07
Jun

Compounding Committee to Evaluate Addition of 4 New Ingredients

The FDA’s Pharmacy Compounding Advisory Committee will be considering the addition of four new ingredients for use for inclusion on the bulk list for 503A compounders to utilize in the compounding of prescription drug products.  The four ingredients up for consideration are: Ammonium tetrathiomolybdate; Enclomiphene citrate; Ferric subsulfate; and Glutathione The Notice for the Advisory […]

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06
Jun

FDA Withdraws Covid Q&A Document as the FDA Returns to a Semblance of Normalcy

In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]

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06
Jun

April Showers Did Bring May Flowers! A Look at the May Unofficial Approvals

The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals.  While not an all-time high for a single month, it is a welcome […]

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25
May

Importing Drugs by State, Indian Tribe, U.S. Pharmacist or Wholesaler? Here are Some Q&As You Will Need To Know

Now, HERE is a Q&A document that makes the how, who, why, and when very clear.  This Q&A final guidance outlines responses to a question that the Agency has fielded since the final rule regarding importation of prescription drugs went into effect on November 30, 2020. Of importance, this rule does not cover individual personal […]

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19
May

Have Some Time?  Read FDA’s Expectations on How to Assure Drug Product Labeling Is Safe!

You may need some time to read this recently published guidance entitled, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (here), as it is 41 pages long. There is lots of good information contained in the document and, while it may contain most of what you know about labeling requirements, […]

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19
May

Revised Approval Totals – What a Difference a Day Makes!

Surprise, surprise!  Just yesterday, we reported an anemic number of approvals through May 16th and today we were surprised to see (perhaps due to a fix to the FDA’s posting problem!) the new and now revised total through May 17th is thirty‑seven full‑approval actions (only one of which was approved on the 17th) and still one tentative […]

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