Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

As per the final rule published on 08/30/2016 (see below link), private label distributors do not have an obligation to register their establishment or list drugs on Daily Med as they do not manufacture, repack or relabels drugs. So in this case store brands of medicines like Aspirin would not have to list their products.

Having said that, does the repacker, relabeler who creates that product for them (Private Label Distributor) have an obligation to submit drug listing on their behalf?

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs

Federal Register		remove preview
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs Food and Drug Administration, HHS. Final rule. The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. View this on Federal Register >

"​The establishment registration and listing obligation rests with persons who manufacture, repack, relabel, or salvage drug products. The rule does not require persons who act only as private label distributors of drug products to register establishments or list drugs, but allows them to submit drug listing information as agents acting on behalf of persons who manufacture, repack, relabel, or salvage drug products."

Regards,
Gary Saner
gsaner@reedtech.com, www.Reedtech.com  

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Gary Saner
Sr Mgr Information Solutions Life Sciences
Reed Technology
Horsham PA
United States
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Original Message:
Sent: 25-Oct-2017 10:34
From: Anonymous Member
Subject: NDC listing requirements for private label distributors

This message was posted by a user wishing to remain anonymous

Hello All,

As per the final rule published on 08/30/2016 (see below link), private label distributors do not have an obligation to register their establishment or list drugs on Daily Med as they do not manufacture, repack or relabels drugs. So in this case store brands of medicines like Aspirin would not have to list their products.

Having said that, does the repacker, relabeler who creates that product for them (Private Label Distributor) have an obligation to submit drug listing on their behalf?

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs

Federal Register		remove preview
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs Food and Drug Administration, HHS. Final rule. The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. View this on Federal Register >