Contract Manufacturing - OTC (Over the Counter) vs Prescription

rwend07

Involved In Discussions
#1
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
 
Elsmar Forum Sponsor

QA-Man

Involved In Discussions
#2
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.
 
Thread starter Similar threads Forum Replies Date
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
Ed Panek Moving from Contract Manufacturing to Production In-House ISO 13485:2016 - Medical Device Quality Management Systems 3
S 21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing Other US Medical Device Regulations 1
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Q Converting Manufacturing Drawings from a Contract Supplier ISO 13485:2016 - Medical Device Quality Management Systems 7
Ajit Basrur Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing? Other US Medical Device Regulations 1
D TS16949 & Design Responsibilities of a Contract Manufacturing Factory IATF 16949 - Automotive Quality Systems Standard 1
F Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J How to structure a DHF when all manufacturing is done by Contract Maufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J How to change the Manufacturing Site to another Contract Manufacturer Japan Medical Device Regulations 1
P Generic Contract Manufacturing of Generic Prescription Medications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
N Special Contract Manufacturing or 510k Licensing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Contract Review Template for an Inspection, Repair and Manufacturing Facility wanted Document Control Systems, Procedures, Forms and Templates 2
R Role of Qualified Person (QP) in Contract Manufacturing Pharma Business Quality Manager and Management Related Issues 2
M Tainted wipes maker Triad sues contract manufacturing customer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Sub-Contract Manufacturing of a Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Sample Manufacturing Plan or Template for Medical Device Contract Manufacturer Document Control Systems, Procedures, Forms and Templates 5
R 7.2.1 Customer Requirements Checklist for a Small Contract Manufacturing Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G Medical Device Contract Manufacturing Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S "Contract Manufacturing" - How to review the existing ISO14001 documents ISO 14001:2015 Specific Discussions 1
I Contract Manufacturing Company - What does contract manufacturing company mean? Other Medical Device and Orthopedic Related Topics 4
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Requirements of Contract Manufacturing in respect to GMP? ISO 13485:2016 - Medical Device Quality Management Systems 13
E Environmental Screening of PCBAs in High Volume Electronics Contract Manufacturing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Contract Review Procedure for a Manufacturing Business Contract Review Process 2
C Contract Manufacturing of Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 11
N Contract Review Question - China manufacturing site to exclude 7.2.2? Contract Review Process 6
N Contract Review Consolidation - Two different manufacturing sites Contract Review Process 2
T Electronic Industry Contract Manufacturing - Customer notification needed? Supplier Quality Assurance and other Supplier Issues 1
M Contract Review Process - Risk Analysis - 7.2.2.2 Manufacturing feasibility Contract Review Process 4
Scott Catron Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
M Industry DPMO Standards - Contract Electronics Manufacturing processes Statistical Analysis Tools, Techniques and SPC 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom