|
FDA Semi-Annual
Regulatory Agenda Targets
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List of OTC drug and dietary supplement
priorities from HHS semi-annual regulatory agenda in
the April 26 Federal Register.
|
|
Category
|
Status
|
Date
|
|
Antacid
products
|
Final actions;
sodium bicarbonate labeling / overindulgence
labeling
|
TBD
|
|
Antidiarrheal
drugs
|
NPRM; new
labeling
|
TBD
|
|
Category II active
ingredients
|
Final action;
certain OTC drug ingredients not GRASE or
misbranded
|
TBD
|
|
Cough/cold
(antihistamine)
|
NPRM;
claims
|
3/11
|
|
Cough/cold
(allergy/
bronchodilators/antiasthmatics)
|
NPRM; pediatric
dosing
|
12/10
|
|
Cough/cold
(bronchodilators)
|
Final action;
single-ingredient labeling
|
9/10
|
|
Cough/cold
(combinations)
|
Final action;
monograph amendment
|
3/11
|
|
Cough/cold (nasal
decongestants)
|
Final action;
phenylpropanolamine
|
TBD
|
|
Dietary supplement
GMPS
|
Final action; IFR
on identity testing waivers
|
TBD
|
|
Internal analgesics
(acetaminophen)
|
NPRM;
safety
|
3/11
|
|
NPRMs; pediatric
dosing / sodium bicarbonate monograph
amendment
|
TBD
|
|
External
analgesics
|
Final action; GRASE
for patches, plasters and poultices
|
12/10
|
|
Infant
formula
|
Final action;
quality control procedures, notification requirements,
records and reports, and quality factors
|
10/10
|
|
Labeling
requirements
|
End review of
current regulation
|
5/10
|
|
Final action;
convenience-size packages
|
TBD
|
|
Laxatives
|
NPRM; professional
labeling for sodium phosphate products
|
10/10
|
|
NPRM; professional
labeling for other laxative products
|
TBD
|
|
Final action;
monograph amendment
|
TBD
|
|
Modernization of
food GMPs
|
NPRM
|
3/11
|
|
Ophthalmic
products
|
Final action;
monograph for emergency first-aid eyewash
products
|
TBD
|
|
Oral health
care
|
NPRM; monograph
amendment for products indicated to reduce or prevent
dental plaque and gingivitis
|
TBD
|
|
Overindulgence in
food/drink products
|
Final action;
products containing bismuth subsalicylate
|
TBD
|
|
Skin protectant
products
|
Final actions;
ingredients for diaper rash / fever blisters and cold
sores
|
3/11
|
|
Sunscreen
|
NPRM; time and
extent applications
|
7/10
|
|
NPRM;
effectiveness
|
10/10
|
|
Final action;
UVA/UVB formulation
|
10/10
|
|
NPRM; sunscreen and
insect repellent products
|
TBD
|
|
Skin bleaching
products
|
Final action;
hydroquinone
|
TBD
|
|
Stimulant drug
products
|
NPRM; hangover
amendment
|
TBD
|
|
Topical
antimicrobials
|
NPRMs; food handler
products / testing requirements for health care
professional products / consumer products
|
TBD
|
|
Urinary
analgesics
|
NRPM; pain
relief
|
TBD
|
|
Vaginal
contraceptive products
|
NPRM;
monograph
|
TBD
|
|
Weight-control
products
|
NRPM; use of
benzocaine
|
TBD
|
|
Final action;
phenylpropanolamine
|
TBD
|
