The Monograph The SIA also required the FDA to finalize and
The monograph program was supposed to be an
put into effect the sunscreen monograph
efficient mechanism through which compliant
within five years of SIA enactment, or by
OTC drugs could be marketed without the
November 26, 2019.
extensive and expensive individual approval that’s required of non-OTC drugs. For example, if
Some background is necessary to understand
Company X makes several different cold remedies
what a monograph is and why the sunscreen
that comply with that product’s monograph
monograph was particularly problematic:
conditions, the company can market all of those products in the U.S. without getting each product
Created in 1972, the monograph program was
approved individually.
intended to create a system to ensure the safety of OTC drugs that were already being
But the monograph program faced challenges,
sold in the U.S. as well as those that would be
such as the fact that some monographs had never
introduced in the future. It established
been finalized and/or put into effect in the years
conditions (such as active ingredients, dosage
since 1972.
level, warnings, and adequate directions for use) under which an OTC drug in a given
The sunscreen monograph was one of those that
therapeutic category (such as sunscreen,
was never put into effect (until 2020; more on this
antacids, and cold remedies—approximately
date, below). In 1999, after more than two decades
25 categories) is GRASE for its intended use.
of discussions and drafts, the “final monograph” was published, and the 16 active ingredients noted above were deemed GRASE. But— importantly—this final monograph was stayed (not put in effect) indefinitely because at that time FDA had not yet established UVA/broadspectrum testing and labeling requirements. So for the last 20 years, with no finalized sunscreen monograph in effect, the 1999 version was generally followed by default (and in 2011, the FDA issued guidance saying industry should follow the 1999 stayed monograph and the 2011 testing and labeling requirements until a final monograph was put into effect). So these 16 ingredients were deemed GRASE but the monograph itself was in limbo due to the stayed status. In February 2019—as the November 2019 final monograph deadline set by SIA neared—the FDA issued a “proposed rule,” which was the mechanism at that time to announce an intended change in the monograph and to ask for public comment.
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