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Get the free CMS LABELER CONTACT FILE RECORD FORMAT Effective ... - medicaid

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CMS LABELED CONTACT FILE RECORD FORMAT Effective: August 2009 Source: CMS Target: State Agencies Field Size Position Remarks Labeled Code Labeled Name Optional Eff. Date Termination Date Legal Contact
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How to Fill Out CMS Labeler Contact File:

01
Open the CMS Labeler Contact File form on your computer.
02
Enter the name of the labeler or company in the designated field.
03
Provide the contact person's name, job title, and contact information such as phone number and email address.
04
Indicate the address of the labeler's location, including street, city, state, and ZIP code.
05
Specify the labeler's national drug code (NDC), if applicable.
06
If the labeler is a distributor or repackager, include the necessary information such as NDCs or lot numbers.
07
Review the completed form for accuracy and completeness.
08
Save the CMS Labeler Contact File on your computer or submit it according to the instructions provided.

Who Needs CMS Labeler Contact File:

01
Pharmaceutical manufacturers: Companies involved in the production of drugs or pharmaceutical products must fill out the CMS Labeler Contact File. This ensures that they can be contacted for regulatory purposes, tracking, and other communication needs.
02
Distributors and repackagers: Entities involved in the distribution, repackaging, or relabeling of pharmaceutical products also need to complete the CMS Labeler Contact File. This information helps in maintaining accurate records and facilitates efficient communication within the supply chain.
03
Regulatory agencies and stakeholders: Government agencies, such as the Centers for Medicare & Medicaid Services (CMS), may require access to the CMS Labeler Contact File to ensure compliance and effective oversight of the pharmaceutical industry. Other stakeholders, such as healthcare providers and insurers, may also benefit from readily available contact information for labelers.
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CMS Labeler Contact File is a document that includes information about the contact details of the entity responsible for applying product labels.
The entity that is responsible for applying product labels is required to file the CMS Labeler Contact File.
The CMS Labeler Contact File can be filled out by providing the required contact information of the labeler entity as per the provided template.
The purpose of the CMS Labeler Contact File is to provide a means for regulatory authorities and other stakeholders to easily access the contact information of the labeler entity.
The CMS Labeler Contact File must include information such as the name of the labeler entity, contact person, phone number, email address, and physical address.
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