Sterility expiration dating


15-Sep-2019 20:10

Compounders are to consult and apply drug-specific and general stability documentation and literature when available, and are to consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy when assigning a beyond-use date (see ).Beyond-use dates are to be assigned conservatively.The types and sizes of equipment will depend on the dosage forms and the quantities compounded (see , and equipment manufacturers’ instruction manuals).All equipment is to be constructed so that surfaces that contact pharmaceutical components, in-process materials, or finished preparations are not reactive, additive, or adsorptive to avoid altering the safety, identity, strength, quality, or purity of the preparation.Compounding is an integral part of pharmacy practice and is essential to the provision of health care.The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounder’s ability in the compounding facility to extemporaneously compound preparations that are of acceptable strength, quality, and purity.).The use of micropipets, electronic or analytical balances, or triturations or dilutions shall be considered when needed quantities are too small to accurately measure with standard equipment required by a state Board of Pharmacy.

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Adequate washing facilities are to be provided, including hot and cold water, soap or detergent, and air driers or single-service towels.

Compounders must be familiar with statutes and regulations that govern compounding because these requirements vary from state to state.), official standards, and relevant scientific data and information.

Compounders engaging in compounding should have to continually expand their compounding knowledge by participating in seminars, studying appropriate literature, and consulting colleagues.

When a manufactured product is used as the source of active ingredient for a nonsterile compounded preparation, the product expiration date cannot be used to extrapolate directly a beyond-use date for the compounded preparation.

However, a compounder may refer to the literature or to the manufacturer for stability information.

Some of the characteristics or criteria that differentiate compounding from manufacturing include the existence of specific practitioner–patient–compounder relationships; the quantity of medication prepared in anticipation of receiving a prescription or a prescription order; and the conditions of sale, which are limited to specific prescription orders.



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