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[资源] Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310, 352, 700, and 740
[Docket No. 78N–0038]
RIN 0910–AA01
Sunscreen Drug Products For Over-
The-Counter Human Use; Final
Monograph
AGENCY: Food and Drug Administration,
HHS.
ACTION: Final rule.

SUMMARY: The Food and Drug
Administration (FDA) is issuing a final
rule in the form of a final monograph
establishing conditions under which
over-the-counter (OTC) sunscreen drug
products are generally recognized as
safe and effective and not misbranded as
part of FDA’s ongoing review of OTC
drug products. FDA is issuing this final
rule after considering public comments
on the agency’s proposed regulation,
which was issued in the form of a
tentative final monograph, and new data
and information on sunscreen drug
products that have come to the agency’s
attention. FDA is also issuing final rules
regarding the labeling of certain
cosmetic products to inform consumers
that these products do not provide
protection from the sun.
EFFECTIVE DATES: This regulation is
effective May 21, 2001 for parts 310,
352, and 700 and is effective May 22,
2000 for part 740.
FOR FURTHER INFORMATION CONTACT: John
D. Lipnicki, Center for Drug Evaluation
and Research (HFD–560), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
2222.
[search]Sunscreen[/search]

[ Last edited by chemredox on 2007-12-18 at 11:39 ]
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