Highlights From AP Interview With FDA's Hamburg

PRESCRIPTION DRUG ABUSE

Hamburg downplayed suggestions that the agency might remove a heavily criticized painkiller from the market if a harder-to-abuse version becomes available. She said better abuse-deterrent formulas are needed to prevent abusers from chewing, snorting or injecting pain relievers to get high.

"We feel very strongly that the current technologies available are not adequate to truly turn the tide on the epidemic of abuse, and we need continuing advancement in the field of abuse-deterrent technology," Hamburg said.

The FDA has faced months of criticism from elected officials, law enforcement and anti-addiction groups for approving the powerful painkiller Zohydro last October. The long-acting opioid is the first U.S.-approved pure form of hydrocodone, the most abused prescription drug ingredient in the country. Previously it was only available in lower-dose combination pills like Vicodin.

continue to read here

Texas: UTA professor laundered “drug money” police say | Arlington | News from Fo...

UTA professor laundered “drug money” police say | Arlington | News from Fo...

QPharma advises sterile pharmacy compounders to comply with new GMP regulations--"Based on the numerous warning letters that have been issued in recent months, it appears that many compounders are unaware of their regulatory obligations," said Jeff Boatman, QPharma's Senior Subject Matter Expert, Quality Systems and Medical Devices. "Due to the newness of the regulation and the unprecedented degree of validation, it is not surprising that some pharmacies are struggling with compliance."

QPharma, Inc. is advising sterile pharmacy compounders to be aware of their need to comply with new Good Manufacturing Practices (GMP) regulations.
In accordance with federal law, sterile pharmacy compounders that stockpile drug products are now required to register as Outsourcing Facilities — a completely new type of regulated business. Pending written agreements with each state, the U.S. Food and Drug Administration (FDA) is also prohibiting any compounding pharmacy from shipping more than 5 percent of its compounded products across state lines. Under this new classification, any sterile compounder that creates, fills, or packages a drug product without a specific prescription for each package created, or ships any appreciable amount of that product across state lines, is automatically considered an Outsourcing Facility and is subject to federal GMPs.
"Based on the numerous warning letters that have been issued in recent months, it appears that many compounders are unaware of their regulatory obligations," said Jeff Boatman, QPharma's Senior Subject Matter Expert, Quality Systems and Medical Devices. "Due to the newness of the regulation and the unprecedented degree of validation, it is not surprising that some pharmacies are struggling with compliance."
In addition to the GMP implications, individual state Boards of Pharmacy can dictate that sterile pharmacy compounders in their states are subject to process validation, regardless of their activities. For example, QPharma's home state of New Jersey has a pre-existing requirement that sterile compounders perform process validation initially for each drug class, and annually thereafter; while this regulation has been in effect for years, it has taken on new urgency as both federal and state regulatory authorities have begun aggressively inspecting compounders.
In its warning letters, FDA commonly recommends that compounders engage a third-party consulting firm for regulatory support. A leading compliance solutions firm, QPharma is at the ready to help sterile compounding pharmacies close potential compliance gaps and avoid significant penalties.
Source: QPharma 

Interesting Warning Posted Yesterday on Cafepharma from an anonymous source

To all you "sales reps" selling the "transdermal creams, be ready for the harsh reality of a new reimbursement. The insurance companies are well aware of what's happening and are already changing the reimbursement rates. It's over!   quoted from here