GS1

GS1 Ratifies Updated Versions of EPCIS and CBV

May 22, 2014 Dirk Rodgers

GS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday. Both carry the new version number “1.1”. The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.

This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).

WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN

This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV →

DSCSA

The Differences Between The DSCSA, FDA Rules and Guidance

May 21, 2014 Dirk Rodgers 2 Comments

From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA). It appears that some people might be confusing these a little.

Dr. Connie Jung, RPh, PhD, Acting Associate Director of Policy and Communications, in the Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research, helped put it all into perspective for me. During one of the breaks at the recent FDA DSCSA Workshop (see “The 2014 FDA DSCSA Workshop“) I asked Dr. Jung what the odds are Continue reading The Differences Between The DSCSA, FDA Rules and Guidance →

UDI

Requesting an Extension/Exception to the U.S. FDA UDI Rules

May 19, 2014 Dirk Rodgers

Are you behind in your preparations for the September 24, 2014 deadline for Unique Device Identification on class III medical devices (see “UDI Deadline For Class III Medical Devices Quickly Approaching”)? Do you need to apply for an 1-year extension of the compliance date for a class III medical device or a device licensed under the Public Health Service Act? Do you need to file an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device? Do you need to continue using an existing National Health Related Item Code (NHRIC) or National Drug Code (NDC) Labeler Code that was assigned to you by the FDA in the past (see “UDI And The Approaching End Of The NDC”)?

If you answered “yes”, or, “Uh…I think so”, to any of the questions above, then Continue reading Requesting an Extension/Exception to the U.S. FDA UDI Rules →

DSCSA, FDA

The 2014 FDA DSCSA Workshop

May 12, 2014 Dirk Rodgers

The U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD. The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS). The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft.

The workshop was held in a large room with eleven big tables, each with about 18 chairs around them. The FDA had Continue reading The 2014 FDA DSCSA Workshop →

UDI, Uncategorized

UDI Deadline For Class III Medical Devices Quickly Approaching

May 5, 2014 Dirk Rodgers

There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Data for these devices must be submitted to the Global Unique Device Identifier Database (GUDID). § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching →

DSCSA, HDMA

Just Released – The HDMA EDI ASN Guidance For DSCSA

April 30, 2014 Dirk Rodgers 3 Comments

NOTICE: The HDMA has updated this guideline again only a few months after this essay was published. Please see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” for additional information. — Dirk.

The Healthcare Distribution Management Association (HDMA) has just published their much anticipated new guidance on applying the Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN) transaction set toward compliance with the new U.S. Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA). HDMA members and non-members can download a copy of the new document here. Make sure you look for “HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA“. (See the image to the right.)

The new guidance is voluntary, like all HDMA guidance (see “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance” and “Updated HDMA Bar Code Guidance: A Must Read“), but companies who Continue reading Just Released – The HDMA EDI ASN Guidance For DSCSA →

Randomization

Randomization—An Interview with Ken Traub—Part 5: Other Approaches

April 30, 2014 Ken Traub

This is the last of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:

GS1 Serial Number Considerations
Properties of Randomization
Threat Analysis
Algorithmic Approach
Other Approaches to Randomization (this essay)

This week Ken talks about other approaches to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 5: Other Approaches →

Randomization

Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach

April 28, 2014 Ken Traub 3 Comments

This is the fourth installment of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:

In this installment, Ken explains the algorithmic approach to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach →

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