F.D.A. and States Meet About Regulation of Drug Compounders - NYTimes.com:
"Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.
“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”"
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA Designated Representative online training certification - for Drug Wholesalers
FL Designated Representative online exam preparation - for Drug Wholesalers
CA HMDR Exemptee online web-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
Sunday, December 23, 2012
Tuesday, December 18, 2012
CA Board of Pharmacy - Use Of GS1 EPCIS - Pedigree
Follow the link below, to Dirk Rodgers post on the December 4th Board meeting, that touches on some important points surrounding CA pedigree law. . .
California Board of Pharmacy Clarifies Use Of GS1 EPCIS:
". . . transcribed the exchange below as it happened because I think it provides a number of important clarifications about the technologies that can successfully be used to meet the California pedigree law and I think it should be read by everyone who has an interest in that."
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA Designated Representative online training certification - For Drug Wholesalers
FL Designated Representative online internet-based exam preparation by SkillsPlus Intl Inc.
CA HMDR Exemptee online web-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
California Board of Pharmacy Clarifies Use Of GS1 EPCIS:
". . . transcribed the exchange below as it happened because I think it provides a number of important clarifications about the technologies that can successfully be used to meet the California pedigree law and I think it should be read by everyone who has an interest in that."
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA Designated Representative online training certification - For Drug Wholesalers
FL Designated Representative online internet-based exam preparation by SkillsPlus Intl Inc.
CA HMDR Exemptee online web-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
Related articles
- CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)
- What Is A Pharmacy Designated Representative? (skillsplusinfo.blogspot.com)
at
5:00 AM
Labels:
board,
ca,
california,
certification,
designated,
drug,
law,
pedigree,
pharmacy,
representative,
training,
wholesaler
Thursday, December 13, 2012
FDA on Making Medical Devices Safer at Home
Follow the link below for additional free consumer information and resources:
Consumer Updates > Making Medical Devices Safer at Home:
""(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).
However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.
There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected."
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA HMDR Exemptee online training certification - for HME Retailers DME Wholesalers
CA Designated Representative online internet-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online web-based exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
Consumer Updates > Making Medical Devices Safer at Home:
""(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).
However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.
There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected."
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA HMDR Exemptee online training certification - for HME Retailers DME Wholesalers
CA Designated Representative online internet-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online web-based exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
Related articles
at
5:10 AM
Labels:
ca,
california,
certification,
device,
dme,
equipment,
fda,
hmdr,
hme,
home,
medical,
retailer,
training,
wholesaler
Monday, December 10, 2012
How To Get California CDPH HMDR Exemptee Training Certification
You need to take the best and highly recommended California Department of Public Health (Food & Drug Branch) - Exemptee Training Certification course:
The reasons are simple:
Return Home: The Designated Representative and Exemptee Blog
The reasons are simple:
- This training course is incredibly popular
- This is a highly regarded program, taught by a well-respected instructor
- This internet-based online training course can be taken at your leisure 365 x 24 x 7, anytime & anywhere you want, until you fully complete the course
Don't overlook this high quality training offering for home medical device retailers, because it will fit your training certification needs!
-----------------
California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch) |
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):Related articles
- CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)
- Complete Exemptee & Designated Representative Training Before School Ends & Summer Begins (skillsplusinfo.blogspot.com)
- Consider On-Site Training - Popular GMP Classes and QSR Courses (skillsplusinfo.blogspot.com)
Friday, December 7, 2012
Safe Doses Act - Penalties for Pharma Cargo Thefts - Statement by HDMA Pres. John Gray
Follow this link to read John Gray's statement on the passing of the Safe Doses Act . . .
HDMA - Press Releases - 10/09/12:
"President Obama signed into law the Strengthening and Focusing Enforcement to Deter Organization Stealing and Enhance Safety Act of 2011 (SAFE DOSES Act, H.R. 4223/S. 1002). The legislation is sponsored by Congressman Sensenbrenner (R-Wis.) in the House, as well as Senators Schumer (D-N.Y.) and Kyl (R-Ariz.)"
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA Designated Representative online training certification - for drug wholesalers
FL Designated Representative online exam preparation - for drug wholesalers
CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
HDMA - Press Releases - 10/09/12:
"President Obama signed into law the Strengthening and Focusing Enforcement to Deter Organization Stealing and Enhance Safety Act of 2011 (SAFE DOSES Act, H.R. 4223/S. 1002). The legislation is sponsored by Congressman Sensenbrenner (R-Wis.) in the House, as well as Senators Schumer (D-N.Y.) and Kyl (R-Ariz.)"
'via Blog this'
Return Home: The Designated Representative and Exemptee Blog
CA Designated Representative online training certification - for drug wholesalers
FL Designated Representative online exam preparation - for drug wholesalers
CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
Related articles
- CA HMDR Exemptee Training - The Best Course Around (skillsplusinfo.blogspot.com)
at
7:19 AM
Labels:
cargo,
chain,
distribution,
diversion,
drug,
enforcement,
law,
penalty,
pharmaceutical,
SAFE DOSES Act,
supply,
theft,
wholesaler
Monday, December 3, 2012
Public Citizen to FDA - RE: Compounding Pharmacies
Updated June 6, 2024
Links in the original post broke.
You might also be interested in:
--- the original post follows below ---
Public Citizen to FDA: Reinspect Compounding Pharmacies Across the Country | The Legal Examiner Cleveland:
"In an 11-page letter to FDA Commissioner Margaret Hamburg, consumer watchdog group Public Citizen asked the agency to follow up on warning letters it issued to compounding pharmacies committing NECC-like violations.
Since 2003, the FDA has sent at least 18 warning letters to 16 compounding pharmacies, Public Citizen’s letter stated. In light of the 2012 fungal meningitis outbreak, the group would like the FDA to either reinspect those pharmacies or to verify that recent reinspections confirmed that those pharmacies cleaned up their act."
'via Blog this'
You might be interested in:
Public Citizen's Letter to the FDA re: Compounding Pharmacies (PDF)
Return Home: The Designated Representative and Exemptee Blog
For Designated Representative license applicants - Training programs, courses, classes, seminars:
California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:
California (earn a training completion certificate):
at
5:14 AM
Labels:
cgmp,
compounding,
drug,
fda,
gmp,
manufacturing,
pharmacy,
prescription,
Public Citizen
Subscribe to:
Posts (Atom)
Custom Search