STAT

MARCH 26, 2024

German health agency G-BA issued guidance last week saying regulation banning Germany’s health system from paying for weight-loss drugs would not apply in the case of other approved uses, a boost for Novo Nordisk’s efforts to convince governments of its wider medical benefits. Our choice today is blueberry muffin.

Drug Pricing 249

Drug Pricing Insurance Coverage and Processing Diabetes Pharmaceutical Companies 249

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

NABP is proud to offer accreditation and inspection programs for pharmacies, drug distributors, and medical device distributors. Before coming to NABP, I worked in various hospital pharmacy settings and served on the State of Ohio Board of Pharmacy as a Compliance Specialist.

Sterile Compounds 59

Sterile Compounds Controlled Substances Compounding Hospitals 59

National Association of Boards of Pharmacy

JULY 12, 2023

Careers in pharmacy involve lifelong learning and adaptation to new situations. In this feature, a Virginia pharmacy inspector discusses her ever-changing role in the field. Amy Branson, PharmD, RPh  Pharmacy Inspector, Virginia Department of Health Professions  How long have you been serving as a pharmacy inspector for the Board?

Pharmacy Technician 96

Pharmacy Technician Pharmacy Management Controlled Substances Communication 96

FDA Law Blog: Biosimilars

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. Keup has joined the firm to assist attorneys Karla L. Palmer , Larry K.

Controlled Substances 45

Controlled Substances Documentation Pharmaceutical Manufacturing Communication 45

National Association of Boards of Pharmacy

MAY 20, 2022

We’ve been working with the boards of pharmacy, other regulators, and trading partners to prepare for the requirements included in Title II of the Act, which calls for product tracing at the package level. We are continuing to collaborate with stakeholders across the pharmacy industry to develop this interoperable DSCSA network.

Communication 52

Communication Packaging 52

FDA Law Blog: Biosimilars

JULY 31, 2023

With the amendment by CARA, the CSA allows for partial dispensing of schedule II prescriptions if not prohibited by state law, is requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 78,282 (Dec.

Controlled Substances 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

RX Note

MARCH 28, 2024

Introduction Apart from Poisons Act 1952 and Regulations , we should also have a fair understanding on Dangerous Drugs Act 1952 and Regulations to be well prepared for Qualifying Examination to Practice Pharmacy. 1 of the Third Schedule will be regulated as dispensed medicines under Poisons Act 1952 and Regulations.

Documentation 52

Documentation Drug Storage Compounding 52

Quality Matters

MAY 23, 2023

Internet Pharmacies are an Often-Overlooked Part of the Medicines Supply Chain Many patients and consumers have a mental picture of the last leg of the pharmaceutical supply chain as a neighborhood drug store where they pick up their prescriptions. The panel was titled “Securing the Downstream Supply Chain: Internet Pharmacies.”

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

RX Note

MARCH 28, 2024

Introduction Today, we are going to have a small discussion on application of Poisons (Psychotropic Substances) Regulations 1989 under Poisons Act 1952 in community or hospital pharmacy setting.

Dosage 40

Dosage Hospitals Packaging Documentation 40

Pharmaceutical Technology

JUNE 5, 2023

HIPAA laws are a series of federal regulatory standards relating to the Health Insurance Portability and Accountability Act of 1996, outlining the lawful use and disclosure of protected health information in the US. They tried to make money with ransomware, data theft, or other attacks.”

HIPAA 110

HIPAA Pharmaceutical Companies Pharmaceutical Companies 110

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.

Specialty Pharmacies 76

Specialty Pharmacies Drug Pricing Biosimilars 76

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

Controlled Substances 52

Controlled Substances Documentation Communication 52

RX Note

FEBRUARY 4, 2024

Most community pharmacies routinely provide preventive services like blood pressure, glucose and lipid screenings. Minor Illness Minor ailments schemes in the United Kingdom allows patients eligible for free National Health Service (NHS) prescriptions to go directly to pharmacies and request medicines. Watson et al. Watson et al.

Community Pharmacies 52

Community Pharmacies Medical Records Compounding Diabetes 52

National Association of Boards of Pharmacy

AUGUST 5, 2022

Boards of pharmacy can face unexpected challenges while working to protect the public health. Executive Director, North Carolina Board of Pharmacy. How long have you served as executive director of the North Carolina Board of Pharmacy? Here, board executive directors talk about how they worked around these obstacles.

Community Pharmacies 40

Community Pharmacies 40

Express Pharma

AUGUST 1, 2023

The loss of exclusivity of AbbVie’s Humira (adalimumab) has become a perfect scenario to test if the Biologics Price Competition and Innovation (BPCI) act in the US can achieve the intention of the law. Humira has long been a very profitable asset for AbbVie, with steadily rising annual US sales since its launch in 2002; peaking at $18.6

Biosimilars 98

Biosimilars 98

National Association of Boards of Pharmacy

DECEMBER 6, 2023

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. The emergence of illicit falsified prescriptions containing synthetic opioids, notably fentanyl, has contributed to this crisis.

Controlled Substances 72

Controlled Substances Packaging 72

Digital Pharmacist

OCTOBER 12, 2022

Below we’ll discuss types of testing and benefits to pharmacies for offering this service. It has been estimated that more than 78 million visits to the physician office over a 10 year period are for acute pharyngitis, and among those 15% to 30% of cases originated from Group A Streptococcus (GAS) and 2% from Influenza. Types of Testing.

Physician Offices 98

Physician Offices Hospitals Pharmacy Management Vaccines 98

pharmaphorum

JANUARY 12, 2023

The Attorney General of Alabama has threatened to use an obscure law passed in 2006 to prosecute women who terminate a pregnancy using pharmacological means, shortly after the FDA made access to the drugs easier. AG Steve Marshall. ” The post Women in Alabama could face prosecution over use of abortion pills appeared first on.

Controlled Substances 52

Controlled Substances 52

National Association of Boards of Pharmacy

JANUARY 13, 2023

Inspectors and investigators are the eyes and ears for boards of pharmacy, ensuring compliance with pharmacy law and practice standards. Kinderknecht, RPh Pharmacy Inspector, Kansas State Board of Pharmacy How long have you been serving as an inspector for the Board? I owned a retail pharmacy for 21 years.

Pharmacy Technician 52

Pharmacy Technician Independent Pharmacies Nursing Homes Patient Counseling 52

pharmaphorum

JULY 22, 2022

The pair have been found to have exploited a loophole by de-branding phenytoin sodium capsules – formerly known as Epanutin – so they were no longer subject to price regulations. It referred this matter back to the CMA for further consideration – known as a remittal.

Drug Pricing 111

Drug Pricing 111

European Pharmaceutical Review

JUNE 24, 2022

2022 is probably the biggest year in EU pharmaceutical law that I have seen in 30 years. This means numerous key aspects of how pharmaceuticals are regulated in the EU could be affected, from costing and reimbursement to intellectual property rights, incentives and more. proof and crisis-resistant.

Compounding 96

Compounding Drug Development Drug Pricing Dosage 96

RX Note

NOVEMBER 13, 2023

Introduction Over the past few years, there is a growth in retail pharmacies in Malaysia. The overall number of pharmacies in Malaysia increased from 2889 in December 2018 to 3835 in June 2022. location and number of competitors) A new pharmacy should be located at least 300 meters radius from an existing pharmacy outlet.

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Documentation Independent Pharmacies 52

epicur

DECEMBER 19, 2022

The two areas addressed by GFI 256 include: Office stock (aka “office use”): To obtain a drug for office stock from a 503A compounding pharmacy, the active ingredient, strength, dosage form, and species it is to be used in MUST be on the list provided by the FDA on their website found ( here ). Let’s start with the basics.

Compounding 52

Compounding Compounding Pharmacies Documentation Dosage 52

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

National Association of Boards of Pharmacy

APRIL 19, 2023

Industry Readiness While some manufacturers have started making transaction records available to direct customers (such as distributors or pharmacies), many have not. NABP has ramped up efforts in this area to help states work together to understand, develop plans, and guide the pharmacies they regulate into compliance.

52

52

epicur

DECEMBER 5, 2022

However, retail stores and online pharmacies have stolen a lot of market share, especially during the pandemic. These online retailers not only pose a threat to veterinary practices’ revenue, but they also create challenges in regulating quality animal healthcare standards. Bn in 2020 to over US$ 2.7 Bn in 2020 to over US$ 2.7

Compounding 52

Compounding Compounding Pharmacies Packaging Hospitals 52

Birth Control Pharmacist

JANUARY 24, 2022

In the coming months, mifepristone (Mifeprex) is anticipated to have an updated Risk Evaluation and Mitigation Strategy (REMS) Program that allows dispensing through local brick-and-mortar and mail-order pharmacies. Background. Patients first take mifepristone, followed by misoprostol in 24 to 48 hours.

Mail-Order Pharmacies 52

Mail-Order Pharmacies 52

Ramblings of a pharmacist

MAY 3, 2022

Most of a pharmacy’s revenue is determined according to a formula called “lesser of logic” (which I’ve previously argued should be illegal, at least in part, due to its upward pressure on pricing generally). A common refrain from independent pharmacists is that they don’t have control of their pricing.

Packaging 40

Packaging 40

National Association of Boards of Pharmacy

APRIL 3, 2024

Review P&Ps P&Ps must be consistent with laws and regulations, as well as accreditation standards, if applicable. Steps your business can take to prepare for an on-site inspection, accreditation, or review can include: Review Policies and Procedures (P&Ps) to ensure they are consistent with business operations.

Documentation 45

Documentation 45

Quality Matters

OCTOBER 10, 2023

Standards on the Frontlines: Responding to public health crises and strengthening supply chains Vulnerabilities or disruptions to the global medicine supply chain (including drug shortages) continue to make headlines. The culprit—over-sulfated chondroitin sulfate (OSCS)—was discovered to have been substituted for some actual heparin.

Adverse Reactions 52

Adverse Reactions Compounding 52

Birth Control Pharmacist

JUNE 24, 2021

How does it apply to pharmacy practice? Reproductive justice is “the human right to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities” as defined by SisterSong Women of Color Reproductive Justice Collective [1].

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state. Best price?

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

European Pharmaceutical Review

DECEMBER 19, 2022

The question of whether biosimilars are interchangeable – and possibly even automatically substitutable at pharmacy level – remains a national prerogative, rather than one that can be mandated at an EU-level, as noted in the EMA’s guideline: 4. Biosimilars therefore do not qualify as copies (or ‘generic’ versions) of the reference product.

Biosimilars 52

Biosimilars 52

Proxsys Rx

AUGUST 26, 2022

Trusting 340B ESP to Restore Prices On Its Promised Scheduling Don’t ever assume that 340B prices are restored in your contract pharmacies’ 340B wholesaler accounts by the 10-day post-submission mark (the time frame 340B ESP says to allow).

Packaging 52

Packaging Hospitals 52

Quality Matters

OCTOBER 13, 2021

can get a prescription filled at our neighborhood pharmacy and trust that the medicine we receive will be safe and work as it should. can get a prescription filled at our neighborhood pharmacy and trust that the medicine we receive will be safe and work as it should. In fact, quality standards are a big reason why we in the U.S.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Adverse Reactions Prescription Filling Compounding 52

National Association of Boards of Pharmacy

AUGUST 29, 2022

At the end of July, INTERPOL announced the execution of Operation Pangea XV , an annual week of coordinated law enforcement action to combat the illegal sale of medicines and medical products online. Certain products are more popular online, but every year the offerings of illegal online pharmacies become more diverse.

Online Pharmacies 40

Online Pharmacies Labelling 40

pharmaphorum

AUGUST 5, 2021

The authority says the two companies were the two dominant suppliers of the drug at the time, and “exploited a loophole” by de-branding the drug so it was no longer subject to price regulation. Fast forward to today, and the CMA has published a Statement of Objections accusing the two companies of breaking competition law.

Drug Pricing 52

Drug Pricing 52