Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

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FDA Law Blog

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”). Regulated sellers must limit daily sales of SCLPs to 3.6

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Pharmacy Regulation Sales Production 52

STAT News

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

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Pharmacy Licensing Licensing Drugs 70

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2023

Although provisions of the Pharmacy Practice Regulations (PPR) 2015 are not there in the Drugs and Cosmetics (D&C) Act 1940 but are framed under the Pharmacy Act 1948, the steps now being taken by the drugs control administration (DCA) in Tamil Nadu in a motive to strengthen the dispensing activities in pharmacies are completely agreeing […] (..)

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Cosmetics Pharmacy Regulation Drugs 156

Medical Xpress

DECEMBER 13, 2022

Researchers from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences recently published in Molecular & Cellular Proteomics, describing their work in identifying key metabolic regulators involved in cancer cell resistance to gemcitabine (Gem), a standard-of-care chemotherapy for pancreatic dual adenocarcinoma (PDAC), the most lethal (..)

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Regulation Research Pharmacy Drugs 75

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

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Pharmacy Trials Clinical Trials Clinical Trials 52

Pharmacy Checkers

FEBRUARY 7, 2020

When you go to your local CVS and Walgreens – and other big pharmacy chains – are you getting the highest standard of care? Have these pharmacies gone rogue? Yet the National Association of Boards of Pharmacy (NABP) doesn’t seem to be paying much attention to medication errors at U.S. pharmacies. pharmacy industry.

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Pharmacy Regulation Drugs Medicine 74

FDA Law Blog

NOVEMBER 10, 2022

Company Pays $158,760 to Resolve Claims Related to Controlled Substance Thefts From Pharmacies During Inventory, U.S. Affiliated companies RGIS LLC (“RGIS”) and Retail Services WIS Corporation (“WIS”) provide inventory services to retail stores, including pharmacies, throughout the U.S. 29, 2022), at [link]. While neither the U.S.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

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Drug Channels

AUGUST 18, 2020

Hospitals and health systems are building a major presence in the specialty pharmacy industry. As we demonstrate below, nine out of ten large hospitals now operate a specialty pharmacy. accredited specialty pharmacies. Clinical and general financial motivations are driving hospitals’ DIY specialty pharmacy growth.

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Pharmacy Regulation Drugs Manufacturing 52

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 12, 2023

The Central government has notified the administrative Rules for the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory Committee to regulate and monitor experiments on animals to prevent cruelty to animals, with provisions for deemed approval and grading of animal house facilities in medical colleges, pharmacy colleges, (..)

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Pharmacy Checkers

FEBRUARY 28, 2020

The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). On the subjects of drug importation, online pharmacy verification, drug safety and affordability, the word “legitimate” is thrown around a lot. wholesale pharmacy $80,000.

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Pharmacy Drugs Sales Compliance 55

Outsourcing Pharma

JANUARY 13, 2021

The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.

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Pharmacy Drugs Regulation Marketing 83

XTalks

MARCH 15, 2024

In an era where telemedicine is rapidly transforming the landscape of healthcare, Precision Compounding Pharmacy stands out as a beacon of innovation and excellence. Under the leadership of CEO Christian Stella , PharmD, Precision has carved a niche for itself, not just as a pharmacy but as a vital player in the telemedicine ecosystem.

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Pharmacy Compliance Regulation Medicine 59

STAT News

JANUARY 19, 2023

WASHINGTON — Federal regulators’ green light for pharmacists to dispense abortion pills is crashing into legal questions and simmering court battles. The Food and Drug Administration earlier this month removed a longtime restriction that only doctors could dispense mifepristone, which is approved for abortions up to 10 weeks.

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STAT News

DECEMBER 23, 2022

These highly regulated facilities are made up of multidisciplinary teams of physicians, nurses, counselors, and social workers who provide comprehensive medication-assisted treatment. Many Americans with opioid use disorder go to one of the nearly 2,000 opioid treatment programs (OTPs) in the U.S. to receive high-quality, evidence-based care.

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The Pharma Data

DECEMBER 10, 2020

Pharmaceutical Care Management Association , the Court recognized that state legislatures have important powers to regulate abuses of corporate healthcare middlemen, called Pharmacy Benefit Managers (PBMs). PBMs can exercise enormous economic leverage over pharmacies.

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Regulation Pharmacy Drugs 52

Pharmaceutical Technology

MARCH 10, 2023

The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials. The company expects to launch Zavzpret in pharmacies in July. “Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.

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FDA Approval Pharmacy Trials Clinical Development 246

STAT News

DECEMBER 17, 2022

Due to increased demand for the medication, pharmacies may experience delays in receiving full shipments of the 5-milligram dose through January, according to a posting this week on the regulator’s website. Continue to STAT+ to read the full story…

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Drugs Pharmacy Regulation 98

FDA Law Blog

NOVEMBER 7, 2021

Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). A key issue before the court was whether, despite the relevant statute’s silence on the issue, Congress intended to allow the use of contract pharmacies.

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Pharmaceutical Technology

JUNE 5, 2023

Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia. Pharmacies have also received EU General Data Protection Regulation (GDPR) fines for not being in compliance,” he adds.

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STAT News

AUGUST 16, 2022

The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. The devices will be sold online or over-the-counter at pharmacies and other retail stores. Read the rest…

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Pharmacy Regulation Drugs 98

STAT News

MARCH 29, 2023

British Columbia plans to limit sales of the popular diabetes drug Ozempic to Canadian residents in response to a wave of Americans flocking to local pharmacies in search of the drug, potentially straining supplies in the province. residents, according to a Tuesday release from the province.

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Pharmacy Sales Regulation Drugs 116

FDA Law Blog

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. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. 48365, 48369 (July 27, 2023).

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Pharmacy Regulation Licensing Licensing 52

FDA Law Blog

NOVEMBER 29, 2021

Palmer — DEA is proposing to amend its regulations to expressly permit the transfer between pharmacies of an initial controlled substance prescription. Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the prescription.

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FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Palmer , Larry K. Houck , and Kalie E.

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World of DTC Marketing

JUNE 22, 2022

The company has hired former senior health regulators to help it navigate America’s healthcare bureaucracy. . But Express Scripts, which manages pharmacy benefits for 100 million people, is telling pharmacies to dispense the more expensive Advair brand because it won’t cover Mylan’s generic.

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FDA Law Blog

SEPTEMBER 30, 2021

This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. Section 503A’s language requires FDA to promulgate a MOU to “address” the “distribution” of “inordinate amounts” of compounded drugs interstate and that it “shall issue regulations” to do so. By Karla L.

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Pharmacy Production Drugs Regulation 98

Outsourcing Pharma

OCTOBER 19, 2023

A collaboration has been formed between the US pharmacy chain Walgreens and the Cardiovascular Research Foundation (CRF) to measure how prevalent valvular heart disease (VHD) is among older Americans.

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Research Pharmacy Regulation Marketing 97

STAT News

OCTOBER 25, 2022

Food and Drug Administration regulate drugs, including approved uses and claims made by ads and product labels. Meanwhile, states regulate the actual prescribing events — providers, pharmacies, and medical practice standards. Federal agencies like the U.S. Continue to STAT+ to read the full story…

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Regulation Pharmacy Production Drugs 98

Pharma in Brief

OCTOBER 29, 2020

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

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Pharmaceutical Technology

OCTOBER 31, 2022

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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FDA Approval Pharmacy Licensing Licensing 147

Pharmacy Checkers

JUNE 4, 2020

Using very similar talking points to Big Pharma-funded experts , in its quest to “educate” the public about the dangers of internet pharmacies and personal medicine imports, the National Association of Boards of Pharmacy (NABP) appears to have ignored the greatest pharmacy-related public health travesty happening right under its nose.

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pharmaphorum

NOVEMBER 16, 2022

Walmart has become the latest big pharmacy chain in the US to put forward a settlement to resolve claims it contributed to the national opioid crisis by failing to regulate prescriptions at its outlets. The retail giant has confirmed it has offered $3.1 The retail giant has confirmed it has offered $3.1

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World of DTC Marketing

OCTOBER 4, 2021

From my estimates, most of it failed because pharma companies are afraid of misinformation concerning regulations around DTC marketing. Spots for Amazon Pharmacy were found on over 30 health misinformation sites. A year ago, Facebook was making a hard charge to get the pharma business. Bob Hoffman.

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