European Pharmaceutical Review

NOVEMBER 21, 2024

What psychedelic compounds have shown the most promise or are better suited for certain conditions? Each of the compounds has unique properties and may be better suited for certain conditions. References FDA Briefing Document. For example, MDMA has shown promising results in the treatment of PTSD, as seen in recent trials.

Compounding

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process.

Packaging

Pharmacy Times

AUGUST 11, 2025

Because documentation of medication lists is a key component of MTM, pharmacists are well positioned to incorporate this into transitions of care.” Community pharmacists significantly impact these transitions through medication reviews at the point of dispensing and during medication therapy management (MTM) encounters.

Medication Therapy Management (MTM)

Pharmacy Times

JUNE 9, 2025

Pulmonary function tests and provider documentation were manually reviewed to confirm asthma diagnoses, while individuals with other pulmonary diseases were excluded. 1 The study also observed that 65% of patients had a documented visit with an asthma specialist during the follow-up period.

Pharmacy Technician

Putting Patients First Blog

JUNE 26, 2025

At the same time, the NHC recommends that CMS avoid incorporating the MFP into ASP calculations, as doing so could depress reimbursement rates across both Medicare and commercial markets, compounding access risks and straining provider viability. A first priority is clarifying how providers should submit claims for drugs subject to the MFP.

Drug Pricing

GMPSOP

JUNE 15, 2025

Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. 250 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Pharmaceutical Manufacturing

Express Pharma

JUNE 20, 2025

Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.

Documentation

Pharmacy Times

JUNE 17, 2025

During this time frame, the pharmacy documented 152 interventions. If a discrepancy is found, the pharmacy nurses will hold the shipment, and a clinical intervention will be communicated to the provider. Results American Oncology Network (AON) Pharmacy collected data on waste and cost avoidance from February 2023 to September 2023.

Mail-Order Pharmacies

Pharmacy Times

JUNE 20, 2025

It’s also helpful to hear from managed care experts—understanding their concerns and what documentation is needed to ensure patients can get coverage for the latest treatments. I love that OPC is positioned so close to ASCO because pharmacists often can’t attend large meetings due to travel restrictions and limited funding.

Pharmacy Technician

Pharmacy Times

AUGUST 12, 2025

7015 FDA Advisory Committee Briefing Document: Columvi (glofitamab-gxbm) plus GemOx. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. J Clin Oncol. 2025;43(suppl 16). doi:10.1200/JCO.2025.43.16_suppl.7015

Pharmacy Technician

Pharmacy Times

JULY 22, 2025

Artificial intelligence (AI) platforms such as PGxAI are now automating literature review, guideline development, and reimbursement documentation, enabling pharmacogenetic innovation to move from discovery to clinical application in months rather than decades.

Pharmacy Technician

Pharmacy Times

JULY 2, 2025

They can collect documentation on prior preventive therapies, baseline MMDs, and follow-up outcomes to support prior authorization, including site-of-care arrangements. of participants discontinued due to adverse effects.

Pharmacy Technician

Pharmacy Times

JULY 2, 2025

The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC. The CRL was received after OLC’s initial Prescription Drug User Fee Act date of June 28, 2025, and cited for deficiencies that are unrelated to OLC itself.

Pharmacy Technician

Pharmacy Times

JUNE 20, 2025

Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C. Dysmenorrhea, also known as painful menstruation, is the most commonly reported menstrual symptom among females during the reproductive years.

Pharmacy Technician

Pharmacy Times

JULY 1, 2025

We all share the same electronic health record and document every patient interaction in the health record, and we have very easy access to reach out to the patient's provider to let them know of any questions or concerns that the patient has regarding their medication.

Insurance Coverage and Processing

Pharmacy Times

JUNE 22, 2025

Sayer: The most documented, most significant benefits If you take a look at the trials we've run, first of all, you always see an A1c reduction, because average glucose values go down and A1c follows. Even just glucose numbers, that's way more than they've had before.

Diabetes

Pharmacy Times

JULY 17, 2025

Patients were excluded if they had a primary mental health diagnosis of a substance use disorder or no documented Behavioral Health Initial Assessment Form in the electronic medical record. Due to incomplete documentation, the MARS score could not be calculated for all the patients.

HIV Treatment and Prevention Agents

Pharmacy Times

JULY 18, 2025

Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations.

Compounding

Pharmacy Times

AUGUST 7, 2025

Document stamped with "FDA Approved" next to magnifying glass | Image Credit: © aznan - stock.adobe.com CLL/SLL prognoses have greatly improved over the past few decades with the emergence of novel targeted therapies and immunotherapies.

HIV Treatment and Prevention Agents

Pharmaceutical Commerce

JULY 16, 2025

1 In response to this immense demand, coupled with high costs and accessibility issues, compounded alternatives have emerged as a seemingly pragmatic solution. However, these compounded GLP-1s are creating a significant, often underestimated, legal, reputational, and financial minefield for startups and the broader life sciences industry.

Compounding

Putting Patients First Blog

JUNE 16, 2025

Developers should be required to: Conduct inclusive usability testing with older adults, people with disabilities, caregivers, and individuals with limited English proficiency; Share documentation of feedback collection and integration; and Comply with Section 508 and WCAG 2.1 Incentivizing the use of HL7 FHIR, OAuth 2.0,

Documentation

Pharmacy Times

JULY 9, 2025

2 Evidence Supporting Supplementation A randomized controlled trial involving high-dose vitamin D (300 IU/kg/day, up to 5000 IU/day) in children with ASD documented meaningful improvements in Childhood Autism Rating Scale (CARS) scores, repetitive behaviors, eye contact, and attention after 4 months, without toxicity.

Pharmacy Technician

Pharmacy Times

JUNE 23, 2025

We just must do a good job of documenting them and develop that clinical evidence base that supports it. It's time for another compound. In our state of type 2 paper that we published in conjunction with this meeting, one of the things that was very interesting to me was that there were like 111 health care professional surveys.

Diabetes

PharmaTech

JULY 17, 2025

3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. antineoplastics, allergens). antineoplastics, allergens).

Compounding

Pharmaceutical Technology

JULY 2, 2025

The projected growth of the cell and gene therapy market GlobalData estimates that the cell and gene therapy market will achieve global sales of $76.03bn by 2030, up from $5.88bn in 2023, with a compound annual growth rate (CAGR) of 44% over the seven years analysed. of the global market, valued at $39.3bn.

Packaging

Pharmacy Times

AUGUST 7, 2025

The CDC updated its guidance for international travelers in May 2025 with stronger language, urging that all adult international travelers receive 2 doses of the MMR vaccine separated by at least 28 days unless they have written documentation of measles immunity.

Immunity

Pharmacy Times

JULY 29, 2025

Geison’s findings, which draw on Pasteur’s previously inaccessible laboratory notebooks, offer detailed documentation of how public scientific claims may be shaped by selective presentation of data. 2018;153(7):663-670. doi:10.1001/jamasurg.2018.0040

Pharmacy Technician

The Thyroid Pharmacist

AUGUST 1, 2025

You can also try using oxytocin nasal spray that you can get prescribed and compounded by your compounding pharmacist, taking Epsom salt baths, or using essential oils like lavender and clary sage. [60] Variations in the rancid-flavor compounds of human breastmilk under general frozen-storage conditions. 2006 Apr;4(4):455-9.

Health and Personal Care Stores

STAT

OCTOBER 22, 2024

Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. The FDA still has to make a decision on whether to officially place semaglutide on the lists.

Compounding

STAT

OCTOBER 23, 2024

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

Compounding

STAT

DECEMBER 4, 2024

But documenting the differences between Zepbound and Wegovy in a rigorous way might allow Lilly to make marketing claims about Zepbound’s superior efficacy.   A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S. That, in turn, could help the company gain market share against Novo. 

Compounding

National Association of Boards of Pharmacy

MARCH 22, 2024

Food and Drug Administration (FDA) has issued two draft interim guidance documents that address the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Documentation

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation

National Association of Boards of Pharmacy

DECEMBER 4, 2024

After years of development, revised compounding standards from United States Pharmacopeia (USP) became effective on November 1, 2023. USP Chapter <795> focuses on nonsterile compounding, with updates aimed at improving quality, safety, and consistency.

Compounding Pharmacies

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation

European Pharmaceutical Review

JULY 24, 2023

A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories. It requests that compounding laboratories adhering to the programme send samples of it. These are documented and their root cause is sought.

Compounding

PharmaTech

DECEMBER 11, 2023

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

Compounding