You can review CFR PART 352 - "SUNSCREEN DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE" for elaborated information.
v These products are defined in the CFR as OTC monographs, so
if the product fully complies too the words in part 352, then no
registration of the product is required.
v However, manufacturer registration is needed, and listing of
the drug product is necessary.
v GMP compliance is a must.
v my question from our Colleagues is:
Are in practice OTC mongraphial manufactures, being reviewed for GMP
compliance by the FDA?
Please note these paragraphs from CFR part 330.1
An over-the-counter (OTC) drug listed in this subchapter is generally
recognized as safe and effective and is not misbranded if it meets
each of the conditions contained in this part and each of the
conditions contained in any applicable monograph. Any product which
fails to conform to each of the conditions contained in this part and
in an applicable monograph is liable to regulatory action.
(a) The product is manufactured in compliance with current good
manufacturing practices, as established by parts 210 and 211 of this
chapter.
(b) The establishment(s) in which the drug product is manufactured is
registered, and the drug product is listed, in compliance with part
207 of this chapter. It is requested but not required that the number
assigned to the product pursuant to part 207 of this chapter appear
on all drug labels and in all drug labeling. If this number is used,
it shall be placed in the manner set forth in part 207 of this
chapter.
David Wagner - Signet Consultants
Israel 30900
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