Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

This content was submitted directly to this website by the supplier.

May 21st, 2021

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

This guidance describes the Agency's policy regarding the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages set forth at 21 CFR 801.57(a)-(b).

As is described, FDA does not intend to object to the use of legacy FDA identification numbers on device labels and packages for finished devices manufactured and labeled prior to September 24, 2023.

In addition, this guidance addresses requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs).

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages Guidance for Industry and Food and Drug Administration Staff

For product traceability, outbound scanning alone is expected to increase labor by a minimum of 12 to 15% based on recent time studies, per Cardinal Health.

Will Labor Requirements Increase in Meeting DSCSA Milestones?

With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations.

Companies are adopting robotics and biometrics initiatives in drug product manufacturing and modern, robust aseptic processing technologies that afford tangible safety benefits to sterile products.

Applying Modern Technology to Pharmaceutical Production Facilities

Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods.

Hp 107536 Surgical Tools Copy png 2

EU Regulators, Recycling, and Healthcare Plastics

Packaging suppliers speak about the openness of regulators to understand the slower nature of life science manufacturers in adopting more sustainable packaging.

Screen Shot 2021 11 01 At 7 04 22 Am

HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization

With 2023 DSCSA requirements around the corner, findings reveal aggregation has slowed. Now in its sixth year, this survey, released as part of HDA’s Traceability Online Seminar (November 1–3), assesses industry abilities to meet DSCSA requirements.

Four DSCSA Guidances Were Released this Summer: Are You Up to Date?

Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.

Your CDMO Partner for Finished Products

Your CDMO Partner for Finished Products

When your development, manufacturing, packaging, quality, and delivery needs call for an all-inclusive partner, Sovereign Pharmaceuticals is here. We offer the highest quality contract manufacturing solutions.

Devices Getty Images 624567292 Sep Oct 2018

FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)

The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

As Marijuana Business Daily's Omar Sacirbey writes, “The move will allow greater research into marijuana and its potential medicinal properties.'

One Step Closer to Cannabis Access for Medical Research

After years of dragging their heels on approving marijuana cultivation applications for research, the DEA looks to be moving forward with licenses soon.

Expedite Med Device Approval with FDA’s New Program

Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.

Check out the links to our coverage of the 2021 PDA Annual Meeting. While the live event has passed, the event site is full of on-demand content covering pharmaceutical filling, supply chain considerations, vaccine manufacturing, and more through May 16.

2021 PDA Annual Meeting: Trend Roundup

The Parenteral Drug Association (PDA) virtual conference offered plenty of new perspectives in aseptic filling, flexible facilities, and more.

Your CDMO Partner for Finished Products

Your CDMO Partner for Finished Products

When your development, manufacturing, packaging, quality, and delivery needs call for an all-inclusive partner, Sovereign Pharmaceuticals is here. We offer the highest quality contract manufacturing solutions.

Hcp Title 60661e958299d

5 Tips To Improve Your Remote/Hybrid Audits

Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.

Pda Dk Blue Tag Below

PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs

Courses to cover many PDA areas of expertise, including aseptic processing.

Getty Images 488635873

PDA Post-Approval Change Issues and Impacts Survey

This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.

Getty Images 136641043

Serialization Continues to Impact Pharma Automation Investments

Automation and IoT are on trend, as the industry continues to meet serialization regulations.

Govzilla Announces New Customer Platform and Company Name Change to Redica Systems

Fda Hi Res Copy

Saleable Returns Verification Delayed to 2023

Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.

Gavel 5efd2dbada95c

Cannabis Policy Vote May Happen by End of 2020

The MORE Act would be historic in that it would remove cannabis from the Controlled Substances Act, opening a path for regulations to follow.

Alignment 90 Sep Oct 2018

Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)

The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.

More in Regulatory

Smithers tests med devices

Smithers, a leading provider of testing, consulting, information, and compliance services, has announced the formation of the Medical Device Testing division.

Med Devices and the FDA: Extended Deadline, Worker Safety

In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.

FDA Commissioner Dr. Stephen Hahn

New FDA Insight Podcast on Emerging Topics

First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.

Quick Hits: Allergan is Seeking Women with Recalled Breast Implants

Allergan recalled breast implants more than 10 months ago; now they are trying to find the women who still have them.

Fitbit Ventilator

Quick Hits: FDA Gives Emergency Approval to Fitbit’s Ventilator

The wearable tech company developed a new ventilator to help treat the current health crisis.

Getty Images 1127958533 Drug Prices

States Focus Legislation on Prescription Drug Costs

Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug prices—an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.

Getty Images 116406615

Take PDA's COVID-19 Survey in Pharmaceuticals

The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.

Honeywell Bigfinite Collaboration 300 Dpi

Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies

The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.

World Health Organization (WHO) declared the Wuhan coronavirus outbreak a global health emergency.

W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads

Most of the 8,000 cases have been reported in mainland China.

Feds Say Not Legal, But Still It’s Not Rare: Why’s CBD for Sale Everywhere?

In our column’s continuing effort to correct common misconceptions about packaging law, this month we turn to cannabidiol, or CBD.

Un Pac Ked Podcast Graphic

Cannabis Packaging: Don't Fear the Reefer

UnPACKed with PMMI Podcast breaks down the latest developments in cannabis packaging as more and more states open the door to legalization.

Controversial new labeling idea

Headlines from the U.K. sound promising but reading deeper reveals very little benefit for contemplating such a major change for food manufacturers.