The FDA Law Blog

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 59

Packaging Documentation Compounding 59

The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? affected by a shortage).

Compounding 52

Compounding Insurance Insurance Coverage FDA 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical compounding is a method of preparing personalised medications for patients by mixing the individual ingredients in the exact strength and dosage form required by the patient. Discover the top pharmaceutical compounding companies in contract marketing. Benefits of pharmaceutical compounding. Excipients.

Compounding 40

Compounding Compounding Pharmacies Sterile Compounds Dosage 40

The FDA Law Blog

SEPTEMBER 11, 2024

FDA says that highly potent compounds – again, as defined in ICH M7(R2) – pose risks below that limit. We note that the other FDA guidance document on nitrosamines addresses NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5

FDA 105

FDA Documentation Compounding 105

pharmaphorum

OCTOBER 21, 2021

It can be given to patients who have the most debilitating form AHP, with four or more severe attacks a year, according to a final appraisal document from NICE, which reverses an earlier position that the drug should not be made available by the NHS. It was approved by the European Medicines Agency (EMA) last year.

Documentation 98

Documentation Compounding Hospitals 98

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The agency issued 62 warning letters and 23 import alerts related to drugs, excluding compound-related actions.

FDA 98

FDA Documentation Compounding Pharmaceutical Companies 98

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. 3 Moreover, some studies have suggested that co-administration of these compounds can modulate the effects of one another at a receptor level.

Compounding 98

Compounding Documentation Insurance Immunization 98

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. It is also developing registration documents for approvals in Europe, with submission expected in the fourth quarter of this year.

FDA 59

FDA Compounding Pharmacies Labelling Compounding 59

Omnicell

SEPTEMBER 5, 2022

Mark Neuenschwander Founding Director, THRIVCoalition.org Seminal research from 1997 on IV compounding discovered that 9 percent of manually compounded sterile preparations had incorrect ingredients and/or volumes. Worst yet, 74% of all respondents were aware of at least one pharmacy compounding error in the last 12 months.

Compounding 52

Compounding Sterile Compounds Documentation Compounding Pharmacies 52

The Checkup by Singlecare

APRIL 17, 2024

According to Dr. Bonza, these requirements might include a documented diagnosis of Type 2 diabetes mellitus and confirmation with a medical test. Look into compounded options (but be careful). Some people received coverage for Type 2 diabetes, but not many for weight loss.

Insurance 98

Insurance Insurance Coverage Compounding Pharmacies Compounding 98

The Checkup by Singlecare

DECEMBER 28, 2023

In some cases, the weight-loss medication offered is neither brand-name Ozempic nor Wegovy but rather a compounded version of semaglutide. The FDA has urged consumers to use caution when taking medication from these compound pharmacies. Some providers may require lab tests or documentation of previous weight loss efforts.

Insurance 104

Insurance Insurance Coverage FDA Documentation 104

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% All top 20 biopharmaceutical companies recorded positive compound annual growth rates (CAGRs) in revenue during 2017–21, with BioNTech (319%) and Moderna (208%) leading thanks to their Covid-19 vaccine franchises.

Vaccines 108

Vaccines Documentation Compounding FDA 108

Pharmaceutical Technology

SEPTEMBER 7, 2022

Compounding services. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs. Speciality care.

Documentation 45

Documentation Compounding 45

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. ISPE Good Practice Guide on Containment for Potent Compounds 4. Environmental monitoring is another important aspect of Annex 1.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Compounding 98

Omnicell

JANUARY 10, 2023

Compounding these challenges is that each vaccine brand requires different storage requirements with regard to temperature and beyond-use date (BUD) for each temperature type (frozen, refrigerated, and room temperature). The good news is that there may already be solutions embedded in your health system.

Vaccines 52

Vaccines Omnicell Documentation Compounding 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JUNE 23, 2022

The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection” and was awarded earlier this month.

Compounding 52

Compounding Documentation FDA 52

The Checkup by Singlecare

MAY 28, 2024

While L-theanine itself doesn’t contain caffeine, the two psychoactive compounds sometimes occur naturally together and are marketed as a combination in supplement form. Combining the two compounds can enhance cognition, increase alertness and focus, and reduce adverse caffeine side effects. Does L-theanine have caffeine in it?

Compounding 78

Compounding Documentation FDA 78

pharmaphorum

JULY 28, 2022

Supply chain challenges are compounded by the broader global picture, such as the war in Ukraine, the great resignation, and natural disasters. The extraordinary scenario of producing vaccines for a global pandemic led to a well-documented shortage of vials, stoppers, and syringes, and finding a solution is no easy task.

FDA 111

FDA Documentation Compounding Dosage 111

European Pharmaceutical Review

JUNE 27, 2022

A guidance document has been released to support these activities. A potential first-in-class compound to treat dengue fever is currently undergoing Phase I clinical development, as is a potential drug candidate for Cryptosporidium infection, EDI048. LXE408 is currently entering Phase II clinical development.

Vaccines 110

Vaccines Communication Documentation Compounding 110

OctariusRx

FEBRUARY 20, 2023

If you read my post in December about How Much Does Compliance Cost , you know that not following proper processes and poor documentation can lead to patient harm and/or large fines from regulatory agencies such as the United States Drug Enforcement Administration (DEA).

Controlled Substances 79

Controlled Substances Documentation Compounding 79

The Checkup by Singlecare

MARCH 7, 2024

The compounding nature of medical debt becomes apparent when one bill leads to another, creating a snowball effect that can be overwhelming when financial resources are limited. Additionally, the aftermath of a medical emergency often involves ongoing treatments, compounding the strain on finances. Submit the required documents.

Insurance Coverage 98

Insurance Coverage Insurance Hospitals Documentation 98

Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Structure-based drug design has evolved, facilitating the exploration of novel chemical probes and lead compound potency, and molecular docking utilizes target structures to predict interactions and offers simplicity and speed. This shift from a linear to a network approach enhances the potential for one drug to target multiple sites.

Documentation 59

Documentation Process Improvement Compounding 59

ISPE

MAY 10, 2023

The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment, including background to safe working levels, mechanisms of exposure, and how exposure can be controlled.

Compounding 52

Compounding Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

MARCH 12, 2024

Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital. This involves keeping accurate and up-to-date records, documenting any deviations and corrective actions, and providing sufficient training to employees on GDP standards.

Documentation 98

Documentation Data Entry Communication Compounding 98

Pharmaceutical Technology

DECEMBER 15, 2022

From alcohols to quaternary ammonium compounds, each type of agent has a unique mode of action, with varying degrees of efficacy. In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. There are many other aspects to take into consideration.

Documentation 52

Documentation Compounding Communication Pharmaceutical Companies 52

ISPE

JUNE 21, 2023

The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without the need for the printing of paper test documents. If It Is Not Documented, It Did Not Happen.

Documentation 52

Documentation Data Entry Compounding FDA 52

The Checkup by Singlecare

JUNE 18, 2024

Flavonoids are compounds found in plants that are associated with heart and brain health. The weight loss benefits of legumes have been well documented. One of dietary fiber’s many benefits is that it supports cardiovascular health, explains Michelle Routhenstein, RD , a New York dietitian who specializes in heart disease.

Immunization 105

Immunization Documentation Compounding 105

The Checkup by Singlecare

JANUARY 3, 2024

The benefits are well-known—and well-documented in the popular press—but what about the potential downsides? That’s how it works its magic for blood glucose and weight loss. Strange side effects, such as Ozempic face and Ozempic butt have also made the news. Are tiredness and fatigue one of them?

Documentation 105

Documentation Compounding Dosage Labelling 105

Omnicell

SEPTEMBER 5, 2022

” This CE-accredited session for pharmacy and nursing discussed how COVID-19 is compounding complications of Substance Use Disorder, and shared best practices for diversion monitoring in order to refocus resources and revise schedules amidst COVID-19.

Omnicell 52

Omnicell Controlled Substances Hospitals Documentation 52

indispensable health

JANUARY 11, 2022

I spent time working in a community pharmacy and a compounding pharmacy. . “ My Name is Stephanie Everard and I am a Pharmacist Team Member with Indispensable Health ” — Stephanie Everard, PharmD. Stephanie, when did you become interested in pharmacy? I became interested in pharmacy in high school.

Drug Storage 52

Drug Storage Controlled Substances Documentation Compounding Pharmacies 52

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Manufacturing of (or with) high-potent compounds in adjacent suites may be possible with the appropriate engineering controls and risk assessments based on toxicity data.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

NOVEMBER 2, 2022

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

The Checkup by Singlecare

MAY 24, 2024

Can cats overdose on azithromycin ? Veterinary science has not determined a maximum dosage of azithromycin in animals. As a best practice, do not give the cat bigger doses than those prescribed by the veterinarian.

Immunization 95

Immunization Dosage Adverse Reactions Compounding Pharmacies 95

IDStewardship

AUGUST 29, 2022

For example, when a physician prescribes a non-formulary medication, there may need to be coordination with: your inventory technicians to figure out where to source this medication, IV technicians to provide appropriate compounding instructions to make the IV bag, and nursing staff to provide education on proper administration and monitoring.

Hospitals 130

Hospitals Dosage Documentation Compounding 130