1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

FDA Proposal On 'Inordinate' Interstate Compounding Sparks State Oversight Debate

 
• By Joanne S. Eglovitch

The US FDA’s revised draft MOU on interstate compounding, which stipulates new controls to ensure that pharmacies do not ship an “inordinate” amount of drugs across state lines, needs strong state oversight and robust information collection to work, say some groups commenting on the agreement. Yet two members of Congress are challenging the MOU on the grounds that some states and state boards of pharmacy lack the regulatory authority to implement the agreement.

Pharmacistswithmortatandpestle_1200x675

A revised US Food and Drug Administration proposal to let more compounded drug products cross state lines has prompted new hand-wringing over how states will make sure compounding pharmacies do not engage in an "inordinate" amount of interstate activity.

US pharmaceutical industry and compounding pharmacy groups weighed in on FDA’s revised memorandum of understanding on interstate compounding. Respondents said that stronger state oversight is needed to ensure that compounding...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

More from Compliance

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.