OTC Pharmaceuticals Labeling Submissions to the FDA

#1
Hi all,

I work at a company that does some OTC repackaging. Our SME for labeling is on an unexpected medical leave of absence, leaving me (his back-up) as the point person for labels. For the most part, I’m fairly comfortable with the OTC monographs and labeling requirements, and I understand how we’re assigning NDCs and ensuring no duplication occurs, so I believe those aspects of the labeling process is under control. However, we’re going live on a product soon, meaning I need to do the actual label submission to the FDA, and I have very little understanding of SPL or how this process works. The documents I found on the FDA’s website aren’t really user-friendly for this process.

Could anyone point me to a “dummies” guide anywhere? Or towards any resources that may help with this project?
:thanx:
Thank you!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Z Labeler Code - Private labelling for OTC (Over the Counter) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Q Legal Manufacturer OTC Drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
S OTC and Prescription use in EU regulation EU Medical Device Regulations 3
G How is the labeling of units cleared for both Rx and OTC uses handled? US Food and Drug Administration (FDA) 4
R US FDA Mandatory Labelling contents for an OTC medical device US Food and Drug Administration (FDA) 0
D FDA Registration - MD, OTC or Dietary Supplement US Food and Drug Administration (FDA) 0
O 510(k) Exempt OTC - Can we sell this device on Amazon? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Class II to OTC conversion of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Contract Manufacturing - OTC (Over the Counter) vs Prescription Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
R OTC with Rx Predicate - 510(k) for a Class II medical device Other US Medical Device Regulations 6
Q FDA Requirements for Contract Manufacturers and OTC products US Food and Drug Administration (FDA) 4
B Anyone Attending OTC next week in Houston? (Offshore Technology Confernce) Oil and Gas Industry Standards and Regulations 0
S FDA Approval of Multifunction Device - OTC functions AND Prescription together! Other Medical Device and Orthopedic Related Topics 4
H What is required to support changes to API Manufacturers in OTC Drugs? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
C Very Small OTC (Over The Counter) Pharmaceutical Company Requirements US Food and Drug Administration (FDA) 6
S Switching 510(k) product from Prescription to OTC US Food and Drug Administration (FDA) 2
B New 510k for change to Intended Use - Prescription to OTC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S FDA and OTC (Over the Counter) Software Use Classification Medical Information Technology, Medical Software and Health Informatics 9
AnaMariaVR2 FDA hits China Plant - OTC DRUG Nationwide Recall US Food and Drug Administration (FDA) 2
E Guidance/Tips to go Rx to OTC for Class II Medical Device Other US Medical Device Regulations 6
P Over The Counter (OTC) vs. POM (Prescription Only Medicine) Other Medical Device Regulations World-Wide 11
H OTC (Over The Counter) Wipe Product Labeling Guidelines - Question Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
E Does anyone know what a Part Number for an OTC Monographed Drug is? US Food and Drug Administration (FDA) 3
S IFU for combined OTC Medical Device in light of IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Prescription vs. OTC (Over the Counter) Medical Device in Canada Canada Medical Device Regulations 4
N OTC (Over The Counter) Product FDA Label Change Requirements US Food and Drug Administration (FDA) 2
Scott Catron 21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Prescription Devices and OTC Devices Labeling differences US Food and Drug Administration (FDA) 7
M Can a prescription type material be used as a predicate for an OTC material? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
O Cosmetics (otc) with Drugs - Expiration dates and three years stability / shelf life ISO 13485:2016 - Medical Device Quality Management Systems 1
A What is Classification of Class A Certificate? OTC health care and consumer products Various Other Specifications, Standards, and related Requirements 1
K Seeking: Source for IOS International Symbology for OTC products ISO 13485:2016 - Medical Device Quality Management Systems 2
Q OTC S/W in Medical Devices (managing obsolescence) ISO 13485:2016 - Medical Device Quality Management Systems 2
E Company A supplies pharmaceuticals to the MOI - Who is responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Pharmaceuticals Warehouse temperature control (room temperature) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
C Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
N Regulatory Affairs Certificate (Medical Device and Pharmaceuticals Other Medical Device Related Standards 7
B UL's STR Registration for Pharmaceuticals Registrars and Notified Bodies 2
R Environmental Monitoring in Pharmaceuticals Manufacturing in EU Benchmarking 2
S FDA Training courses on Pharmaceuticals in the US Training - Internal, External, Online and Distance Learning 3
L Shipping Medical Devices and Pharmaceuticals Direct to Physicians - Puerto Rico US Food and Drug Administration (FDA) 4
L Pharmaceuticals Registration Submission Format in Singapore Other Medical Device Regulations World-Wide 3
J0anne Prescription Only vs. Over The Counter Pharmaceuticals because of State Laws 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q Quality Engineering in Pharmaceuticals Career and Occupation Discussions 9
S What if I find a defect after AQL (Inspection)? Pharmaceuticals AQL - Acceptable Quality Level 1
L Recall Process for Pharmaceuticals - Example wanted Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 9
R Rework vs. Reprocess - Definitions - Pharmaceuticals Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
J Dual Quality Systems? Pharmaceuticals and Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom