Eye on FDA

AUGUST 2, 2022

The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. Violations this year so far were 9 and included risk presentation deficits (3 letters) Superiority Claims and Unsubstantiated Claims (2 each) and Promotion of an Unapproved Drug (1).

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Pharmaceutical Technology

JULY 26, 2022

The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

Labelling 122

Labelling Compounding 122

Express Pharma

NOVEMBER 1, 2024

Over 70 per cent of these conditions lack a cure and often go unnoticed, presenting a significant opportunity for drug repurposing in India. Streamlined regulatory pathways One of the biggest enablers of drug repurposing is the regulatory framework designed to expedite approvals for already-approved compounds.

Drug Development 111

Drug Development Compounding Generic Medicine Vaccines 111

ID Stewardship

OCTOBER 14, 2024

Read all about this in the product label here. More information on ganciclovir in the label here. Compounding sulbactam-durlobactam Admittedly I have never compounded this one myself, but it just sounds like an error waiting to happen as well as a considerable time commitment. Well, maybe not. Have another one?

Labelling 52

Labelling Compounding Packaging Hospitals 52

FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. 353b(a)(8). 353b(a)(8).

Compounding 52

Compounding Hospitals Labelling 52

Pharmaceutical Technology

JANUARY 23, 2023

Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. This lack of options and progression within this IBD patient subpopulation presents a clear unmet need and opportunity.

Labelling 59

Labelling Compounding Drug Development 59

RX Note

MARCH 23, 2023

Introduction Despite the shifting of pharmacy focus to pharmaceutical care, the practice of compounding pharmaceutical formulations remains an essential skill for pharmacists. Product should be labelled clearly and stored as recommended within the formula. Being a drug expert, we are expected to know them all.

Compounding 52

Compounding Health and Personal Care Stores Hospitals Dosage 52

Pharmaceutical Technology

DECEMBER 16, 2022

The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% The shrinking female population ages 12–54 years in the 5EU and Japan will dampen the extent of growth in diagnosed endometriosis cases.

Labelling 59

Labelling Compounding 59

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. Store all labels and leaflets in a locked room. How do you control premises to prevent cross contamination?

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

Ramblings of a pharmacist

SEPTEMBER 27, 2021

As I’ve been walking the shelves, I’ve been musing about the 2D data matrices that are present on every bottle. prefix is 21) Since the enactment of the DSCSA as part of the DQSA (Drug Quality and Security Act), data matrices have been a required component of labeling.

Compounding 52

Compounding Labelling 52

Quality Matters

MARCH 1, 2024

USP has a long-standing history of healthcare standards including those for compounding preparations that are tailored to meet the unique needs of patients who may not otherwise have access to their medications.

Labelling 52

Labelling Compounding 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 80

Health and Personal Care Stores Labelling Immunization Immunity 80

The Happy PharmD

JUNE 26, 2023

I’ve published several articles and presented poster sessions at national conventions. Furthermore, although the pharmacy labs tried to simulate a retail setting, they stressed compounding, calculations, and consultation. They typed labels, talked to doctors and patients, and focused on the daily number of prescriptions filled.

Hospitals 52

Hospitals Labelling Prescription Filling Pharmacy Management 52

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

The Thyroid Pharmacist

OCTOBER 7, 2022

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. Stevia is a natural sweetener derived from the plant Stevia rebaudiana , or “honey leaf,” which contains the sweet-tasting compounds known as steviol glycosides. What is Stevia? What Are the Benefits of Stevia?

Diabetes 98

Diabetes Immunization Immunity Labelling 98

The Thyroid Pharmacist

AUGUST 18, 2023

Benefits and Uses of Curcumin Turmeric’s medicinal benefits can mostly be attributed to compounds called curcuminoids. While most people with Hashimoto’s do have inflammation, only some will present with pain symptoms. Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study.

Dosage 98

Dosage Compounding Labelling Diabetes 98

GMPSOP

DECEMBER 6, 2024

All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately. Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine. formalin) present a threat due to vapors.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

The Thyroid Pharmacist

NOVEMBER 17, 2022

Enzymes are a form of protein present throughout the body. When someone is not properly digesting fats, they will often present with diarrhea, steatorrhea (fat in stools), cramping, bloating, and muscle cramps. Herbal Bitters includes: Ginger : The spicy warmth of ginger comes from gingerol and shogaol, compounds called gingeroids.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunization Immunity Compounding 98

The Thyroid Pharmacist

SEPTEMBER 6, 2023

Furnishings Furniture and carpeting can be a significant source of VOCs (volatile organic compounds), which are emitted as gasses from a variety of both solid and liquid sources. Coffee : Mold toxins can be present in some coffee, and I love Dave Asprey’s commitment to creating mold-free coffee.

Health and Personal Care Stores 85

Health and Personal Care Stores Packaging Labelling Compounding 85

Pharma in Brief

JANUARY 25, 2023

Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use. Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ). The FC’s decision has been appealed.

Biosimilars 52

Biosimilars Dosage Labelling Compounding 52

Proxsys Rx

DECEMBER 11, 2023

Compounding the problem for manufacturers is the Pharmacy Benefit Managers (PBMs) — third-party companies that function as intermediaries between insurance providers and the manufacturers. Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Labelling 52

The Thyroid Pharmacist

OCTOBER 28, 2022

Additionally, probiotics can help with many types of gut disorders, including small intestinal bacterial overgrowth (SIBO) , which is present in over 50 percent of people with Hashimoto’s. Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day.

Health and Personal Care Stores 105

Health and Personal Care Stores Immunization Immunity Grocery Stores 105

The Thyroid Pharmacist

OCTOBER 25, 2022

Fibrocystic breasts used to be labeled as a disease, but given how common they are, they’re now simply referred to as “fibrocystic breasts.” (7) If symptoms are severe and there are cysts present, a fine-needle aspiration may be performed, which may collapse the cyst and relieve discomfort. (13). Front Immunol. 2019;10:519. 2019.00519.

Compounding 61

Compounding Mayo Clinic Labelling Immunization 61

RX Note

JUNE 3, 2023

But, what you should know as a pharmacist is never limited to what have been presented here. Who are allowed to dispense or compound any poison for use in medical treatment? What are the legal requirements of labelling on a medication for a dispensed medicine by pharmacist? Familiarise yourself with references below.

Health and Personal Care Stores 40

Health and Personal Care Stores Chemotherapy Compounding Dosage 40

Proxsys Rx

MARCH 1, 2024

Compounding the problem for manufacturers is the Pharmacy Benefit Managers (PBMs) — third-party companies that function as intermediaries between insurance providers and the manufacturers. Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

Specialty Pharmacies 40

Specialty Pharmacies Hospitals Drug Pricing Labelling 40

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). 90% to 110% of the label claim).

Documentation 52

Documentation Dosage Labelling Data Entry 52

PharmaShots

APRIL 3, 2023

The safety profile was consistent with prior reported studies with no new safety signals & the results will be presented at an upcoming medical meeting & discussed with regulatory authorities The company has a comprehensive clinical development program in EC. APN-1607 & APN-005 for neurodegenerative disease. vs 9.2mos.)

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

The Thyroid Pharmacist

AUGUST 19, 2022

10) All three are required to be present for an autoimmune condition to manifest. pylori is present. pylori on the GI-MAP (not just what the lab showed to be positive), it ended up being 33 percent of people that had the pathogen present. I hope to share the full results of my review of the test results soon. I’ve had H.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunization Immunity Dosage 98

GMPSOP

OCTOBER 28, 2023

How to perform sampling in quality control process Sampling is the removal of a presentative portion of a lot to understand the lot’s composition and characteristics. GMP requires that all critical steps of manufacture are reliable or validated. This naturally includes laboratory test methods.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JULY 14, 2023

Biological contamination: “Biological contamination” refers to contamination by bacteria, yeasts, molds, viruses, or any other microorganisms that may be present in the product. They should never be topped up, used, or stored without labels and expiry dates.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

GMPSOP

APRIL 3, 2023

Sometime these are labelled as the “hidden factory”. – HPLC system calibration – the process of ensuring that an HPLC system produces accurate and reliable separation of chemical compounds. – Ensure systems for archiving of electronic data or notebooks are present. What is GMP documentation?

Documentation 52

Documentation Method Validation Compounding Data Entry 52

GMPSOP

MAY 31, 2024

The validation plan applies to all existing and new drug compounds and registered drug products or active pharmaceutical ingredients (APIs) for clinical use or sale. You should prepare a validation master plan to be presentable as a formal document suitable both as an internal guide and for scrutiny by a member of regulatory inspectors.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

The Thyroid Pharmacist

JULY 8, 2022

Selenium supplementation has also resulted in thyroid improvements in a few studies relating to Graves’ disease, and appears to also have a beneficial effect on Graves’ orbitopathy or ophthalmopathy (which is when antibodies are directed at the receptors presented behind the eyes, leading to a bulging eye appearance). (42). 2017;2017:2549491.

Dosage 59

Dosage Immunization Immunity Diabetes 59

pharmaphorum

MAY 26, 2022

For example, with skin conditions, textbooks, studies, and trial photos often present lighter-skinned individuals’ symptoms, which are bound to differ in darker skinned individuals. Throughout the pandemic, the issue of vaccine hesitancy was compounded by ethnic disparities. The pandemic brought imbalances into sharp focus.

Packaging 143

Packaging Vaccines Generic Medicine Labelling 143

European Pharmaceutical Review

JUNE 28, 2022

Class I epitopes from non-living vaccines can only be derived by cross-presentation of peptides generated during class II processing of extrinsic viral proteins in antigen presenting cells. presentation, but no robust evidence for this outcome has yet been published. Place exchange and release the peptide from the particle.

Vaccines 105

Vaccines Immunization Immunity Medical Schools 105

RX Note

FEBRUARY 23, 2023

Threadworm - Night-time perianal itching is the classic presentation Oral Thrush - Unusual in healthy adults Faecal Incontinence - Unintentional passage of stool Pouching Systems - Available as one-piece or two-piece systems Eye Dry Eye - Evidence of superior efficacy among any of the ophthalmic lubricants is lacking.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression.

Dosage 122

Dosage Labelling Communication Compounding 122