Beyond use dating for compounded pharmaceuticals dating for dummies e book h33t 1981camaroz28

Areas used for sterile preparations are to be separated and distinct from the nonsterile compounding area (see Compounding areas are to be maintained in a clean and sanitary condition.Adequate washing facilities are to be provided, including hot and cold water, soap or detergent, and air driers or single-service towels.Sewage, trash, and other refuse in the compounding area is to be disposed of in a safe, sanitary, and timely manner.

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Special precautions are to be taken to clean equipment and compounding areas meticulously after compounding preparations that contain allergenic ingredients (e.g., sulfonamides or penicillins).

Equipment is to be of appropriate design and size for compounding and suitable for the intended uses.

The types and sizes of equipment will depend on the dosage forms and the quantities compounded (see , and equipment manufacturers' instruction manuals).

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.).

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.

The pharmacist's responsibilities in compounding drug preparations are to dispense the finished preparation in accordance with a prescription or a prescriber's order or intent and to dispense those preparations in compliance with the requirements established by the Boards of Pharmacy and other regulatory agencies.

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.

Areas designated for compounding have adequate space for the orderly placement of equipment and materials to prevent mixups between ingredients, containers, labels, in-process materials, and finished preparations.

The compounding area is also to be designed, arranged, used, and maintained to prevent adventitious cross-contamination.

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