Friday, November 29, 2019

16 hours ago - For example, if compounding with bulk substances pursuant to patient-specific prescriptions for nonfood-producing animals, FDA is stating that the drug should be compounded in accordance with applicable United States Pharmacope
4 days ago - (25), "Pharmacy" means any place licensed in accordance with the laws and rules of this state wherein the possessing, displaying, compounding, dispensing, ...

Wednesday, November 27, 2019

7 hours ago - This Viewpoint examines the weak points in adverse event reporting requirements for producers of compounded drugs and offers solutions to improve adver

Federal Prosecutors Launch Criminal Probe of Opioid Makers, Distributors

Federal Prosecutors Launch Criminal Probe of Opioid ... - wsj.com

www.wsj.com/articles/federal-prosecutors-launch...
Federal Prosecutors Launch Criminal Probe of Opioid Makers, Distributors Authorities are using a criminal law more commonly used against drug dealers in pr

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health Clinic had significant donor eligibility violations, including donor screening and testing

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Clinic had significant donor eligibility violations, including donor screening and testing
The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Institute of San Juan, Puerto Rico and its Medical Director and Owner, Dr. Rosa I. Cruz, to immediately cease manufacturing due to significant violations of FDA regulations. An FDA inspection and subsequent record review revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.

“Patients use fertility clinics to help them become parents and they rely on these clinics to follow the appropriate regulatory requirements for screening and testing of donors of reproductive tissue. Patients should not have to worry about being at risk or becoming infected with a ...

States prepare Rx importation plans after Trump assurances

States prepare Rx importation plans after Trump assurances

State officials are moving forward with prescription-drug importation programs on President Donald Trump's repeated assurances that he wants to give states the authority to import drugs from Canada.