC drug facts rule.
FDA hopes to publish the final amendment of the, sunscreen FM shortly after the May 16, 2005, implementation date. Thus, to avoid dual relabeling that might be required at two closely related, time intervals by two different final rules, FDA believes the final, implementation date for the OTC drug facts rule should also be, concurrently delayed as it applies to OTC sunscreen drug products."
Complete details are available at:
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-18842.htm
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-18842.pdf
Source: Convergent Cosmetics, Inc.
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