FDA Considers Compounding Industry User Fees

Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry:

Hamburg said in her blog posting that FDA "looks forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings."

Such funding might be able to bridge the gap between agency goals and resource limitations. Left unclear, however, is whether the pharmaceutical compounding industry would be on board with the proposal. Past user fee proposals, such as the Prescription Drug User Fee Act, the Medical Device User Fee Act and the Generic Drug User Fee Act have all been passed with the explicit support of their respective industries.

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Hamburg Says FDA Needs New Authorities to Regulate Pharmacy Compounding

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Updated April 19, 2022

The original post didn't age well.

You can read more here:

• Compounding and the FDA: Questions and Answers - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

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FDA Must Have New Authorities to Regulate Pharmacy Compounding | FDA Voice:

"In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including . . .

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include . . ."

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New Framework:

• Require compliance with federal quality standards, appropriate for the compounding of riskier products & exposure of larger numbers of patients,
• Require federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making.
• Require those higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware.

Basic Protections:

• Grant clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law.
• Prohibit compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. 

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Rotech Files Bankruptcy

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Rotech to file for bankruptcy | HME News:

"“After careful planning and consideration, we are pleased to have reached this major milestone of substantially reducing our debt,” stated President and CEO Steven Alsene in a release. “The company has struggled for years under the debt burden placed on it when it was spin off from its former parent company in 2002. Since that time, dramatic reimbursement reductions have made it essential that we reduce our debt to a manageable level.”"

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You might also be interested in:  Rotech Healthcare - About Us

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FDA Focus On cGMP Compliance By Compounders

Updated June 10, 2022

Some of the links broke.

You might also be interested in:

• Compounding Oversight and Compliance Actions - FDA.gov
• Human Drug Compounding - FDA.gov

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The FDA continues to focus on pharmacy compounders.

This is evidenced by the growing number of the FDA's Form 483s (Inspectional Observations) that are being posted:  FDA - 2013 Pharmacy Inspections

Earlier this month, the FDA sent a "Warning Letter" to Medi-Fare Drug and Home Health Center 3/7/13.  It highlights the myriad touchpoint issues, including pharmacy regulations, and the FDA's regulations on current good manufacturing practices (i.e., the FDA's cGMPs).

You might also be interested in:
21 CFR 211: Pure, Safe, and Effective - Online training - An orientation to the FDA's cGMPs

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"The Politic" Interviews Margaret Hamburg (FDA)

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The Woman in Charge: Margaret Hamburg | The Politic:

". . . The Politic: Let’s move on to the recent meningitis outbreak. Was the FDA in this case supposed to have prevented the outbreak, or was the role of the FDA more in the response portion?

Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern. I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one.

As a public health official and the head of the FDA, I would really like to be able to see a system that could help us prevent this type of tragedy going forward. As we've seen the industry and healthcare system evolve, I think what has always been a concern about a lack of clarity between state and federal responsibilities has gotten more pronounced and more dangerous. More and more health care systems are relying on sort of hybrid  compounding pharmacy/manufacturer in order to produce products they need. These facilities are in a gray area in between state and FDA regulations. . . . "

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FDA - 2013 Pharmacy Inspections - Form 483 Observations

The FDA is posting their observations, via Form 483, of pharmacies that they've inspected re: compounding.

ORA FOIA Electronic Reading Room > 2013 Pharmacy Inspections:

"2013 Pharmacy Inspections"

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Related articles

• High-Risk Compounding Pharmacies Targeted for FDA Review - Bloomberg
• FDA: Problems found at another facility of sister company of pharmacy tied to meningitis