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. Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. What if baby formula is out of stock everywhere I look?

Supply Chain 52

Supply Chain Specialization IT Family Medicine 52

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.

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

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.

Supply Chain 52

Supply Chain Manufacturing IT Provider 52

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.

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

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. Dialogue is also key.

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Supply Chain Management Manufacturing IT 66

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). Proposed Rule at 30.

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

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

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

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.)

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

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.

Supply Chain 75

Supply Chain Manufacturing Engineering Consulting 75

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.”

Supply Chain 52

Supply Chain Government Insurance Manufacturing 52

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. More Steps Ahead As the SIP sponsor, Florida will be responsible for implementing the program.

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. Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98