This week, we will take an overall look at the U.S. Food and Drug Administration (FDA) Compliance Policy Guidelines (CPGs).

FDA Guidances

Let's look at a breakdown of the FDA Guidances affecting compounding. Some of the Guidances are for 503a pharmacies and some are for 503b outsourcing pharmacies. Some of the Guidances are "final" and some are "draft." The differences are noted as follows:

• This guidance represents the FDA's current thinking on this topic. It does not create any rights for or on any person and is not binding on FDA or the public.

Draft

• This guidance document is being distributed for comment purposes only.
• Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
• This draft guidance, when finalized, will represent the current thinking of the FDA or the Agency on this topic.

Summary Breakdown of Compounding Guidances

In one instance, a "Draft Guidance" is for both 503a and 503b pharmacies.

Next week, we will begin discussing the individual Guidances.

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

News

Nurse Assist Recalls "IV Flush Syringes"
Texas-based Nurse Assist, Inc., has announced a recall of the company's "IV Flush Syringes" because they may be linked to Burkholderia cepacia bloodstream infections. 33 cases of B. cepacia bloodstream infection are linked or associated with the prefilled 0.9-percent sodium chloride injection flush syringes. This product line is about one year old; the FDA cleared the flush syringes in August 2015. The company uses gamma radiation to terminally sterilize the flush syringes. http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=4370

Nicox Cetirizine Plant Troubles Causes FDA Rejection for New Eye Product
French pharma Nicox has been issued a complete response letter from the FDA regarding its cetirizine eye drops after an inspection at a facility that produces the main ingredient. The letter pertains to a GMP inspection at a third-party facility producing the active pharmaceutical ingredient cetirizine, the active ingredient in Johnson & Johnson's Zyrtec. The company is currently working with its suppliers and the FDA to secure a resubmission of the NDA.
http://www.fiercepharma.com/drug-delivery/trouble-at-nicox-cetirizine-facility-prompts-fda-response-letter-and-delay

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Did You Know ...

�that there seems to be a lack of "truth" in politics? Just what is "truth"? Truth is:

• the real facts about something
• the things that are true
• the quality or state of being true
• a statement or idea that is true or accepted as true

Tip of the Week

Since "truth" involves "the things that are true", what does "true" mean? True is:

• being in accordance with the actual state of affairs
• conformable to an essential reality
• fully realized or fulfilled
• being that which is the case rather than what is manifest or assumed
• legitimate, rightful

We try to teach our children and grandchildren to be "truthful"; but our politicians, society, television, etc. are teaching them the opposite! I guess who will win is up to us!

Looking Back

Water heater,
Out of kilter,
Try the brushless,
Whisker wilter!
     Burma Shave