$129.99
Stay ahead of regulatory changes with this essential course on the FDA’s new requirements for standardizing the National Drug Code (NDC) to a 12-digit, three-segment format. Learn how to implement updated barcode label standards and ensure your product labels are compliant with current FDA regulations. Discover the practical steps for manufacturers, relabelers, and distributors to meet new deadlines, avoid costly penalties, and maintain seamless market access. Includes actionable guidance on electronic submission, recordkeeping, and registration procedures.
In this course you will learn the following:
* Understand the scope and intent of the final rule.
* Identify key compliance requirements for drug and biological product labeling and registration.
* Implement actionable steps to meet new regulatory obligations and deadlines.
* Recognize the legal and financial consequences of non-compliance.
* Locate resources and FDA contacts for further guidance.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Why This Course is Important
Without this training, your organization risks costly non-compliance, potential product recalls, regulatory penalties, and disruption in market access due to outdated NDC formats and labeling standards.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Revising the National Drug Code Format and Drug Label Barcode Requirements.
Key regulatory references include:
Course SKU
FR-26-1778-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment. Document Number: 2026-11526
Buy this Course
FR-26-1987-1
Why This Course is Important
Without this course, practitioners risk non-compliance with updated DEA rules, potential loss of prescribing privileges, audit failures, and exposure to significant legal and financial penalties.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment.
Key regulatory references include:
Course SKU
FR-26-1987-1
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