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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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Chemotherapy and Compounding – What You NEED to Know

epicur

Epicur Pharma’s Advisory Council member Ann Donoghue, DVM, MS shares her personal perspective on the important relationship between veterinary oncology and compounded medications used in chemotherapy treatments. But compounding is not easy, it requires skill, training, and consistency.

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Pharma á la carte – 4/25/23

The Honest Apothecary

CALIFORNIA CONSIDERS CLASSIFYING FLAVORING AS “COMPOUNDING “ In a nearly unprecedented move, the state of California is considering treating “flavoring” of a prescription (such as a child’s antibiotic) as “compounding”, thus making the process more difficult and burdensome to pharmacies.

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Gilead’s COVID-19 drug Veklury falls short in WHO’s global trial

pharmaphorum

Gilead’s Veklury (remdesivir) has failed to produce an effect on hospital stay and mortality in COVID-19 patients in a large global trial, casting doubt on previous supportive study findings. According to the study the regimens have little or no effect on length of hospital stay or 28-day mortality, the WHO said.

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Extemporaneous Preparation with Unknown Stability

RX Note

Introduction Recently, you are assigned the task of updating extemporaneous preparation formulae at your hospital. USP General Chapter and and both describe compounded preparations that are required to be sterile or can be prepared as nonsterile. However, what should you recommend if stability data is unavailable?

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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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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog: Biosimilars

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).