APPLICABLE DEFINITIONS
Compounding
(see
Pharmaceutical CompoundingNonsterile Preparations 795)Compounding involves the preparation, mixing, assembling, packaging, and labeling of a drug or device in accordance with a licensed practitioner's prescription of medication order under an initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
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Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
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Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients as a result of a licensed practitioner's prescription drug order.
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Preparation of drugs or devices for the purposes of, or as an incident to, research, teaching, or chemical analysis.
Categories of Compounding
The categories of compounding are intended to provide an understanding among compounders when different forms of preparations are compounded. It is to be understood that there are levels of training associated with each category. In the categories of compounding described below, certain criteria were used to determine the overall classification.
Manufacturing
Manufacturing involves the production, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction of the drug from substances of natural origin or by means of chemical or biological synthesis. Manufacturing also includes (1) any packaging or repackaging of the substance(s) or labeling or relabeling of containers for the promotion and marketing of such drugs or devices; (2) any preparation of a drug or device that is given or sold for resale by pharmacies, practitioners, or other persons; (3) the distribution of inordinate amounts of compounded preparations or the copying of commercially available drug products; and (4) the preparation of any quantity of a drug product without a licensed prescriber/patient/licensed pharmacist/compounder relationship.
Component
A component is any ingredient used in the compounding of a drug product, including any that are used in its preparation, but may not appear on the labeling of such a product. (See
Pharmaceutical CompoundingNonsterile Preparations 795 for additional definitions.)
Compounder
A compounder is a professional authorized by the state to perform compounding pursuant to a prescription order by a licensed prescriber.
TRAINING
All personnel involved in the compounding, evaluation, packaging, and dispensing of compounded preparations shall be properly trained for the type of compounding conducted. All training activities will be covered by appropriate standard operating procedures (SOPs) and documentation.
All compounders and all personnel involved in compounding must be well trained and must participate in current, relevant training programs. It is the responsibility of the compounder to ensure that a training program has been implemented and that it is ongoing. Standards of practice require that all employees be adequately trained in their job functions and that all of the training is properly documented. Steps in the training procedure will include the following:
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All employees involved in pharmaceutical compounding shall read and become familiar with Pharmaceutical CompoundingNonsterile Preparations 795, Pharmaceutical CompoundingSterile Preparations 797, and Pharmaceutical Calculations in Prescription Compounding 1160.
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All employees shall read and become familiar with each of the procedures related to compounding, including those involving the facility, equipment, personnel, actual compounding, evaluation, packaging, storage, and dispensing.
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The compounder shall meet with employees to review their work and answer any questions the employees may have concerning SOPs.
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The compounder shall demonstrate the procedures for the employee, and will observe and guide the employee throughout the training process. The employee will then repeat the procedure without any assistance from, but under the direct supervision of, the compounder.
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When the employee has demonstrated to the compounder a verbal and functional knowledge of the procedure, then and only then, will the employee be permitted to perform the procedure without direct supervision. However, the compounder should be physically present and should check off the final preparation.
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When the compounder is satisfied with the employee's knowledge and proficiency, the compounder will sign off on the documentation records to show that the employee was appropriately trained.
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The compounder shall continually monitor the work of the employee and assure that the employee's calculations and work are accurate and adequately performed. The compounder is completely responsible for the finished preparation. The compounder will answer any questions the employee may have concerning the SOPs.
PROCEDURES AND DOCUMENTATION
All significant procedures performed in the compounding area will be covered by SOPs and will be documented.
Procedures should be developed for the facility, equipment, personnel, preparation, packaging, and storage of compounded preparations to ensure accountability, accuracy, quality, safety (including access to Material Safety Data Sheets), and uniformity in compounding. Implementing SOPs establishes procedural consistency and also provides a reference for orientation and training of personnel.
Documentation enables a compounder, whenever necessary, to systematically trace, evaluate, and replicate the steps included throughout the preparation process of a compounded preparation.