The Cove Business Standards Discussion Forums
Contract Manufacturing - OTC (Over the Counter) vs Prescription
UL - Underwriters Laboratories - Health Sciences
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Contract Manufacturing - OTC (Over the Counter) vs Prescription


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
anda (abbreviated new drug applications), cgmp (current good manufacturing practices), contract manufacturing, drugs (medicinal), over the counter (see otc), prescription drugs, relabeling (of products)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 4th August 2016, 03:26 PM
rwend07

 
 
Total Posts: 42
Please Help! Contract Manufacturing - OTC (Over the Counter) vs Prescription

Hey all,

All of my experience has been in medical device regulatory, with no experience in the drug industry. We are currently trying to source an OTC drug (listed in monograph) to include in a kit. As I understand it, we can outsource all aspects of manufacturing of the drug (and cGMP) to the contract manufacturing company outside of final release of product correct? If all manufacturing is done at their facility and a quality agreement has been created assigning all cGMP responsibility to that facility, is there still a registration requirement for our facility?

Secondly, if a company has done an ANDA, can we "re-label" their drug for use in our kit? In this case, are there any different registrations required on our part?

I have spent several hours researching the subject, but haven't found a single place that this situation is addressed directly, so any help would be appreciated. Drug regulations are very new and very confusing to me.

Thanks,
rwend07

Sponsored Links
  Post Number #2  
Old 20th September 2016, 04:08 PM
QA-Man

 
 
Total Posts: 135
Re: Contract Manufacturing - OTC (Over the Counter) vs Prescription

There is a distinction between repacker, relabeler, and private label distributor in pharmaceuticals. These terms can be used a little differently than they are used in the medical device industry. Repackers and relabelers have to register and list, private label distributors do not. Sounds like you're a private label distributor and not a relabeler.

The FDA just released a final rule here regarding this topic which goes into effect on November 29th. The following is copied from page 13 of the federal register with the final rule.

The term ‘‘private label distributor’’ is defined in 207.1 of this final rule to mean, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed.

Private label distributors do not—by reason of their status as private label distributors—have an obligation to register establishments or list drugs. They must have labeler codes, obtained under new 207.33(c), and they may submit drug listing information or establishment registration information if acting as the authorized agent of a registrant on whose behalf the information is submitted.


Relabelers and repackers do have to register and list.
Thank You to QA-Man for your informative Post and/or Attachment!
  Post Number #3  
Old 21st September 2016, 10:09 AM
rwend07

 
 
Total Posts: 42
Re: Contract Manufacturing - OTC (Over the Counter) vs Prescription

Yes, that is exactly what I was looking for. Thank you for the response!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Prescription or non-prescription -Labeling/intended use makes the distinction? SmallD Other US Medical Device Regulations 4 21st December 2012 11:47 AM
Generic Contract Manufacturing of Generic Prescription Medications prami Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3 17th May 2012 02:19 PM
Over The Counter (OTC) vs. POM (Prescription Only Medicine) pseudoazurin Other Medical Device Regulations World-Wide 11 2nd May 2012 11:18 AM
Prescription vs. OTC (Over the Counter) Medical Device in Canada quest Canada Medical Device Regulations 4 28th February 2011 11:45 AM
Prescription Only vs. Over The Counter Pharmaceuticals because of State Laws J0anne 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5 2nd September 2010 11:09 AM



The time now is 06:01 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"