FDA Law Blog: Biosimilars

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. 72,694, 72,703 (Dec.

Controlled Substances 52

Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

MAY 31, 2023

However, until today there had been no public information about this decision. On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances.

Controlled Substances 59

Controlled Substances 59

pharmaphorum

SEPTEMBER 5, 2022

Criminals gained access to user login information (credentials) somewhere online. Because many people use the same login information for several websites, the criminals began to test those credentials on other sites and subsequently use them on vulnerable online pharmacies.

Compounding 138

Compounding Online Pharmacies Controlled Substances 138

FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

Controlled Substances 64

Controlled Substances 64

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. §

Controlled Substances 59

Controlled Substances 59

LifeProNow

MARCH 10, 2023

Specific focuses include emerging threats, supporting needs for real-time evaluation, and more continuously accessing, analyzing and aggregating multiple sources of information, such as for recalls, adverse events, outbreaks and pandemics. $16 16 million for regulatory and mission support functions within the Office of the Commissioner.

Labelling 130

Labelling Packaging Controlled Substances 130

pharmacy mentor

JULY 26, 2024

The GPhC often finds that some pharmacies do not adequately verify patient information or validate prescriptions, leading to potential misuse or abuse of medication. Insufficient Safeguards for Controlled Substances Over-Prescribing of High-Risk Medications Controlled substances and high-risk medications require stringent oversight.

Online Pharmacies 52

Online Pharmacies Controlled Substances Adverse Reactions Medication Dispensing 52

pharmacy mentor

JULY 26, 2024

The GPhC often finds that some pharmacies do not adequately verify patient information or validate prescriptions, leading to potential misuse or abuse of medication. Insufficient Safeguards for Controlled Substances Over-Prescribing of High-Risk Medications Controlled substances and high-risk medications require stringent oversight.

Online Pharmacies 52

Online Pharmacies Controlled Substances Adverse Reactions Medication Dispensing 52

Med Ed 101

APRIL 11, 2018

I have a deep appreciation for the safe and appropriate use of medications and tracking and monitoring of controlled substances is an essential component to ensure the safety of our residents In the video below, […]. The post Drug Diversion in Long Term Care – Case Examples appeared first on Med Ed 101.

Controlled Substances 40

Controlled Substances Assisted Living 40

Pharma in Brief

JANUARY 7, 2024

Biologics, controlled substances, and certain other drugs are not eligible for importation. Prescription drugs, biologics, controlled substances, and certain other drugs (FDR section C.01.014.8). 01.014.13).

Controlled Substances 52

Controlled Substances Labelling 52

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. “While our attorneys don’t do this work for the recognition, it is gratifying to see their excellent work recognized.

Controlled Substances 40

Controlled Substances Drug Pricing Drug Development 40

FDA Law Blog: Biosimilars

APRIL 17, 2024

Additional information about DEA’s National Prescription Drug Take Back Day, including local disposal venues, can be found here. Events over the years have led to the removal of more than 17.9 million pounds of unwanted medication across the country. Clear that Cabinet Tour ’24…Don’t you dare miss it!

Controlled Substances 59

Controlled Substances 59

FDA Law Blog: Biosimilars

AUGUST 16, 2023

By Dara Katcher Levy — Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! Let’s go over some background information relating to Breztri and the OPDP Warning Letter. Pretty egregious stuff, right?

Labelling 52

Labelling Controlled Substances Communication 52

FDA Law Blog: Biosimilars

JULY 1, 2024

For each factor, the NPRM noted that for DEA , additional information during the rulemaking w ould inform about the appropriate schedule for marijuana. T he NPRM , however, noted that DEA “has not yet made a determination as to its views of the appropriate schedule for marijuana.” Id.

Dosage 52

Dosage Controlled Substances 52

FDA Law Blog: Biosimilars

MARCH 9, 2023

We prepare a report that we share with our client and make a recommendation to our client about whether to disclose the information to FDA. We might conduct numerous interviews, look at thousands of documents, and travel to whatever locations are necessary. Attorney’s Offices around the country.

Controlled Substances 52

Controlled Substances Documentation 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. For more information download the paper below.

Controlled Substances 52

Controlled Substances Dosage Communication Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

In several letters to applicants, each styled as a REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R. Earlier this month, the PTO issued a REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R. 7,214,695 and 7,214,696 and a PTO request for information as to the first permitted commercial marketing prong of the PTE statute. Patent Nos.

Controlled Substances 59

Controlled Substances Hospitals 59

Pharmaceutical Technology

SEPTEMBER 23, 2022

Since CDMOs have different material handling capabilities, when choosing a partner, it’s important to understand if the drug will involve a controlled substance, hormone, small molecule or biological. This will help determine if there are any special handling requirements. Manufactured in the USA.

Packaging 59

Packaging Controlled Substances Documentation Pharmaceutical Companies 59

Ramblings of a pharmacist

MARCH 28, 2022

They gave all of the right information over the phone to convince customer service that they were in fact our PIC. Pharmacy staff will generally give the information over the phone, thinking little of it. Here’s the story. They placed an order for 67 bottles of Eliquis 60 count and 47 bottles of Xarelto 90 count.

Customer Service 40

Customer Service Controlled Substances 40

FDA Law Blog: Biosimilars

OCTOBER 19, 2023

Additional information about DEA’s National Prescription Drug Take Back Day, including local disposal locations, can be found here. Last April’s Drug Take Back Day alone removed 663,725 pounds (332 tons) of medication at almost 5,000 collection sites hosted by 4,500 law enforcement agencies. So, clear out that stuffed medicine cabinet.

Controlled Substances 40

Controlled Substances 40

National Association of Boards of Pharmacy

JULY 21, 2022

At the end of last year, a bill aimed at stopping illegal online sales of prescription drugs and controlled substances – the?Domain FDA and the Department of Commerce’s National Telecommunications and Information Administration launched a pilot program ?aimed That soon may change.

Online Pharmacies 40

Online Pharmacies Controlled Substances 40

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

The Nontraditional Pharmacist

AUGUST 19, 2019

So currently I work as one of the project managers and QA engineers for Kit Check, where I primarily work on Bluesight for controlled substances and I’ll go definitely go down exactly what that is. Company that focuses on improving pharmacy workflow by providing automated medication management solutions.

Controlled Substances 52

Controlled Substances Hospitals Pharmacy Technician 52

Proxsys Rx

JULY 5, 2023

Our next regulatory challenge was gaining approval from Cardinal CSMP (Controlled Substance Monitoring Program). Regulatory hurdles and delays One of the significant initial delays in meeting all the necessary legal requirements to open was with the Massachusetts pharmacy board — which took four months.

Hospitals 52

Hospitals Inpatient Prescription Filling Controlled Substances 52

Ramblings of a pharmacist

AUGUST 19, 2022

I informed the PBM and heard nothing back. Encryption to validate identity is not a foreign concept to pharmacy transactions – electronically prescribed controlled substances (EPCS) have to have identity validation prior to transmission, usually via some kind of two factor authentication.

Long-Term Care Facilities 40

Long-Term Care Facilities Controlled Substances HIPAA Community Pharmacies 40

epicur

APRIL 24, 2024

Getting the scoop out to people and disseminating the information. For critical medications like controlled substances, it becomes a scramble to find something. A lot of times, I might do a podcast episode and have guests on. I’ll often do webinars, but a lot of times I just post in the community.

Compounding 40

Compounding Controlled Substances Communication Online Pharmacies 40

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. 21 U.S.C. §

Controlled Substances 116

Controlled Substances Documentation 116

FDA Law Blog: Biosimilars

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. 73,044 (Oct. DEA’s notice of updates with the Special Surveillance List is attached here.

Controlled Substances 59

Controlled Substances 59

FDA Law Blog: Biosimilars

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. §

Controlled Substances 53

Controlled Substances 53

Board Vitals - Pharmacist

JANUARY 9, 2021

Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Stay tuned, we’ll update this blog and our Opioid CME offerings as we get more information on new state requirements. Colorado No opioid CME requirements.

Controlled Substances 52

Controlled Substances 52

Quality Matters

MAY 23, 2023

To set the stage, it’s clear that benefits of the Internet’s role can include convenience, rapid access to medical information, privacy, cost efficacy and transparency, at-home access, and the wide range of medicines available. The panel was titled “Securing the Downstream Supply Chain: Internet Pharmacies.” The risks, however, are numerous.

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

National Association of Boards of Pharmacy

JULY 12, 2023

Further, inspections can be hectic, with all the normal activities of pharmacy operations taking place while the pharmacy staff provides regulatory information to the inspector. 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

Pharmaceutical Technology

MAY 9, 2023

“Xylazine started showing up in the dope in Philadelphia around 2010 and recently started to spread across the US, says Jon Zibbell, PhD, a senior public health scientist at RTI International, a non-profit research institute in North Carolina that provides data and analysis to inform public policy.”

Controlled Substances 111

Controlled Substances 111

Pharma in Brief

NOVEMBER 29, 2020

Controlled substances, biologics, and certain injectable drugs are not eligible for importation. They provide the Minister with certain tools to deal with shortages, including the exceptional importation of specific drugs and the ability for the Minister to request specific shortage-related information from anyone who sells drugs.

Controlled Substances 52

Controlled Substances Labelling Communication Vaccines 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

Digital Pharmacist

AUGUST 12, 2022

Using this tool, you can create banners or images with information regarding services you offer. Pharmacies should prepare for higher volumes of controlled substance prescriptions used to treat ADHD like amphetamine salts, dextroamphetamine, lisdexamfetamine, methylphenidate, and dexmethylphenidate.

Controlled Substances 90

Controlled Substances Immunization Immunity Vaccines 90

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. After a buyer has DM’d, the seller frequently directs them to an encrypted messaging app.

Online Pharmacies 85

Online Pharmacies Controlled Substances 85