Beyond use dating for compounded pharmaceuticals

These beyond-use date limits may be exceeded when there is supporting valid scientific stability information that is directly applicable to the specific preparation (i.e., the same drug concentration range, p H, excipients, vehicle, water content, etc.).

See also the beyond-use dating information in the Federal law requires that manufactured drug products be labeled with an expiration date. The label on the container or package of an official compounded preparation must bear a beyond-use date.

Compounding is an integral part of pharmacy practice and is essential to the provision of health care.

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.Sewage, trash, and other refuse in the compounding area is to be disposed of in a safe, sanitary, and timely manner.Equipment is to be thoroughly cleaned promptly after use to avoid cross-contamination of ingredients and preparations.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.

Container–drug interaction is to be considered with substances such as phenolic compounds and sorptive materials (e.g., polypeptides and proteins).

Assurance of sterility in a compounded sterile preparation is mandatory.

See the table The compounder must avoid formulation ingredients and processing conditions that would result in a potentially toxic or ineffective preparation.

The compounder’s knowledge of the chemical reactions by which drugs degrade provides a means for establishing conditions under which the rate of degradation is minimized.

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.