Compliance

17
Apr

Another Histamine H2 Receptor Antagonist Implicated in the NDMA Impurity Saga

The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]

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10
Apr

Agency Provides Guidance on Mask Shortage in Sterile Compounding Pharmacies

If you are not registered as an outsourcing compounder but are a pharmacy/hospital-based compounder of sterile products, FDA has provided advice for you if the garb that you need (including masks and gloves) are in short supply.  The document does not detail outlining the steps that such compounders can take help assure the sterility and […]

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08
Apr
flying money

Out of Sight – Out of Mind – Not Hardly and No Refunds

FDA issues Guidance for Industry: “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, April 2020”. With all that’s going on with Covid-19, FDA is diligently executing their priorities for this fiscal year.  In FY19, FDA’s priorities for Compounding (human drugs) were to: maintain quality manufacturing and compliance; […]

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07
Apr
world map, creative abstract design background photo

How Do Bad Facts Become Fake News and Possibly Worse?

Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction.  Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S.  While bringing jobs back to the […]

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07
Apr

In Case You Did Not Know – Lachman Consultants Offers Remote Training Options

Training of employees remains a hallmark of the industry’s ability to deliver high quality medicines, devices, and diagnostics.  Training is a crucial activity, now, more than ever, in this rapidly changing environment. During this period of social distancing, when the experts cannot travel to your site to perform training, that does not mean that this […]

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02
Apr

Ranitidine Market Withdrawal Mandated by FDA

These days, everybody’s attention is focused is focused on COVID-19.  However, that does not mean that the issues that the FDA was struggling with prior to the pandemic have disappeared.  In fact, some rather major news regarding nitrosamine impurities was announced by the FDA yesterday (and it wasn’t an April Fools’ Day stunt!). Yesterday, the […]

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01
Apr

Lachman Reach-Out to New Hand Sanitizer Producers in Support of the COVID-19 Effort

Lachman Consultants is reaching out to U.S. distilleries and fermenters to provide support and guidance for the manufacture of hand sanitizers.  In response to several phone calls from industries wanting to help in the COVID-19 efforts, Lachman is responding with an interpretation of the most recent guidance from the U.S. Food and Drug Administration (here […]

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31
Mar
Caution Tape

FDA Promotes Hydroxychloroquine to Category 1 Status for Compounders – Wait a Minute!

My eyes almost popped out of my head when I read this article (here) concerning FDA’s move to place hydroxychloroquine in Category 1 for use by compounders based on a potential drug shortage created mostly by the administration’s hope that the drug may have some effect on COVID 19.  It is one thing to use […]

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18
Mar

Mission Critical Only Inspections Starting on March 19

On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]

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21
Feb
Colored skittles with different sizes

Less is More!

Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA).  Specifically, the […]

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