Compliance

02
May

Another Unapproved Drug a Slap in the Face

FDA has warned consumers not to use two products containing ammonia chloride, “Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy.” The Agency says, “Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction” and it “has received reports of adverse events […]

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05
Apr

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020.  As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]

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05
Apr

503B Outsourcing Facilities Batting 1 for 11 in This Round of Bulk Substances Reviewed

The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]

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16
Mar

FDA Issues Draft Guidance with Definitions of Terms in Drug Supply Chain Security Act (DSCSA)

Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here).  The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]

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07
Mar

FDA Announces Dietary Supplement List

In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them.  This is a confusing area for the […]

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24
Feb

Discontinued Chantix – FDA Says Not for S&E Reasons

When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]

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15
Feb

Is Your Supply Chain at Risk?

Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines?  This could be a difficult self-reflection for weak supply chains, devastated by the pandemic.  The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply […]

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