This is the second in the 2-part series looking at the laws and standards related to compounding and the source of ingredients. This week we will look at a comparison of two USP substance monographs; one a USP Dietary Supplement and the other a monograph. Our comparison will include "Glutamine" and "N-Acetylglucosamine."

It is quite apparent from the above that actually the dietary supplement N-Acetylglucosamine has more test requirements than does the glutamine. The USP monographs apparently are NOT held to different standards.

However, what about botanical substances? Do their monographs differ? Let's look and compare Belladonna Extract with Powdered Ginger (dietary supplement).

Presented here are comparisons of two different types of monographs: Single-drug substances and botanicals; it looks like the dietary supplements have just as many, if not more, standards so it is difficult to see why it would be related to the standard requirements.

So, with last week's presentation of the 1) laws, 2) regulations, 3) standards, and 4) the example monograph comparisons presented here showing equivalent or better quality standards for dietary supplements, how can we understand the basis for excluding dietary supplements from the USP official monographs that can be used in compounding?

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

Chinese Pfizer Plant Problems: First India, Now China
A Pfizer Inc. plant in China that was being inspected by FDA regulators in order to ship drugs to the U.S. kept a second set of quality and manufacturing records that didn't match official ones. During an inspection of Pfizer's plant in Dalian, FDA inspectors said in their report that employees hid quality failures, used expired manufacturing materials or ones that hadn't been recently checked, moved around records during the investigation, and retested failing products until they passed. In another plant, the FDA inspectors noticed that one manufacturing unit had only one stand-alone toilet in significant disrepair 50 yards from the aseptic manufacturing unit. Inside the facility inspectors saw no hand-washing station and an open pit that appeared to be used as a urinal.
http://www.bloomberg.com/news/articles/2015-10-30/fda-says-chinese-pfizer-plant-hid-failures-used-old-ingredients

Feds Arrest and Charge Ex-Warner Chilcott Sales Executives
Federal prosecutors announced that they wrapped up a $125 million kickback investigation into Warner Chilcott. They also said Warner's ex-president, W. Carl Reichel, had been arrested on related charges. Reichel's indictment alleges he directed his sales team to treat healthcare providers to free dinners, with no educational agenda, and ask attendees to boost their prescription numbers. Some paid for doctors' family barbecues and holiday parties and if physicians didn't prescribe more Warner Chilcott drugs, sales reps were instructed to stop inviting them to dinners or paying for their parties, the indictment alleges. Heavy prescribers were paid speaking fees of up to $1,200 to attend those dinners, but they weren't there to give speeches.
http://www.fiercepharmamarketing.com/story/feds-arrest-charge-ex-warner-chilcott-sales-execs-kickbacks-case/2015-11-02

Payers Scrutinize Drugmaker-Pharmacy Ties
Express Scripts, the largest U.S. pharmacy benefit manager, is reviewing pharmacy programs run by AbbVie and Teva Pharmaceuticals after finding questionable practices at Valeant Pharmaceuticals partner pharmacy, Philidor Rx Services. Express Scripts and others said they would no longer work with Philidor as concerns mount that Philidor was improperly directing drugs made by Valeant to patients. Some drugmakers operate their own pharmacies and ship drugs directly to patients. Many of the rest employ independent specialty pharmacies that can haggle with insurers and link patients to programs under which drugmakers cover their out-of-pocket costs. These tactics can allow drugmakers to work around reimbursement restrictions from Express Scripts and other insurers, which are directing patients to cheaper generic versions of widely-used medicines to save costs.
http://www.reuters.com/article/2015/10/31/us-valeant-pharmacies-expressscripts-exc-idUSKCN0SO2NE20151031#0mxpxPc7t0c7350z.97

Grandiose Accolades of New Drugs Now Warranted and Can Be a Problem!
"Revolutionary." "Game changer." "Miracle." How much are unproven cancer drugs being hyped? News stories, one after another, are heaping grandiose descriptions on cancer drugs that had not been approved, had shown little ability to extend the lives of patients, or otherwise remained unproven. Researchers searched the Web for coverage of the new drugs in the media and came away concerned that the routine use of superlatives describing the treatments might offer a misleading and overly optimistic view compared to reality. After all, even the best treatments work for only a fraction of patients.
https://www.washingtonpost.com/news/to-your-health/wp/2015/10/29/revolutionary-game-changer-miracle-how-much-are-we-hyping-unproven-cancer-drugs/

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Did You Know ...

�what the results of the October 27-28 FDA PCAC meeting votes on Bulk Substances have suggested? Their recommendation to the FDA was to INCLUDE glutaraldehyde, but to EXCLUDE eight substances: methylsulfonylmethane, curcumin, germanium sesquioxide, rubidium chloride, deoxy-D-glycose, alanyl-L-glutamine, glycyrrhizin, and domperidone.

Tip of the Week

These are only recommendations and are NOT official yet; they must go through the FDA process before coming official.

Looking Back

Baby your skin,
Keep it fitter,
Or "baby" will get,
Another sitter!
     Burma Shave