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What compounding pharmacies need to know about USP 795 guidelines on nonsterile drug preparations

Nonsterile drug compounding, which refers to formulating medications that patients drink, swallow or apply to the skin, is the most common kind of drug compounding done in community and hospital pharmacies. Despite the nonsterile designation, preventing contamination is still a key part of compliance with legal and professional standards, such as those described in the U.S. Pharmacopeia and enforced by the FDA and state pharmacy boards.

USP 795 is a chapter of guidelines to help ensure safe and quality compounding of nonsterile pharmaceutical preparations for humans and animals. The document serves as a reference that defines the responsibilities of the compounder and establishes preparation protocol, storage conditions, special counseling considerations, and other important criteria beyond standard pharmacy practice.

The guidelines define terminology essential to nonsterile compounding. USP 795 also outlines good habits and practices in compounding nonsterile pharmaceutical preparations to ensure patient safety while preserving preparation purity, potency and efficacy. This also includes defining specifications for compounding facility design, storage and handling requirements and packaging.

Documentation is one of the most important elements to supporting compliance for compounding pharmacies, and USP 795 identifies the documentation required in maintaining good compounding records. Key elements of the compounding record include:

• The master formulation record
• The compounding record
• Standard operation procedures (commonly referred to as SOPs)
• The material data safety sheets
Such information ensures consistency and integrity in the compounding practice by providing an important record of batch preparations, beyond-use dates, compounders involved in the preparation and the concentrations of active ingredients and excipients.

All these features prove extremely useful should a preparation come into question and can help compounders pinpoint potential challenges, reduce errors and reproduce quality preparations.

Compounders will also find guidance for quality control, training and patient counseling.

The document outlines the three categories of nonsterile compounding, which vary in terms of graduated degree of skill, training and calculation complexity:

• Simple: While simple compounding requires the least amount of skill and complexity, compounders must still practice certain compounding habits, exercise appropriate technique, and take the appropriate measures to guarantee the concentration of active ingredients and excipients are accurate. Examples of simple preparations include captopril oral solution and indomethacin topical gel.
• Moderate: This category involves a higher level of skill than simple compounding and often employs calculations and/or special procedures to ascertain exact quantities of active ingredients and excipients. Examples of such preparations include morphine sulfate suppositories and diphenhydramine troches.
• Complex: This final category demands the most intricate level of skill and may require special training. Compounders must utilize special techniques, procedures, tools, and practices to develop pharmaceutical products. Examples of such preparations include transdermal dosage forms and modified-release preparations.
The Hasson Law Group recommends that all compounding pharmacies conduct periodic audits for compliance with FDA regulations and USP guidelines and have documentation in place to support protocols and training.

If you have questions about compliance with federal and state laws and regulations that govern the practice of compounding pharmacies, contact Hasson Law Group.

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    Hasson Law Group LLC

    The Hasson Law Group, LLP, is an Atlanta, GA law firm dedicated to two principal practice areas: winning high stakes disputes in the areas of business litigation, insurance recovery, and complex criminal defense, and tax, corporate and regulatory law mechanisms affecting family businesses, tax-exempt organizations and the individuals who support or serve them.

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