Impact Pharmaceutical Services

AUGUST 9, 2022

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. During the last year, IMPACT has submitted several FDA meeting packages for this consultant as well.

FDA 40

FDA Packaging Documentation 40

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.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

Pharmacy Friday Pearls

SEPTEMBER 23, 2022

Four factor prothrombin complex concentrate (4F-PCC) is FDA approved to reverse vitamin K antagonists (VKAs) such as warfarin in adult patients with acute major bleeding or a need for an urgent surgery/invasive procedure. Dosing According to Package Insert. Kcentra (prothrombin complex concentrate [Human]) [package insert].

Packaging 40

Packaging Hospitals FDA 40

Pharmacy Friday Pearls

MARCH 9, 2022

It is important to note that at present, Anavip ® is only FDA approved for North American rattlesnake envenomations, even though it is expected that it is safe and effective to use for copperhead and water moccasin envenomations as well. Crofab ® [package insert]. Anavip ® [package insert]. in the treatment group vs 7.4

Immunization 40

Immunization Packaging Labelling FDA 40

The Checkup by Singlecare

SEPTEMBER 28, 2023

Follow these steps to try nasal irrigation for congestion: Prepare the nasal rinse solution by mixing saline with distilled water per the package instructions. The FDA recently announced that the oral version of phenylephrine, a popular ingredient in some decongestants, is ineffective. Controlled Clinical Trial (2013) Vitamin C.

Compounding 105

Compounding Immunization Mayo Clinic Dosage 105

ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Invest in a High-Quality Portable Air Filter. Published 2018 Jul 2. doi:10.1038/s41598-018-28362-5.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. Sleep issues: I like to recommend Epsom salt baths, which contain magnesium that is absorbed through the skin (1 cup of salts per tub – follow package instructions, and don’t overdo it!), Published 2013 Dec 26. Adv Exp Med Biol. 2019;1182:1-37.

Health and Personal Care Stores 99

Health and Personal Care Stores Immunization Compounding Packaging 99

The Checkup by Singlecare

DECEMBER 1, 2023

Plan B prescribing information shared by the Food and Drug Administration (FDA) lists heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), dizziness (10%), and headache (10%) as the most commonly reported side effects in original clinical trials of Plan B. Plan B can be taken with or without food.

FDA 90

FDA Mayo Clinic Dosage Controlled Substances 90