Supply Chain

News & Analysis as of

FDA Releases Draft Guidance on its Voluntary Qualified Importer Program

On June 5, 2015, the Food and Drug Administration (FDA) announced the publication of its Draft Guidance on its Voluntary Qualified Importer Program (VQIP). The FDA is establishing VQIP to enable the expedited review and...more

FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more

FDA Announced a Four-Month Enforcement Delay on Certain Drug Supply Chain Security Act Product Tracing Requirements for Dispensers

FDA Does Not Intend to Enforce Product Tracing Requirements Related to Dispensers’ Receipt and Maintenance of Product Tracing Information Until November 1, 2015. It Did Not Delay Dispenser Requirements With Respect to Product...more

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

Conflict Minerals: European Parliament Endorses New Compliance Requirements

It has been nearly a month since the deadline for companies in the United States to file their second annual conflict minerals reports with the Securities and Exchange Commission. As companies and their stakeholders assess...more

Goods and Services Tax in Australia to Apply to Offshore Digital Supplies (and More)

Draft Goods and Services Tax (GST) legislation has been released which seeks to level the playing field by ensuring that digital products and services provided to Australian consumers are subject to GST, whether provided by...more

Modern Slavery Act - Preparing For Greater Supply Chain Transparency

In this news letter: - Preparing for greater supply chain transparency - Background - Timing - Will you be affected? - Preparing the statement - How far up your supply...more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

Fraud and the Detection of the Sources for Bribery

In a recent White Paper authored by Peter Smith for OFS Portal, entitled “Procurement and Fraud in the Supply Chain”, where he examined “fraud linked to procurement and supply chain activities.” Smith focuses on where fraud...more

FCPA Compliance and Ethics Report-Episode 169-the First Mailbag Issue [Video]

In this inaugural Mailbag Episode, I field questions from an earlier podcast on the training of third parties under the FCPA. ...more

G7 Leaders Issue Declaration Supporting Private Sector Implementation of Human Rights Due Diligence

At the conclusion of the G7 Summit held on June 7 and 8, the assembled leaders released a declaration endorsing the U.N. Guiding Principles on Business and Human Rights. Specifically, leaders of the United States, the United...more

California Department of Justice Seeking Information on California Transparency in Supply Chains Act Compliance

The California Department of Justice is sending companies informational letters regarding their compliance with the California Transparency in Supply Chains Act....more

Taking Your Business International

Going international is a complicated undertaking. The steps required will depend on your specific situation and concerns. The following outlines, in very general terms, some of the issues you must consider as you begin to...more

The Trade Agreements Act: An Unknown Compliance Issue for Small Businesses

Small businesses often enter into government contracts unaware of all the laws and regulations that may apply when selling to the government. One of the laws that is often overlooked is the Trade Agreement Act (TAA). ...more

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more

The California Transparency in Supply Chains Act: New Guidance and Increased Enforcement Efforts

The State of California has recently stepped up enforcement of the California Transparency in Supply Chains Act, which went into effect on January 1, 2012. The California Department of Justice has also issued new guidance on...more

Reinventing Compliance Program Metrics

One of many pet peeves I have in the compliance space is the lack of creativity in compliance program measurement. Chief Compliance Officers have to take a fresh approach to this issue....more

New reporting requirements for employment intermediaries

HM Revenue & Customs (HMRC) continues to strive to reduce the number of workers not subject to PAYE. It has added new reporting requirements for businesses that it considers to be ‘employment intermediaries’. Care is now...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

A Non-Insider Trading Case in the District of Massachusetts

Insider trading prosecutions can be difficult. Because of the haphazard and tortuous growth of insider trading law itself, the prosecutions involve proving lots of different pesky elements. Fiduciary duties, materiality,...more

California AG Asks Retailers And Manufacturers To Report On Supply Chains Act Compliance

The California Attorney General’s office recently sent letters to retailers and manufacturers asking them to demonstrate compliance with the California Transparency in Supply Chains Act or why they are not subject to the act....more

Buying Someone Else's Headache – Top Five Supply Chain Pitfalls to Consider When Expanding Through Acquisition

As the economic recovery continues to pick up steam, manufacturers are looking to grow their capacity and expand their markets. Many manufacturers choose to expand their horizons by acquiring smaller companies or merging with...more

Managing Your Third Parties in a FCPA Compliance Program

The building blocks of any Foreign Corrupt Practices Act (FCPA) anti-corruption compliance program lay the foundations for a best practices compliance program. For instance in the lifecycle management of third parties, most...more

Supply Chain as a Source of Compliance Innovation

On this day we celebrate the greatest upset in the history of the NCAA Basketball Tournament, when Villanova beat Georgetown for the 1985 national championship. Georgetown was the defending national champion and had beaten...more

Effective cybersecurity: 8 questions for you and your team

Cybersecurity has become a top-tier risk for US and multinational organizations. It is only a matter of time before a determined hacker will penetrate your organization’s system and successfully exfiltrate some data. (Indeed,...more

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