(Learning about USP Chapter <800> in 10 minutes a week.)

4. Responsibilities of Personnel Handling Hazardous Drugs

Editorial Comment: It appears that the necessary training for a DESIGNATED PERSON could be quite extensive and involved, depending upon the type of compounding facility involved. It is important to comply with "what the chapter says" as that is the standard, not what someone "thinks" it says.

NEXT WEEK:
    5. Facilities and Engineering Controls (5.1 and 5.2)

DON'T FORGET TO OBTAIN:

1. NEW!!! [FREE to Subscribers] New SOPs containing each of the 3 NIOSH LISTs as well as a composite LIST in Microsoft Word form are available for downloading. SOPs 14.004, 14.005, 14.006, and 14.008. New SOP 14.007 contains NIOSH LIST Table 5 "Personal Protective Equipment and Engineering Controls for Working With Hazardous Drugs in Healthcare Settings," also in Microsoft Word.

Also, a new 14.003 Hazardous Drugs List is now available.

2. A copy of a USP <800> Gap Analysis [FREE to all] available for downloading.

Both available at: http://www.CompoundingToday.com

4. COMING!!! A LOT more Standard Operating Procedures for USP <800>.

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

Pharmacists Oversupply! What should be done?
The following may be creating more pharmacists than available jobs:
    *increase in pharmacy schools,
    *increase in new graduates, and
    *slow progress towards provider status

The Pharmacy Workforce Center (PWC) released its November 2015 Aggregate Demand Index, and it adds fuel to those arguments revealing that the nationwide supply of pharmacists outnumbers available jobs for the first time in 'recent' history.
http://drugtopics.modernmedicine.com/drug-topics/news/what-should-be-done-about-oversupply-pharmacists

FDA Cites India's Emcure for Fake Data
After the FDA banned most of the sterile products coming out of India's Emcure plant last year, the FDA has now issued a warning letter that says the company routinely used "fraudulent" test data to move drugs through the manufacturing process. Emcure admits "there have been serious gaps in the management, oversight and execution of the environmental monitoring program, especially with respect to the suspected data integrity and falsification of data concerns." One Emcure microbiologist told investigators that because of "work pressure" they often labeled media plates and put them into incubation even though they had never actually been exposed to the environment.
http://www.fiercepharmamanufacturing.com/story/fda-castigates-indias-emcure-routinely-faking-data/2016-03-16

FDA Questions How "Training Products" Entered the U.S. Drug Supply
The FDA has sent letters to two companies selling a medical product intended for training purposes only; the letters were sent more than eight months after recalling the product which was linked to two deaths. The investigation of adverse events was associated with the use of Wallcur's "Practi-0.9% Sodium Chloride" product identified several ways. FDA had sampled 11 of Wallcur's simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples. On it's website, Wallcur says the products are for "training purposes only and are not intended for human or animal use."
http://www.raps.org/Regulatory-Focus/News/2016/03/09/24512/FDA-Questions-How-Company%E2%80%99s-%E2%80%98Training-Products%E2%80%99-Entered-US-Drug-Supply-Chain/

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

Did You Know ...

�that it almost seems like the media is orchestrating the presidential political campaign on both sides?

Tip of the Week

Remember the "X-Files"�"The truth is out there!?" Well, in this presidential campaign, I'm sure the truth is out there somewhere, but I wonder why it is our responsibility to find it instead of the candidate's responsibility to provide it? Maybe we should implement "three strikes (lies) and you're out"!

Life becomes extremely more difficult when you cannot depend upon the truth from people!

Looking Back

Henry the VIII,
Sure had trouble,
Short-term wives,
Long-term stubble!
     Burma Shave