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Extemporaneous Compounding

RX Note

Introduction In 2018, the Ministry of Health Malaysia published the Good Compounding Practice as a guidance for compounding practices. NOTE: When compounding a preparation using the contents of an ampoule , care should be taken to withdraw the solution using a filter needle to avoid incorporating glass particles into the compound.

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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.

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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.

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What is cross contamination in pharmaceutical industry

GMPSOP

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. – In 2019, the FDA publicly reprimanded 21 companies for cross-contamination.

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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. In addition to Skyrizi’s recent supplementary CD indication, both Tremfya and Skyrizi received US FDA approval in psoriasis in 2017 and in 2019, respectively.

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T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

GlobalData expects that the T2D market will see significant growth from 2019–29, with the 9MM having a total of $45.9 billion in sales in 2019, increasing to $136.2 billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. Correspondingly, the instances of promotion of an unapproved use has diminished and was last named as a violation in 2019.