RX Note

AUGUST 13, 2025

Read and document refrigerator and freezer temperatures at least twice each workday (in the morning and before the end of the workday). Attached here is a 2007 article on " Room-temperature storage of medications labelled for refrigeration ". An example of a buffered probe is one immersed in a vial of liquid (e.g.

Drug Storage

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Documentation

Drug Patent Watch

JANUARY 22, 2025

Documentation and record-keeping : Manufacturers must maintain accurate and detailed records of their manufacturing processes, including batch records, quality control records, and training records. Read the full article on the role of GMP in generic drug manufacturing and how it ensures quality and safety: [link]

Documentation

Express Pharma

AUGUST 12, 2025

This article explores the necessity for such a resource, an Indian equivalent of the Orange Book, examining its potential benefits and far-reaching sector-wide impacts across the healthcare and pharmaceutical sectors. Clear marking of innovator and approved generic products. Addressing potential concerns and implementation challenges.

Documentation

pharmacy mentor

JUNE 23, 2025

To help you understand what functionality is necessary for each of the 4 user types, we have created this PDF and the following article explaining each point. Secure Document Uploads – Protects sensitive health data while enabling necessary file sharing. Note Taking (AI) – Speeds up documentation with intelligent summarisation.

Health and Personal Care Stores

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. Accessed July 7, 2025.[link]

Medication Therapy Management (MTM)

Express Pharma

JUNE 19, 2025

Why this article? This article presents our consolidated perspective on the recurring challenges and deficiencies commonly encountered by Indian sterile drug manufacturing facilities, as observed through our engagements over the past eight years. Through our consulting engagements over the past eight years, RedLotus Pharmtech.

Documentation

Pharmaceutical Commerce

JUNE 18, 2025

27 of this year to meet the requirements, as long as they are making documented efforts to finalize data connections, of course. In fact, wholesalers and repackagers had until May 27, 2025 (following this day, full-unit traceability would be mandatory), a date that has officially passed. He can be reached at [email protected].

Drug Pricing

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

GMPSOP

JUNE 15, 2025

This article examines the various types of microorganisms commonly found in pharmaceutical production environments and explores the factors that influence their growth and survival. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month.

Pharmaceutical Manufacturing

PharmExec

AUGUST 7, 2025

It means data is: Structured and standardized (e.g.,

Communication

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

AUGUST 12, 2025

7015 FDA Advisory Committee Briefing Document: Columvi (glofitamab-gxbm) plus GemOx. Lei, PharmD, BCOP , Alana Hippensteele, Lead Editor Glofitamab-GemOx improves survival in transplant-ineligible patients with R/R DLBCL. J Clin Oncol. 2025;43(suppl 16). doi:10.1200/JCO.2025.43.16_suppl.7015 2025.43.16_suppl.7015 May 20, 2025.

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

European Pharmaceutical Review

APRIL 10, 2025

This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment.

Pharmaceutical Manufacturing

Pharma Marketing Network

APRIL 16, 2025

In this article, we explore how data-driven marketing empowers pharma brands to be more precise, predictive, and effective in their outreach efforts. As privacy regulations evolve, customer expectations change, and AI-driven technologies emerge, pharma marketers must adapt or risk becoming irrelevant.

HIPAA

Pharma Marketing Network

APRIL 29, 2025

This article explores how influencer marketing is reshaping pharma engagement strategies, why authenticity is non-negotiable, and which influencers are leading the conversation. Neurological Conditions Miles Levin Filmmaker who documented his battle with glioblastoma. Marisa Zeppieri Lupus patient and founder of LupusChick.com.

Diabetes

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

Express Pharma

JUNE 23, 2025

Most projects fail not in the lab, but in study design, regulatory interpretation, and documentation. This article explores why E&L studies go wrong and how to build a submission-ready package from protocol to final report. The reason?

Packaging

European Pharmaceutical Review

APRIL 14, 2025

That proposed Directive contains a similar regulatory framework for decentralised manufacturing (see prospective Articles 142-153). Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. But the UK framework will arrive first. One file per product.

Hospitals

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. link] articles/2018/12/dysmenorrhea-and-endometriosis-in-the-adolescent 4. American Pharmaceutical Association; 2025. December 2018. Pain Manag.

Pharmacy Technician

Proxsys Rx

APRIL 1, 2025

In a nutshell, says ProxsysRx 340B Optimization Manager Chance Spivey, the CE would have to pay retail prices first to allow for replenishment and THEN submit documentation like they do for 340B ESP (this time with even more claims info). Automate your 340B program with customized software streamlining documentation and reporting.

Specialty Pharmacies

PharmExec

AUGUST 8, 2025

This highlights a critical need for small to midsize biotechs to be able to generate the necessary documents to comply with the requirements. Even affluent countries with funds to pay top dollar for medications face administrative complexity and delays in simply importing products.

Communication

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. Schizophr Res. 2000;42(3):241-247.

HIV Treatment and Prevention Agents

Proxsys Rx

JULY 22, 2025

Upgrade your 340B documentation practices and technology Take every necessary step to ensure the accuracy of your records for 340B patient eligibility and drug dispensing. For more information on patient eligibility, click here to review our article on the topic. Make sure all patients given 340B prescriptions are eligible.

Specialty Pharmacies

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

Implement and meticulously document robust quality control and assurance processes internally. Justin Kozak The buzz around GLP-1 agonists like Ozempic and Wegovy is undeniable, fueled by social media virality and impressive clinical results. Subscribe Now!

Compounding

Pharmaceutical Commerce

AUGUST 12, 2025

Criminal networks exploit forged documentation , fake packaging, and corrupt distributors to infiltrate regulated supply chains with dangerous products. As is typical in such cases, the buyers were deceived by counterfeit pedigree documents and false assurances from the sellers. References 1. August 2, 2022. SafeChain Complaint.

Packaging

Pharmacy Times

JULY 18, 2025

Compliance with FDA guidelines, including documenting clinical differences and avoiding investigational GLP-1s, is essential for compounders. Even as I write this article, there is a breaking story of another round of such letters. It would also be expected that the reason would be documented in the patient’s chart.

Compounding

Pharma Marketing Network

MAY 9, 2025

This article uncovers the hidden elements of market access success, revealing what it takes to move from FDA approval to formulary inclusion, provider buy-in, and patient adoption. A value document submitted to payers outlining clinical data, economic models, and patient impact to support formulary inclusion. What is an AMCP dossier?

Packaging

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

PharmaTech

JULY 17, 2025

This summary of our extensive article on this topic—written by industry professionals Paul Pluta RPh, PhD, Alan Mancini RPh, Nishant Thakar, RPh, PharmD, and Varanya Chaiyaperm, RPh, PharmD—distills the essential technical and operational takeaways from a comprehensive, six-stage model of pharmaceutical compounding.

Compounding

FDA Law Blog: Biosimilars

APRIL 22, 2025

DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents. We also regularly blog on DEA administrative cases and procedures (see here ), and our HPM attorneys have authored articles (see here and here ) on the DEA hearing process.

Controlled Substances

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. Pharmacy (Basel). 2024;12(4):114.

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. JAMA Netw Open. 2019;2(7):e196700. doi:10.1001/jamanetworkopen.2019.6700 2018;153(7):663-670. doi:10.1001/jamasurg.2018.0040

Pharmacy Technician