Remove 2018 Remove Compounding Remove Labelling
article thumbnail

Extemporaneous Compounding

RX Note

Introduction In 2018, the Ministry of Health Malaysia published the Good Compounding Practice as a guidance for compounding practices. Glass mortars are used for liquids , such as suspensions and solutions, and for mixing compounds that are oily or can stain. When poured into the container, the meniscus is marked. (A

article thumbnail

Extemporaneous Preparation with Unknown Stability

RX Note

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Extemporaneous Formulation

RX Note

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.

article thumbnail

Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

article thumbnail

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog: Biosimilars

FDA also suggests throughout the draft guidance that information gathering on device materials of construction and the manufacturing process, including chemical additives, processing aids, presence of cohort of concern compounds, etc., of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

article thumbnail

Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. LDN can be taken in the form of a compounded tablet, capsule, liquid, or transdermal formulation. It’s also best to work with a compounding pharmacy that can help you titrate your dose correctly.

article thumbnail

Drug Repurposing: Unlocking access to rare solutions

Express Pharma

Streamlined regulatory pathways One of the biggest enablers of drug repurposing is the regulatory framework designed to expedite approvals for already-approved compounds. For repurposed drugs, early-stage trials such as Phase 1 or 2 might be sufficient, provided there is existing safety data on the compound,” Vyas explains.