The FDA Law Blog

FEBRUARY 28, 2023

THC acetate esters are different than delta-9-THC, the psychoactive compound found naturally in the cannabis plant. 13, 2023). Dr. Boos explained that delta-9-THCO and delta-8-THCO have similar chemical structures and pharmacological activities as compounds in the cannabis plant so they fall within the definition of THC.

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STAT

OCTOBER 31, 2024

Food and Drug Administration drug shortage list as of Wednesday , raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs, STAT reports. The number of layoffs in the U.S.

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Compounding Pharmacies FDA Compounding Packaging 102

DiversifyRx

JANUARY 31, 2024

Ditch your dependence on PBMs and grow your non-PBM revenue with this review of our top 2023 blogs. Let’s recap the most popular 2023 blog posts that spotlight non-PBM revenue. 5 Proven Strategies for Growing Your Compounding Pharmacy – Top 5 tried-and-true strategies to grow your compounding pharmacy.

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Independent Pharmacies Compounding Pharmacies Compounding 52

Digital Pharmacist

FEBRUARY 8, 2023

Are you already geared up for upcoming conferences or has planning out your show attendances this year fallen by the wayside in the midst of an already-busy 2023? The post 7 Don’t-Miss Conferences for Pharmacists in 2023 appeared first on Digital Pharmacist. We would love to connect in person with you.

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The FDA Law Blog

JANUARY 22, 2024

OCs recent 2023 Annual Report—covering the fiscal year from October ’22 to September ’23—puts some meat on the bones of those issues and describes how OC touches almost every area of enforcement that CDER undertakes. Some takeaways on those efforts that we gleaned from the report: Compounding. Drug Supply Chain.

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Compounding FDA Communication 57

OctariusRx

NOVEMBER 20, 2023

The 2023 version of the OctariusRx USP 800 assessment quiz is about to be released! With the enforcement of USP Chapter 800 beginning on November 1, 2023, facilities will be required to assess staff competency on an annual basis. The post The 2023 USP 800 Assessment Quiz appeared first on OctariusRX. Contact us for assistance.

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OctariusRx

NOVEMBER 7, 2022

The new version of USP Chapter 797 goes into effect November 1, 2023. This is an ideal time to work with someone who has specific expertise on the USP Chapters and knows the required steps for safe handling of compounded and hazardous medications. Additionally, USP Chapter 800 (hazardous drugs) becomes enforceable on the same date.

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pharmaphorum

JANUARY 19, 2023

With a new year comes an opportunity for professionals in the healthcare industry to evaluate goals and initiatives for 2023. In this article, I’ll outline some of the challenges that I anticipate for 2023. The post 2023 predictions and challenges in the healthcare business appeared first on.

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Health and Personal Care Stores Communication HIPAA Patient Care 90

DiversifyRx

JANUARY 4, 2024

Let’s get you caught up with the best independent pharmacy cash-based revenue opportunities in 2023 with our most popular blogs. The year 2023 was another dynamic year for independent pharmacies, filled with challenges and opportunities. Get caught up on the best tactics from 2023. Don’t be a part of the bottom 20%!!

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Independent Pharmacies Compounding Pharmacies Compounding 52

ISPE

NOVEMBER 22, 2022

Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. Trudy Patterson.

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Compounding Packaging Dosage Vaccines 98

European Pharmaceutical Review

OCTOBER 24, 2023

billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 This is projected to grow at the highest compound annual growth rate of 5.27 percent between the forecast period: 2023 and 2028. percent between the forecast period 2023-2028.

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Packaging Compounding Labelling Pharmaceutical Companies 118

pharmaphorum

JANUARY 16, 2023

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. Innovation will power the market.

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pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 96

Pharmaceutical Technology

JUNE 24, 2024

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4%

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Compounding 105

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

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Compounding Dosage Labelling FDA 52

OctariusRx

FEBRUARY 20, 2023

The 2023 controlled substance assessment quiz is about to be released! The post The 2023 Controlled Substance Assessment Quiz appeared first on OctariusRX. This is our first annual competency assessment focused on controlled substances and regulatory compliance. How are you assessing your staff? Contact us for assistance.

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pharmaphorum

MAY 5, 2021

A second is underway in 100 subjects and if positive could result in a green light for the therapy in 2023. The post MDMA on track for 2023 approval as PTSD therapy, says developer appeared first on.

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FDA Compounding 109

Omnicell

JANUARY 10, 2023

Pharmacopeia (USP) published revisions to the general chapters on compounding Nonsterile <795> and Sterile <797> preparations, including robotic technology for the very first time. Sterile compounding is one of the most labor-intensive and risky areas of pharmacy.

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Sterile Compounds Compounding Omnicell Patient Care 98

Pharmaceutical Technology

SEPTEMBER 13, 2023

The company will divest the AVTX-800 rare disease compound series to AUG Therapeutics, with an expected completion in Q4 2023.

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Compounding 59

The People's Pharmacy

MAY 4, 2023

An analysis of more than 100 consumer products reveals that a surprising number contain potentially toxic chemicals called volatile organic compounds ( Environmental Science & Technology , May 2, 2023 ). To identify the compounds, the scientists utilized data from a unique source: the California Air Resources Board.

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Compounding 61

European Pharmaceutical Review

MARCH 11, 2024

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

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Sterile Compounds Compounding Packaging Pharmaceutical Companies 98

European Pharmaceutical Review

MARCH 6, 2024

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds. Internet] European Pharmaceutical Review, Issue 3 2023. 1 References Jaafar-Thiel. cited 2024Mar].

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Method Validation Compounding 105

European Pharmaceutical Review

JANUARY 29, 2024

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. The guideline states that compounds “at or above the AET must be reported for toxicological risk assessment.”

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Compounding FDA 98

European Pharmaceutical Review

APRIL 11, 2023

Therefore, the projected compound annual growth rate (CAGR) is 5.7 million in 2023. The key drivers of this industry include advancements in bioprocessing, development of novel microbial strains for production of high-value compounds and the rising demand for biopharmaceutical products such as antibiotics, vaccines and enzymes.

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Compounding Vaccines 98

European Pharmaceutical Review

OCTOBER 16, 2023

The ADC market is expected to grow at a compound annual growth rate (CAGR) of 20 percent between 2023 and 2028, the contract development and manufacturing organisation (CDMO) highlighted. When the news was announced, Lonza stated the first batches were planned to be fulfilled in April 2023.

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Compounding 105

European Pharmaceutical Review

APRIL 17, 2024

billion in 2023 to $4.3 It is expected hold a compound annual growth rate (CAGR) of 8.20 percent between 2023 and 2032. A report by Market Research Future has predicted that the rapid sterility testing market will increase in value from $2.3 billion by 2032.

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Dosage Compounding 98

European Pharmaceutical Review

NOVEMBER 6, 2023

million in 2023, with a predicted compound annual growth rate (CAGR) of 4.1 Growing application recombinant cell line development in drug toxicity testing is projected to expand the market between 2023 and 2033, the author stated. The global cell line development industry is expected to value $4,674.8

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Compounding Vaccines 105

The Checkup by Singlecare

MARCH 25, 2024

Others have just waited or turned to a compounded version of the drug,” Dr. Jordan says. By May 2023, Ozempic had also landed on the FDA’s Drug Shortages list , complicating the situation for many people with Type 2 diabetes relying on that particular drug. The FDA approved Mounjaro in May 2022 and then Zepbound in November 2023.

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European Pharmaceutical Review

MAY 7, 2024

percent compound annual growth rate (CAGR) between 2024 to 2029. In 2023, North America accounted for the biggest market share due the region’s readiness to invest in innovative solutions such as injectable drug delivery systems. A new report by MarketsandMarkets has predicted that the injectable drug delivery market will reach an 8.6

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Vaccines Compounding Immunization FDA 94

European Pharmaceutical Review

JUNE 28, 2023

million by 2030, growing at a compound annual growth rate (CAGR) of 5.57 percent from 2023 to 2030. percent between 2023 and 2030. percent from 2023 to 2030. According to a report by Verified Market Research, the global high-performance liquid chromatography (HPLC) market is projected to reach a value of $8,084.56

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Compounding 98

STAT

OCTOBER 17, 2024

… Just a handful of networks of doctors, nurse practitioners, and physician assistants are writing prescriptions for dozens of websites offering the GLP-1 weight loss drugs, including the compounded versions that have been the subject of conflict and debate among clinicians and industry members , STAT reports.

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European Pharmaceutical Review

OCTOBER 18, 2023

Europe’s fill and finish services market According to a report published in March 2023 by Roots Analysis, Europe has the largest share of the global aseptic fill finish services market. The research predicted the global aseptic fill finish market will grow at a compound annual growth rate (CAGR) of seven percent between 2023-2035.

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Packaging Compounding 105

The Happy PharmD

OCTOBER 11, 2024

Despite its substantial revenue of $24 billion in 2023, Rite Aid faced a steady decline leading to its eventual bankruptcy filing. Compounding its challenges, Rite Aid became entangled in legal issues, notably linked to the opioid crisis.

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Controlled Substances Compounding 52

The Checkup by Singlecare

DECEMBER 18, 2023

Coffee itself doesn’t contain any cholesterol, but its natural oils contain kahweol and cafestol , two chemical compounds that have the potential to raise cholesterol levels. In other words, yes, the chemical compounds in coffee can raise cholesterol, but the effect coffee has on your cholesterol depends on individual factors.

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Compounding 105

DiversifyRx

APRIL 4, 2024

Help your patients access the hottest weight loss medications with these semaglutide and tirzepatide resources for independent pharmacy owners, whether you compound or not. Is It Legal To Compound Semaglutide and Tirzepatide? Some states might have you check the list every day you compound with either of these APIs (i.e.,

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Independent Pharmacies Compounding Compounding Pharmacies FDA 52

European Pharmaceutical Review

NOVEMBER 28, 2023

Having been valued at $112 billion in 2022, the worldwide cold storage market is projected to witness a 12 percent compound annual growth rate (CAGR) between 2023 and 2032, according to a report by Towards Healthcare. Therefore, by the end of 2032, the market will value an estimated $383.05 billion, the research projected.

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Compounding Vaccines 98

Pharmaceutical Technology

MAY 18, 2023

Gate Neurosciences plans to start a Phase II study of its lead candidate zelquistinel in major depressive disorder (MDD) in Q4 2023, said Rob Houghtaling, Sr. The company finished an initial Phase IIa efficacy study, which showed a rapid antidepressant signal of the compound, says Houghtaling.

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Compounding 52