pharmaphorum

DECEMBER 14, 2022

Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy. That’s an objectively long time to have exclusivity of a drug that was first synthesised nearly 100 years ago. Competition starts to heat up. Monopoly money.

Controlled Substances 116

Controlled Substances 116

National Association of Boards of Pharmacy

JANUARY 31, 2024

provided prescribers with the option to use e-prescriptions for controlled substances (CS) based on an interim final rule published in 2010. Medication errors cause avoidable harm in approximately 1 in 30 patients , with 25% of these patients experiencing severe or life-threatening harm.

Prescription Filling 85

Prescription Filling Controlled Substances 85

Pharma in Brief

JANUARY 7, 2024

Biologics, controlled substances, and certain other drugs are not eligible for importation. The export regulations were later incorporated into the Food and Drug Regulations ( FDR ) in 2021. Prescription drugs, biologics, controlled substances, and certain other drugs (FDR section C.01.014.8).

Controlled Substances 52

Controlled Substances Labelling 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.

Labelling 52

Labelling Controlled Substances Communication 52

Pharmaceutical Technology

APRIL 12, 2023

Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production.

Controlled Substances 52

Controlled Substances Dosage Communication Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

These determinations were finalized in 2021. 25, 2021) (“[U]nder the plain statutory language of 35 U.S.C. § 1.750, the PTO takes the position that “Section 156 does not allow for multiple extensions of patents beyond the one patent per one approved product.” See, e.g. , Letter from PTO to FDA CDER, Docket No. FDA-2020-E-1840 (Mar.

Controlled Substances 59

Controlled Substances Hospitals 59

Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i].

Controlled Substances 52

Controlled Substances Communication 52

FDA Law Blog: Biosimilars

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). DEA alleged that UMHS failed to maintain complete and accurate records and failed to timely notify DEA of controlled substance thefts.

Controlled Substances 59

Controlled Substances Hospitals Intravenous Solutions 59

Board Vitals - Pharmacist

JANUARY 9, 2021

As of January 16, 2021) Check with your state’s medical board for the latest updates on pain management and opioid CME requirements. Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Hawaii No opioid CME requirements.

Controlled Substances 52

Controlled Substances 52

National Association of Boards of Pharmacy

OCTOBER 18, 2023

The use of narcotics, other than heroin, increased only slightly from 2021, from 1.0% Although these numbers have declined, sadly, the death toll resulting from adolescents using controlled substances has gone up. of 12th graders reporting use in the last year. of 12th graders reporting the use of narcotics other than heroin.

Controlled Substances 112

Controlled Substances 112

National Association of Boards of Pharmacy

JUNE 6, 2022

Their availability is at least in part due to Drug Enforcement Administration’s (DEA’s) March 2020 decision to loosen remote prescribing restrictions for Schedule III through Schedule V controlled substances (CS) for the duration of the public health emergency.

Online Pharmacies 52

Online Pharmacies Controlled Substances Prescription Filling 52

National Association of Boards of Pharmacy

DECEMBER 6, 2023

Furthermore, xylazine is also associated with physical dependence, withdrawal symptoms, and a general substance use disorder (SUD). While federal law does not classify the drug as a controlled substance (CS), some states have enacted laws or temporary orders to regulate its possession, distribution, and use.

Controlled Substances 73

Controlled Substances Packaging 73

National Association of Boards of Pharmacy

NOVEMBER 22, 2022

In 2021, drug overdose killed 107,622 Americans. To demonstrate the impact of lock-and-suspend, we reviewed estimated website traffic of three domain names that were used to illegally sell prescription drugs, including controlled substances. Authorities tie overdose deaths to illegal online pharmacies. – CDC and DEA.

Online Pharmacies 52

Online Pharmacies Controlled Substances 52

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

National Association of Boards of Pharmacy

SEPTEMBER 18, 2023

The United States is home to one of the most secure drug supply chains in the world, but criminals still find pathways to buy and sell prescription drugs—including controlled substances—often using websites and social media platforms to do so. What are Illegal Online Pharmacies?

Online Pharmacies 85

Online Pharmacies Controlled Substances 85

FDA Law Blog: Biosimilars

APRIL 8, 2024

Specifically, DEA establishes an aggregate production quota (APQ) for each class of controlled substance listed in schedule I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, which limits the amount of each substance that can be manufactured in a given year.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Potency has increased since the last scheduling review, with the average tetrahydrocannabinol (“THC”) potency of marijuana seized by DEA spiking from 3.96% in 1995 to 15.34% in 2021. Letter to Attorney General Merrick Garland and Administrator Anne Milgram, from Elizabeth Warren, et al.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding 59

The Thyroid Pharmacist

NOVEMBER 15, 2024

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”). Published 2021 Apr 1. Published 2021 May 28. Published 2021 May 28. Published 2021 Jul 26.

Diabetes 85

Diabetes Immunity Immunization Compounding 85

FDA Law Blog: Biosimilars

JUNE 23, 2024

Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. 2] Why is this an issue? the “ultimate user”). the “ultimate user”).

Controlled Substances 98

Controlled Substances Compounding 98