FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products - FDA Law Blog

Read the full article: FDA Law Blog: FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the products in the United States.”"

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Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

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Too Little Reward For Quality - Drives Generic Injectable Shortages

Clinical Pharmacology & Therapeutics - Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages:

"Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments."

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Critical Shortage of Children's Leukemia Drug

It's very concerning and a shame that we even have this situation.

Critical Shortage of Children's Leukemia Drug - ABC News:

"Medication used to treat the most common form of childhood leukemia is in short supply, adding to the largest nationwide shortage of critical lifesaving hospital medications in nearly a decade.

All five pharmaceutical companies that make the injection drug methotrexate, which treats acute lymphoblastic leukemia by slowing the growth of cancer cells, have either slowed and stopped manufacturing of the drug, according to the U.S. Food and Drug Administration. The companies have cited high demand or manufacturing delays as reasons for the shortage.

If the shortage continues, physicians and pharmacists fear thousands of children will be left without lifesaving treatment."

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FDA Says Drug Shortages Raise Risk of Cancer Counterfeits

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Updated May 25, 2021

The original link broke.

You can still read more about this topic:

• FDA's Dear Doctor Letter: Re: Purchasing Medications from Foreign or Unlicensed Suppliers Could Result in Serious Harm to Patients; Counterfeit Altuzan Found in U.S. (PDF)
• Historical Information: FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs, 2012-2014 - FDA.gov

---  the original post follows below  ---

The FDA published this notice. Looks like drug shortages are opening doors for bad actors to take advantage of the situation.

FDA Notifies Health Care Providers about the Risks of Purchasing Unapproved Injectable Cancer Medications from Unlicensed Sources

Current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States (U.S.).

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Nizoral Shampoo Available Again - I'm thrilled!

Woo-hoo!  After a very long wait, Nizoral Shampoo is back on store shelves.

The manufacturer has been is blaming a switch in manufacturing facilities.

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Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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