As mentioned last week, here is the flow-diagram for determining whether or not the FDA considers a drug to be "commercially available".

Recall from last week's Newsletter, the interpretation of the statement "regularly or in inordinate amounts":

The FDA interprets this to mean that a drug product that is essentially a copy of a commercially available drug product cannot be compounded regularly (i.e., it cannot be compounded at regular times or intervals, usually, or very often. Please review last week's newsletter for more details.

The FDA does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions for the relevant compounded drug product in a calendar month.

Please obtain a complete copy of this Guidance at URL below and check all of this out.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM510154.pdf

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know ...

�that it seems the "media" is not interested in "reporting the news" but instead wants to "give their opinion on the news," along with partial stories and misrepresentations?

Tip of the Week

I don't know about you but when I want the news, I DO NOT WANT SOMEONE'S OPINION of what is happening, especially if only a part of the story is told so they can support their own agenda.

It seems the media (notice it is not the "news media") has taken it upon themselves to no longer be "truthful or even investigative" in nature but to be "accusative" in content and tone and to even fabricate stories and issues.

I often think of Jack Webb (Sargent Friday) of Dragnet when he said "Just the facts ma'am/sir, just the facts"! The media should follow that so they can again become the "News Media" and no longer just the "Opinion Media"! After all, opinions change but factual news doesn't. Given the facts, I think we are sufficiently intelligent to formulate our own opinions.

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Looking Back

With a sleek cheek,
Pressed to hers,
Jeepers! Creepers!
How she purrs.
     Burma Shave