The Thyroid Pharmacist

OCTOBER 7, 2022

Stevia is a natural sweetener derived from the plant Stevia rebaudiana , or “honey leaf,” which contains the sweet-tasting compounds known as steviol glycosides. It was first approved for use in the United States as a dietary supplement in 1995, and was later accepted as a sweetener in 2008. (8). What is Stevia? 2022;27(4):1362.

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ISPE

MARCH 29, 2023

Published June 2008. As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published June 2008. As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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Documentation Dosage Packaging Communication 52

ISPE

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Modernization of the FDA CDER Export Certificate Program.”

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The Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. Published 2008 Oct 21. Plecanatide is recommended by the ACG for overall symptomatic improvement in IBS-C patients. Parasit Vectors. 2008;1(1):40.

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Health and Personal Care Stores Chemotherapy Immunization Compounding 77

European Pharmaceutical Review

DECEMBER 13, 2022

The 1938 law effectively changed the focus of the Food and Drug Administration (FDA) from a policing agency to a regulatory agency tasked with overseeing the safety evaluation of new drug products. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. 5 Both compounds are limited to ≤0.1

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The Thyroid Pharmacist

JULY 29, 2022

I’ve seen a number of airborne toxins showing up as frequent triggers/exacerbating factors for my clients’ autoimmune conditions — mold, volatile organic compounds (VOCs), and artificial/synthetic fragrances, in particular. For cleaning products, only compounds need to be identified. Volatile Organic Compounds (VOCs) .

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Health and Personal Care Stores Compounding Immunization Labelling 52

The People's Pharmacy

JUNE 19, 2023

An article in the Journal of the American College of Cardiology (May 27, 2008) revealed that men with type 2 diabetes and erectile dysfunction were at greater risk of “cardiovascular events and deaths.” Sildenafil has been approved by the FDA to treat pulmonary hypertension. The brand name for this form of sildenafil is Revatio.

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Compounding FDA Insurance 71

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA.

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Documentation FDA Packaging Communication 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. The number of requirements in the revised Annex 1 has been significantly expanded from the original 2008 version and will come into force on 25 August 2023.

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ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

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Vaccines Compounding Documentation FDA 97

The Thyroid Pharmacist

OCTOBER 27, 2023

I started talking to Carter Black, RPh, my compounding pharmacist, about the symptoms I was experiencing, and he suggested that I have my adrenals tested. Garlic Oil Garlic is another natural compound that provides a host of health benefits. 2008 Jul;93(7):2559-65. Berberine Berberine is an amazing, multi-faceted herb.

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Health and Personal Care Stores Immunization Compounding Packaging 101

ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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Compounding Compounding Pharmacies Packaging FDA 52

The Thyroid Pharmacist

JANUARY 6, 2023

This medication is also FDA-approved for smoking cessation. Beyond antidepressants, I’ve seen other mood-altering drugs being used for refractory depression (depression that doesn’t respond to medication treatment), some “off-label,” others with FDA approval.

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The Thyroid Pharmacist

JULY 20, 2023

Just this year, the FDA approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia caused by chronic kidney disease, for adults who have been receiving dialysis for at least four months. [58] There are various iron salts, or compounds, and each of them have different levels of elemental iron in them. [63]

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Health and Personal Care Stores HIV Treatment and Prevention Agents Insurance Immunization 96