Go to http://www.ijpc.com/Webcontent/ for a printable, formatted table.

More information available at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting
Materials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM449535.pdf

Next week: Proposed Evaluation Criteria to be Used by the FDA PCAC for this List

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

Benzocaine Otic Warning
Benzocaine is now the target of an FDA warning which says ear drops, with Benzocaine, can lead to dangerous side effects. One death occurred when a baby was given the drops despite warnings not to use in infants under the age of one. Benzocaine is one of six drugs that have been allowed by the FDA to be on the market but were never evaluated for use in ear drops.
http://www.wsfa.com/story/29718652/fda-issues-warning-about-ear-drops-containing-benzocaine

Tweens and Teens and Over-the-counters
According to national surveys, tweens received a failing grade for knowledge about the proper use of over-the-counter (OTC) medicines; only about half knew such medicines can be dangerous when improperly used or mixed with other drugs. Also, parents said they didn't believe their kids could effectively understand the drug facts on labels. Students entering college have had very little classroom instruction regarding OTC medications; most of what they know about OTC products is what they see advertised in the media and what they learn from other people.
http://www.washingtonpost.com/national/health-science/over-the-counter-drug-literacy-a-must-for-tweens-and-teens/2015/08/04/52cf2506-3ac8-11e5-b759-e3c43f009486_story.html

CVS Strips 31 and Express Scripts Strips 20 More Rx Medications from Insurance Coverage
CVS Health Corp, the nation's second-biggest PBM, said that next year it will exclude an additional 31 prescription medicines from insurance coverage, including widely used treatments for diabetes and multiple sclerosis. When drugs are deleted from coverage, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing. Express Scripts, the nation's biggest PBM, has said it would boot about 20 additional medicines from its formulary in 2016.
http://www.reuters.com/article/2015/08/05/cvs-health-coverage-idUSL1N10G3HE20150805

Three-Dimensional Printing for Medications
Aprecia Pharmaceuticals has received FDA approval for Spritam, the first FDA-approved drug to use three-dimensional printing technology. Spritam is a formulation of levetiracetam that uses the process to prepare rapidly disintegrating tablets. They are building a new facility to make quick-dissolve, easily ingested formulations of highly prescribed high-dose medications. The process "stitches together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that rapidly disintegrates with a sip of liquid." The powder-liquid 3DP technology was developed at the Massachusetts Institute of Technology (MIT) in the late 1980s as a rapid-prototyping technique. Aprecia says its technology allows for delivery of a high drug load, up to 1,000 mg, in a single dose. This opens up endless possibilities for personalized medicine. Projected in the future is where a 3-D printer can follow a recipe given by a pharmaceutical company and produce whatever is needed, on the fly from a set of chemical inks, to produce a medication.

(Editor's Note: Sounds almost like compounding!)

http://www.washingtonpost.com/news/to-your-health/wp/2015/08/04/fdas-approval-of-first-3-d-printed-pill-opens-up-endless-possibilities-for-personalized-medicine/

http://www.fiercepharmamanufacturing.com/story/fda-approves-seizure-drug-made-3-d-technology/2015-08-03

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Did You Know ...

�that when developing a hypothesis or theory when there are insufficient facts, opinions are frequently used? The difficult task is to determine when this occurs.

Tip of the Week

As we see in the theme of the Science Channel, "Question Everything"!

Looking Back

Substitutes!
Smooth guys sell'em,
Easy marks use 'em,
Well-groomed men,
Always refuse 'em!
     Burma Shave