FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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My Green Doctor

MAY 3, 2025

Single use has become the custom for most clinicians and managers, just as disposable products have become prevalent across the medical supply chain. The product manufacturers and vendors will need to be active partners as well. 4 Changing to multiuse bottles will be challenging. The use of medications in U.S.

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FDA Law Blog

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.

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FDA Law Blog

JULY 18, 2023

The report reiterated a commitment to maintain the supply chain and provides more context about how OPQ—and FDA, more generally—are approaching quality and enforcement as we continue to hurtle past the COVID-19 public health emergency (PHE). That leaves 60% that manufacture at least one application product. and South Korea.

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FDA Law Blog

OCTOBER 12, 2022

Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA). It may not be clear to supply chain stakeholders which entities may be considered “harm reduction programs” for the purposes of this Guidance.

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Current shortages have been largely caused by supply chain issues and the recent recall of several baby formula products over concerns about contamination. Always mix formula as directed by the manufacturer. Always follow label instructions or those given to you by your pediatrician. Can I make my own baby formula?

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FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. See our previous coverage of such state laws here , here and here.) North Dakota.

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FDA Law Blog

FEBRUARY 4, 2022

The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within two years of its enactment (i.e., The comment period for the Proposed Rule will remain open until June 4, 2022 (120 days after publication).

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FDA Law Blog

FEBRUARY 26, 2025

How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands? M&A rises and falls on due diligence along with other factors like market conditions and growth opportunities, so compliance and quality are vital links in any deal chain.

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FDA Law Blog

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

MARCH 27, 2023

Legacy FDA identification numbers refer to both National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers created using labeler codes previously assigned to device manufacturers by FDA. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” Emphasis added.)

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FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

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FDA Law Blog

NOVEMBER 22, 2022

But as noted above, identifying points in the food supply chain, the source of the product, and where contamination may have occurred can be a long and difficult process. What information firms must maintain and share under the rule depends on the type of activities they perform in the supply chain with respect to an FTL food.

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FDA Law Blog

JANUARY 24, 2024

Karst — In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order— Executive Order 14081 —titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”

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FDA Law Blog

SEPTEMBER 16, 2022

The Executive Order was spurred in part by the COVID-19 pandemic, but it points out that biotechnology and biomanufacturing—defined as use of biological systems to develop products, tools, and processes at commercial scale—has other uses outside of human health, including securing supply chains and growing the American economy.

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FDA Law Blog

JULY 12, 2021

The Secretary of Health and Human Services is directed to submit to the White House, by August 23, a plan to “combat excessive pricing of prescription drugs and enhance domestic pharmaceutical supply chains, to reduce pries paid by the Federal Government for such drugs, and to address the recurrent problem of price gouging.”

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FDA Law Blog

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c).

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FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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