Data Sharing Required for Pharmacies; EU Track and Trace Ahead of US

Did you know, that the FDA begins its planning period for interoperable data exchange standards in 2018? So what does this look like... We can learn from Europe. In Europe, there are two specific supply chain security directives the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR) that have manufacturers, wholesalers and pharmacies actively working on DSCSA-like processes and technology. FMD/EUDR require submission of [...]

DSCSA in 2016: What you should be doing at this point

DSCSA regulations came into full force in March of 2016 for dispensers (e.g., pharmacies, clinics, and hospitals). At this point, you should have certain systems, processes and policies in place to comply with these federal regulations. Many, however, have put off compliance measures, for various reasons. Most are relying on wholesale distributors to store T3 documentation for them. Others have literally no idea what DSCSA is, let alone how [...]

Understanding the GS1 Standard Data Matrix Barcode

DSCSA product serialization becomes effective for manufacturers in 2017, Repackagers in 2018, Wholesalers in 2019, and Dispensers in 2020. So what exactly is different about the barcodes we currently have in supply chain, versus what we soon will have in supply chain. The major difference is a standard of "symbology", unifying to a data matrix standard for US marketed products AND a requirement, to encode [...]

What about 340B?

The 340B program, presents a unique set of questions and workflow considerations. 340B inventory in the contract pharmacy scenario is purchased by a covered entity such as a hospital or FQHC, and shipped to a 340B contract pharmacy. There are several considerations regarding DSCSA that you should consider. First, DSCSA does not make any exemptions at this time for 340B program participants or inventory purchased [...]

Breaking Down the T3 Document

The T3 document, contains 3 specific parts. T3 documents can be paper-generated or electronic. Below, we have broken down the essentials of the T3 document, as prescribed in DSCSA regulations. You can also view a sample document by clicking the button below. Transaction Information Detailed Information about the product such as identifier and to and from addresses. Transaction information must include: (A) the proprietary or [...]

DSCSA Track and Trace Exemptions

So what products are included under the umbrella of DSCSA? This is a question we are often asked by our clients, particularly when a product is received without T3 documentation.  This article should quickly summarize for you what the key terms and the categories of drugs that are excluded (exempt) from DSCSA tracking requirements. Two Key Terms: Product and Transaction The two key terms you [...]

DSCSA 2017 Product Serialization

 Ten Year Enhanced System The Drug Supply Chain Security Act (DSCSA), otherwise known as track and trace, is a series of regulatory changes impacting manufacturers, buyers, and sellers of prescription drug in the US marketplace. The overarching goal of DSCSA is to provide greater control and visibility throughout the drug supply chain, from original manufacturer to consumer. The purpose of this regulation is multi-fold, [...]

DSCSA Quick Facts

What is DSCSA? DSCSA stands for the Drug Supply Chain Security Act. Under this regulation, drugs you use in your clinic, hospital, or pharmacy are subject to new tracking requirements by the FDA. This in part is in response to the NECC meningitis outbreak in 2012. DSCSA is a part of a larger regulation signed into law in 2013, the Drug Quality and Security Act [...]

DSCSA Compliance Checklist

General My staff are fully aware of what DSCSA is, and they are routinely educated on how we comply from an operational perspective. I have an organization or corporate-level policy and procedure outlining DSCSA regulations. I routinely (at least semi-annually), self-audit my compliance with DSCSA regulations. I have had an independent audit of my organization for DSCSA compliance in the past [...]