FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

JULY 31, 2023

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).

Controlled Substances 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

Board Vitals - Pharmacist

JANUARY 6, 2023

Upon first renewal, requirements include one hour in HIV/AIDS, professional and medical ethics, Florida laws and rules, and controlled substances, as well as, two hours of domestic violence and medical errors prevention. Licenses must be renewed every two years on October 31st of odd-numbered years such as 2015, 2017 etc.

Controlled Substances 59

Controlled Substances Documentation 59

The Happy PharmD

OCTOBER 11, 2024

However, efforts to merge with Walgreens in 2017 and later with Albertsons in 2018 failed, leaving Rite Aid struggling to redefine its place in a competitive market. Allegations of improper handling of controlled substances and subsequent legal battles resulted in significant penalties and loss of trust from vendors and customers alike.

Controlled Substances 52

Controlled Substances Compounding 52

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured.

Compounding 119

Compounding Drug Development Controlled Substances 119

FDA Law Blog: Biosimilars

APRIL 8, 2024

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. That sterile injectables may be more vulnerable to supply change disruptions is not a novel concept.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59

The Thyroid Pharmacist

NOVEMBER 15, 2024

17] Ozempic is a once-weekly injection that was approved by the FDA in 2017 for use in adults with type 2 diabetes. I also prefer semaglutide drugs over other weight loss drugs out there (for example, phentermine, a controlled substance that can be habit forming, or orlistat, a drug that results in fat malabsorption and “disaster pants”).

Diabetes 75

Diabetes Immunity Immunization Compounding 75