Articles

Supporting Pharmacy Compounding: APC’s Efforts on GLP-1s and Drug Shortages | Newsletter | Issue 14 | 2024

Supporting Pharmacy Compounding: APC’s Efforts on GLP-1s and Drug Shortages | Newsletter | Issue 14 | 2024

The Alliance for Pharmacy Compounding (APC) is an organization dedicated to supporting the practice of pharmacy compounding. Each year is dedicated to bringing compounding awareness and industry updates in support of continual improvement of patients’ lives. This year, MediZap is pleased to announce our sponsorship of APC. We are excited to support this organization as they continue their mission to promote and protect the practice of pharmacy compounding. APC has done significant work in addressing Drug Shortages and the compounding of GLP-1s. They have updated their statements on the rules governing compounding, FDA guidance, and the permissibility of compounding essential...

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Uncovered – New USP 797 Sterile Compounding Guidelines Insider Perspective | Newsletter | Issue 14 | 2024

Uncovered – New USP 797 Sterile Compounding Guidelines Insider Perspective | Newsletter | Issue 14 | 2024

As of Nov. 1st, 2022, USP 797, “Pharmaceutical Compounding - Sterile Preparations,” was published, and one year later, on Nov. 1st, 2023, compliance with these new regulations was enforced. Upon extensive review of new guidelines, the industry and subject matter experts across regulatory consulting were left with some open questions. Two of the most salient and common areas that colleagues within the 503A compounding pharmacy industry focused on were Beyond-Use Dates (BUDs) and Lot size restrictions. MediZap has been at the forefront of addressing these concerns and has worked to understand further and provide context and recommendations around these areas...

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Unlocking the Power of X-Rays: A Critical Examination of Terminal Sterilization Techniques for Pharmaceutical Drug Products | Newsletter | Issue 14 | 2024

Unlocking the Power of X-Rays: A Critical Examination of Terminal Sterilization Techniques for Pharmaceutical Drug Products | Newsletter | Issue 14 | 2024

Several emerging methods of terminal sterilization hold promise to become established techniques that adhere to pharmaceutical drug products over time. These technologies encompass X-Rays, ultrasonication, supercritical gases, ultraviolet light, pulsed light, microwaves, infrared radiation, and plasma. This article specifically examines X-Rays. Emerging sterilization technologies must satisfy several criteria to be considered suitable for product sterilization: The technology must achieve a Sterility Assurance Level of 10-6 or higher. Products must withstand the terminal sterilization conditions. Terminal sterilization within the final packaging must be attainable. Chemical residues as by-products of sterilization must not be produced.  Additionally, terminal sterilization technologies must:  Be sufficiently...

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Navigating the Complexity of Extractables and Leachables Studies in Drug Regulatory Compliance | Newsletter | Issue 14 | 2024

Navigating the Complexity of Extractables and Leachables Studies in Drug Regulatory Compliance | Newsletter | Issue 14 | 2024

Extractables and leachables (E&L) studies constitute a pivotal element of regulatory submissions aimed at validating product safety. The complexity of E&L investigations varies depending on the container-closure system and drug product under scrutiny. Selecting a Contract Research Organization (CRO) endowed with expertise is imperative for the meticulous generation of reliable E&L data. The ISO certification for contract research labs that conduct microbiology and analytical chemistry testing on pharmaceutical products is ISO/IEC 17025. This standard specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It applies to all organizations performing laboratory activities, regardless of the number of...

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