FDA product Labeling Question - Re-selling and Re-labeling

A

azaplas

#1
Hello, I'm a new poster here! I work for a dental laser company and I would like to know if anyone has some insight on this matter.

The company is looking into buying an already FDA approved pharmaceutical topical anesthetic from another company and re-labeling it for our company, and re-selling it to customers.

Is this allowed, or are we required to have the product FDA-approved under our name in order to re-label it under our name?

What are the guidelines regarding re-selling and re-labeling an already approved FDA product?

Where I can find documentation regarding re-labeling of an FDA approved pharmaceutical topical anesthetic?

Please let me know where I can find documentation regarding this matter if possible.

Thank you!
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
If you were asking about medical devices, it would be easy to explain the difference between manufacturer-->distributor, manufacturer-->relabeler, and contract-manufacturer-->specification developer/marketer.

Pharma is kind of like devices in that regard. I think what you want to do is essentially the manufacturer-->relabeler model. But, the requirement for shipment pedigree and the pharma-only use of the Authorized Distributor of Record concept means that you need pharma-specific guidance.
 
A

azaplas

#5
Hi,

Thanks for your responses.

http://www.fda.gov/cder/drls/default.htm
On the 4th bullet on the left it shows a grid of the different types of requirements for the type of relabeler/etc.

Can anyone confirm with me that my company would be a "Own Label Relabeler [including recirculizer]"?
In this case we would be designing our own label and putting the new label on ourselves?

9 bullets down is Form 2658. If I have the manufacturer who makes the drug put our label on it, could I have the other company file under Form 2658, and then my company wouldn't need to register with the FDA?


Thanks!
 
M

MIREGMGR

#6
Caveat: I'm not authoritative regarding pharma.

***

My understanding is that if you choose the "own label relabeler" route, the other firm then would be a "contract manufacturer" in regard to their contractural relationship with you. They would apply labels per your specification. You would have to register your establishment and list the products you were marketing, noting that they are made for you by a contract manufacturer. Their regulatory clearances would apply. Only your identification would be on your product label.

If you choose the "own/private label distributor" route, the other firm then would be the "manufacturer". They would apply labels per a cooperatively determined specification. You could choose to register your establishment and list your products, noting that you are a distributor and noting the manufacturer, or (if the manufacturer agreed) you could choose not to register, in which case they would have to file a Form 2658 every six months regarding the business they do with you. They then would report your products on that 2658. Their regulatory clearances would apply. Your label would have to carry at least their identifying number, as the manufacturer.
 
Thread starter Similar threads Forum Replies Date
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
M How to Select FDA Medical Device Product Code? Other US Medical Device Regulations 10
Ronen E FDA News FDA's CDRH is silo-ing along product lines - CDRH Reorganization Medical Device and FDA Regulations and Standards News 4
Ed Panek Other company wants to use our FDA 510K bundled with their product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ajit Basrur FDA - Tobacco Registration and Product Listing US Food and Drug Administration (FDA) 2
H FDA product code and regulation number Other US Medical Device Regulations 3
I FDA Exempts Product Codes from 510(k) Process (Class II Medical Devices) US Food and Drug Administration (FDA) 0
F Development Meeting with the FDA - Approval Pathway for a Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D FDA Guidance Document for Preparing Annual Product Reviews US Food and Drug Administration (FDA) 2
B FDA Product Classification - Self Treatment Software Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Mexico: Paths to approval for product that is CE-marked, but not FDA approved? Other Medical Device Regulations World-Wide 2
A Beta Testing FDA Regulated Medical Device Software vs. Nonconforming product? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
thisby_ FDA, IEC 60601-1 and IEC 60601-1-2 - Registration of similar product US Food and Drug Administration (FDA) 3
S New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Reporting Other US Medical Device Regulations 15
M FDA Warning Letter - Product Association with Search Engine Results - Problems Ahead? US Food and Drug Administration (FDA) 10
E FDA and ISO 13485 - Once we get our 510K are we free to sell product? US Food and Drug Administration (FDA) 2
G How do I change the Medical Device Product Code in FDA site? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J FDA Annual Product Review (APR) Requirements US Food and Drug Administration (FDA) 1
A FDA "Product Code" Classification Basics US Food and Drug Administration (FDA) 8
A Question about FDA 21 CFR Part 820.90 Nonconforming Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
E AQL Level Change for FDA Validated Unclassified Dental Product Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
W FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the FDA Other US Medical Device Regulations 5
M FDA Product Review Committee US Food and Drug Administration (FDA) 1
I IVD product for use in a Drug Clinical Trial (FDA matters) US Food and Drug Administration (FDA) 3
G How to determine FDA Product Performance Requirement US Food and Drug Administration (FDA) 5
L Medical Device FDA Product Classification help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N OTC (Over The Counter) Product FDA Label Change Requirements US Food and Drug Administration (FDA) 2
E FDA New Product Introduction Regulations help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site US Food and Drug Administration (FDA) 2
Michael Malis The FDA proposes to amend the combination product regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P FDA Application for a Class IIa CE Marked Product bought from another company US Food and Drug Administration (FDA) 2
bio_subbu US FDA Proposed Rule for Combination Product Reporting US Food and Drug Administration (FDA) 1
J FDA Packaging Test Requirements - Product is PE Bag 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Healthcare Canada vs. FDA - Differences in obtaining approval to sell product Canada Medical Device Regulations 2
A Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
G I need help regarding product responsibility in relationship to FDA ISO 13485:2016 - Medical Device Quality Management Systems 3
P FDA requires 7 Years of Support? UL 544 for Extended Support? End of Life of Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5

Similar threads

Top Bottom