Over-the-Counter Sales

News & Analysis as of

FDA Drops 19 Ingredients From the OTC Antibacterial Monograph: Antibacterial and Hand Soap Manufacturers Have One Year to Comply.

On September 6, 2016, the Food and Drug Administration (FDA) published a final rule on the use of certain active ingredients which were proposed for inclusion in the Over-The-Counter (OTC) Consumer antiseptic washes portion...more

California Federal Court Holds That U.S. Securities Laws Do Not Apply to Unsponsored, Unlisted ADRs

The U.S. District Court for the Central District of California held on May 20, 2016 that the federal securities laws do not apply to U.S. transactions in unlisted, unsponsored American Depositary Receipts (ADRs) for a foreign...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

More Money May Be in Store for Distilleries

More favorable changes may be in store for distilleries that want to sell bottles on-premise to consumers in North Carolina. Proposed new North Carolina legislation would (1) expand the number of distilleries that can sell...more

Hedging Oil & Gas Production

The recent, dramatic decline in the price of oil illustrates the risk that every oil and gas producer has to declining energy commodity prices. This paper discusses various methods for “hedging” or reducing price risk. In...more

SEC Remarks at the Practising Law Institute’s Program Titled “SEC Speaks in 2015”

On February 20, 2015, several representatives from the SEC spoke at the Practising Law Institute’s program titled “SEC Speaks in 2015,” including Chair Mary Jo White and Commissioner Louis A. Aguilar. Ms. White provided...more

Additional Two-Year Clearing Reprieve for European Pension Schemes

The European Commission (EC) has proposed a further two-year extension beyond the three-year exemption from mandatory clearing of over-the-counter derivatives granted to qualifying pension scheme arrangements (PSAs) under...more

OTC Derivatives Regulators Issue Report Regarding Cross-Border Issues

On September 10, the Over-the-Counter Derivatives Regulators Group (ODRG) issued a report providing an update to the Group of 20 (G20) on its progress in resolving over-the-counter (OTC) derivatives cross-border...more

IOSCO Launches Public Information Repository for Central Clearing Requirements

On August 5, IOSCO unveiled its new information repository for central clearing requirements relating to over the counter derivatives....more

ERISA (8th Circuit): Over-The-Counter Vitamin Supplements Trigger Pre-Existing Condition Exclusion

What sort of “medical treatment” triggers the pre-existing condition exclusion in an ERISA-governed disability policy?...more

FINRA Proposes to Adopt Rules on Quotation Requirements for OTC Equity Securities

The Financial Industry Regulatory Authority, Inc. is proposing to adopt rules governing the quotation requirements applicable to over-the-counter (OTC) equity securities. The rules would establish minimum standards for...more

Microcap Fraud: An FBI Controlled Shell Company

Five men came together to plan the manipulation of an over-the-counter traded shell. What they did not know was that the shell was controlled by the FBI. SEC v. Affa, Civil Action No. 1:14-cv-12959 (D. Mass. Filed July 11,...more

Planes, trains and Over-the-Counter pills

This Reed Smith client alert looks at the recent amendments to the Human Medicines Regulations 2012, which came into force in November 2013....more

Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more

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