FADIC

OCTOBER 24, 2023

These include guidelines for the following: Acceptable ingredients Dosages Formulations Labeling requirements As long as a drug follows an OTC monograph, it can be marketed and sold without any further review or approval from the FDA. Labeling Labeling requirements also differ for prescription and OTC drugs.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Labelling Dosage 52

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

Compounding 52

Compounding Sterile Compounds Packaging Labelling 52

GMPSOP

NOVEMBER 6, 2022

These standards can only be used if they are standardized against primary standards using definitive methods that are published in pharmacopoeias, and national and international standards. Primary reference standards as indicated under definitions, are substances manufactured and tested to compliance by a certified source.

Labelling 52

Labelling Documentation Packaging Communication 52

GMPSOP

JUNE 28, 2024

Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Unplanned deviations Unplanned deviations may occur at any manufacturing stage, such as dispensing, processing, testing, packaging, holding, or storage.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

Packaging 59

Packaging Documentation Labelling Communication 59

GMPSOP

AUGUST 23, 2022

Risk management scope definition The purpose or objective of the application of risk management needs to be clearly understood. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? process change, product recall, labelling change, adverse event/safety reporting)?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

The Thyroid Pharmacist

NOVEMBER 11, 2022

It turns out that many of the ingredients in laundry detergent aren’t listed on the label (and can irritate one’s skin!), And definitely take advantage of their Black Friday/Cyber Monday sale, which runs from November 26 to December 2, 2022. It has completely changed our laundry routine. For Your “Relax and Chill” Cousin.

Labelling 98

Labelling Packaging 98

GMPSOP

MARCH 17, 2023

By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. QA Inspector found no defect on those. .

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Putting Patients First Blog

JULY 10, 2023

The NHC encourages the FDA to develop a process for collecting and adding new examples to the guidance package as the opportunity arises. Specifically, we would appreciate the definition of “clinical outcome assessment” to incorporate this guidance’s framing that they should aim to measure changes relevant to patients.

Communication 40

Communication Drug Development Packaging Labelling 40

GMPSOP

MARCH 4, 2023

The quality risk management framework is ingrained in its definition. Remember the definition? Packaging and labelling operations v. The risk possibility in the pharmaceutical industry is limitless. What is quality risk management framework? Risk threshold interpretation Risk score (1-4): Low Risk.

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. – GDP and GWP are each special parts of GMP. – GDP and GWP each have their legal definitions and regulations.

Labelling 52

Labelling Packaging Documentation Inventory Control 52

Pharma in Brief

AUGUST 3, 2023

This long-awaited update broadens the definition of advertising and promotional messages and activities, and requires a contextual analysis to determine whether a particular message or activity is promotional or non-promotional in nature. Definition of “general public”.

Labelling 52

Labelling Packaging Vaccines 52

FADIC

MARCH 22, 2024

Because antipyretics can also be found in many allergy, cold, cough, and flu products, patients should be advised to always read all medication labels prior to administration to avoid therapeutic duplications or possible medication overdose. Read the labels carefully and select the appropriate medication for your symptoms.

Immunity 100

Immunity Immunization Dosage Packaging 100

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). For foods that do not have established definitions and standards of identity (i.e., The description or name of the food (i.e.,

Labelling 52

Labelling Documentation Packaging 52

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Figures - Elemental iron and calcium content?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Ramblings of a pharmacist

OCTOBER 26, 2022

To all external observers, the medication looked legitimate – it bore a normal label, it was the right size, the product tracing documentation was received in good order. Biktarvy® and other HIV drugs are generally labeled to “dispense in original packaging” so the pharmacist never broke the seal on the bottle.

Documentation 40

Documentation Labelling Independent Pharmacies Community Pharmacies 40