Tuesday, May 28, 2013

Dirk Rodgers on Pedigree Law (Federal & CA) & Funding

The California Pedigree Law implementation date is fast approaching . . .

Would A U.S. Federal Pedigree Law Require A New UFA?:

"NOTE: We are just about 1-1/2 years away from January 1, 2015, the first date that manufacturers must serialize some of their drugs and start drug pedigrees. From this point on, time is going to go by pretty fast for companies who are not yet ready."

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Saturday, May 25, 2013

Compounding A Crisis At FDA - Forbes Article

Updated June 10, 2022

You might also be interested in:

---  the original post follows below  ---

This is about legislative proceedings happening right now in Washington. Follow the link below to a short commentary.

Compounding A Crisis At FDA - Forbes:

"But all of this doesn’t change the fact that some “compounding” pharmacies are operating as drug makers under the guise of a pharmacy license, breaking existing law, and creating public risks. They are manufacturing drugs with none of the oversight that ensures that their processes are sterile and safe. FDA’s recent inspections of some of these facilities have surfaced widespread, and potentially dangerous biological contaminations of these products. Another tragedy is just a matter of time."

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Thursday, May 16, 2013

FDA Concerned About Damaged-Soiled Medical Bed Mattresses

Updated October 22, 2021

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Safety Alerts for Human Medical Products > Medical Bed Mattresses: FDA Safety Communication - Damaged or Worn Covers Pose Risk of Contamination and Infection:

"Medical literature shows that damaged and wet (soiled) mattresses can be a source of contamination during infection outbreaks. The FDA is concerned that fluid ingress from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by health care providers, health care facility staff, and caregivers. The FDA will continue to monitor this issue and keep the public informed if new information becomes available."

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Tuesday, May 14, 2013

Summer's Here! Complete Training Certification Before Vacation

It's Summer-time!

Don't let your Exemptee training or Designated Representative training hang over your head going into Summer.

Just get it done now, before:
  • the kids get out of school
  • you find yourself on vacation
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Visit www.DREprof.com to learn more and buy California Exemptee Training, and California Designated Representative Training
Visit www.DREprof.com to learn more and buy California Exemptee Training, and California Designated Representative Training

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Thursday, May 2, 2013

Cargo Thefts Target Pharmacy Deliveries

Cargo thefts spike as robbers target pharmacy deliveries - FiercePharma Manufacturing:

" . . . a surge of attacks on the smaller courier-service vans that make deliveries from distribution warehouses to local pharmacies. "The increase is such that we now differentiate between FTL (full truckload) thefts between a manufacturer and a wholesale center and those between wholesaler and retailer," he said in a telephone interview."

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For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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