News & Analysis as of

Drug Compounding

United States Intervenes in Suit Against Private Equity Firm Based on Health Care Portfolio Company's Alleged False Claims Act...

• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more

Health Care Investors Beware: U.S. Attorney Sues Private Equity Firm For Portfolio Company’s Alleged Billing Fraud

The U.S. Attorney for the Southern District of Florida has recently decided to intervene in a lawsuit brought under the Federal False Claims Act and initiated by a whistleblower. The U.S. Attorney has filed his own...more

The Effect of the DOJ Memo, "Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases," On FDA Inspections...

by Reed Smith on

For years, the Food and Drug Administration (FDA) has relied upon draft and final guidance policies as the basis of Form 483 inspectional observations. A recent memorandum issued on January 25, 2018 by the Attorney General...more

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more

Capitol Hill Healthcare Update

by BakerHostetler on

After a tumultuous year on Capitol Hill – with repeated efforts to repeal the Affordable Care Act and stalled attempts to renew the Children’s Health Insurance Program – President Donald Trump isn’t likely to focus on...more

FDA Continues to Prioritize Compounding Regulation with the 2018 Compounding Policy Priorities Plan

by Reed Smith on

On January 19, 2018, FDA Commissioner Scott Gottlieb, M.D. released FDA’s 2018 Compounding Policy Priorities Plan. The plan provides an overview of the key priorities FDA will pursue in 2018 to implement the federal law on...more

IP considerations in the early stages of drug development – how to pick your moment

by FPA Patent Attorneys on

The step of identifying an initial lead drug candidate is the cornerstone of the drug development process and is also usually the point at which actions are taken to protect the associated intellectual property (IP). However,...more

FDA Withdraws Draft Guidance For Industry #230

by Reed Smith on

The U.S. Food & Drug Administration (“FDA”) announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.”...more

Big Issues Front and Center at Annual Conference for the American Society for Pharmacy Law

by Faegre Baker Daniels on

In the midst of the opioid epidemic, pharmacists and attorneys from across the country gathered last week for the 28th Annual Conference for the American Society for Pharmacy Law (ASPL). The conference brought together...more

Shortage of Relief: Recent Disasters Highlight Multifaceted Drug Shortage Problem

by Holland & Knight LLP on

• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more

FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders

by Reed Smith on

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of...more

Compounding Pharmacies Should Expect Greater Scrutiny as Government Healthcare Budgets Get Squeezed

by Blank Rome LLP on

As Congress continues to grapple over healthcare reform, there are many uncertainties. However, one thing is clear: as government healthcare funding shrinks, federal and state enforcement agencies will continue to target...more

Comparative Fault of Government Regulators Might be a Defense

by Reed Smith on

‘Pointing to the empty chair’ is a well-known defense trial tactic. It allows the defendant to go on offense. Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party. ...more

Human Drug Compounding: FDA Issues Four Guidance Documents

by BakerHostetler on

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more

Compounding Pharmacy’s Group Boycott Claim Survives Motion to Dismiss

On August 23, 2016, the District Court for the Eastern District of Missouri allowed claims by a compounding pharmacy to proceed, denying a motion to dismiss filed by the defendant pharmacy benefit manager (“PBM”). In...more

AGG Food and Drug Newsletter - July 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”

by Arnall Golden Gregory LLP on

Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more

Ask the Public Adjustor: Covering Life with Wisdom*

by Pullman & Comley, LLC on

I’ll come right out and admit it: I was a crasher at last night’s party. Though they helped me bluff my way in, every stitch of clothing I wore was borrowed, and the limo … it’s a long story, but let’s just say Uber. Then I...more

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound...more

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

by Polsinelli on

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

FDA Issues Three Draft Guidance Documents For Drug Compounders

by King & Spalding on

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing... - FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

by McGuireWoods LLP on

The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

Fireworks for Animal Compounding and More at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part...

by McGuireWoods LLP on

On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more

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