Dear Thiru,
I think that you are confusing controlled substances which are
regulated by the DEA with the various categories of OTC drugs that
fall under FDA's OTC monograph system.
You will find the various schedules of controlled substances in 21
CFR Part 1308
(http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr1308_07.html) in
sections 1308.11 through 1308.15. You will find the OTC monographs
and related information in 21 CFR Parts 328 through 369
(http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfrv5_07.html). The
combination product that you have described is covered by 21 CFR
Parts 341 and 343.
Best regards,
Rick Flora
President/General Partner
R. FLORA & ASSOCIATES
26391 Crown Valley Parkway, Suite 210
Mission Viejo, CA 92691-7322
USA
Email: rflora@rflora.com
|