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.

Supply Chain 52

Supply Chain Manufacturing IT Provider 52

FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA).

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

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.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law Blog

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The Rule, if enacted in its current form, will have sweeping implications throughout the supply chain, but particularly for WDDs and 3PLs. By Karla L.

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

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).

Management 45

Management Manufacturing Supply Chain Provider 45

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. HPM Counsel John W.M.

Supply Chain 66

Supply Chain Management IT Manufacturing 66

FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” Emphasis added.)

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

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.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

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.

Supply Chain 52

Supply Chain Illness Families Family 52

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.”

Supply Chain 69

Supply Chain Manufacturing Government Provider 69

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).

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59

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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98