pharmaphorum
SEPTEMBER 5, 2022
One, someone who should not be able to get their hands on these controlled substances can. Criminals gaining access to controlled substances by simply picking them up at pharmacies is incredibly problematic, especially considering the massive and ongoing opioid crisis.
epicur
NOVEMBER 10, 2022
Have you ever broken or spilled a bottle of a controlled substance? 5 Reminders for Properly Documenting a Spilled or Broken Bottle of a Controlled Substance A spill or breakage does not constitute a loss because the registrant can account for the controlled substance. If so, did you document it?
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FDA Law Blog: Biosimilars
JANUARY 18, 2024
Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. 21 U.S.C. §
FDA Law Blog: Biosimilars
AUGUST 21, 2023
Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ).
Pharmaceutical Technology
DECEMBER 5, 2022
Cannabinoid-based drugs are derived from compounds found in the cannabis plant. However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. Despite this, the medical use of cannabinoid drugs is heavily restricted, including being banned in 137 countries, according to the United Nations.
The Happy PharmD
OCTOBER 11, 2024
Compounding its challenges, Rite Aid became entangled in legal issues, notably linked to the opioid crisis. Allegations of improper handling of controlled substances and subsequent legal battles resulted in significant penalties and loss of trust from vendors and customers alike.
Pharmaceutical Technology
NOVEMBER 17, 2022
According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. However, site selection and facility acquisition can be a challenge, as well as being a major capital expenditure (CAPEX).
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