FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.

Controlled Substances 52

Controlled Substances Documentation Communication 52

FDA Law Blog: Biosimilars

MAY 10, 2023

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. 30,038 (May 10, 2023). By Karla L. 802(54)(G) (which references CMS’s statutory definition of “practice of telemedicine”). . 1307.41and 42 C.F.R.

Controlled Substances 52

Controlled Substances Communication 52

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

National Association of Boards of Pharmacy

JULY 12, 2023

A pharmacy inspector must possess an inquisitive nature and strong communication skills to help them assess each situation appropriately and fairly.   During multiple pharmacy investigations, I discovered that pharmacists were diverting controlled substances for their personal use.

Pharmacy Technician 96

Pharmacy Technician Pharmacy Management Controlled Substances Communication 96

National Association of Boards of Pharmacy

OCTOBER 13, 2022

In the latest round of Drug Enforcement Agency’s (DEA) enforcement action against counterfeit controlled substances (CS), popular apps such as Snapchat, Facebook Messenger, Instagram, and TikTok were involved in one-third of the 390 investigations. These investigations, which took place from May to September, seized a staggering 10.2

Controlled Substances 40

Controlled Substances Communication 40

Quality Matters

MAY 23, 2023

The challenges associated with online pharmacies are not just limited to the distribution of counterfeit medicines – they also include the potential to exacerbate addiction and substance abuse through the availability of controlled substances. kristine.gates… Tue, 05/23/2023 - 10:25 Supply Chain

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This blogger is curious to see what else OPDP has up its sleeve for 2023. But a Warning Letter?

Labelling 52

Labelling Controlled Substances Communication 52