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GOOD COMPOUNDING PRACTICES
This chapter is intended to provide information as a supplement to other relevant chapters. The following discussion is applicable to those engaged in compounding preparations in all pharmacies.USP29 It is expected that pharmacists or compounders engaged in the compounding of drugs will compound in conformance with applicable state and federal compounding laws, regulations, or guidelines.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 orderUSP29 under an initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
or manipulationUSP29 of commercial products that may require the addition of oneUSP29 or more ingredients as a result of a licensed practitioner's prescription drug order.
Preparation of drugs or devices for the purposes of, or as an incident to, research, teaching, or chemical analysis.
| Category 1 | Nonsterile—Simple Generally, the mixing of two or more  commercial products |
| Category 2 | Nonsterile—Complex Generally, compounding with the bulk drug substances or when calculations are required. |
| Category 3 | Sterile—Risk Level 1 (See Low-Risk Level in USP general chapter 797) |
| Category 4 | Sterile—Risk Level II (See Medium-Risk Level in USP general chapter 797) |
| Category 5 | Sterile—Risk Level III (See High-Risk Level in USP general chapter 797) |
| Category 6 | Radiopharmaceuticals Preparation of radiopharmaceuticals |
| Category 7 | Veterinary Preparation of veterinary pharmaceu- ticals |
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795 for additional definitions.)
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professional authorized by the state to perform compoundingUSP29 pursuant to a prescription order by a licensed prescriber.
mustUSP29 be familiar with all of the details of Pharmaceutical Compounding—Nonsterile Preparations 795, Pharmaceutical Compounding—Sterile Preparations 797, Pharmaceutical Calculations in Prescription Compounding 1160,USP29 and other applicable state or federal compounding guidelines or laws. In addition, the compounder mustUSP29 be responsible for the following:
authorized personnel shallUSP29 be in the immediate vicinity of the drug compounding operations;
mustUSP29 ensure that personnel engaged in compounding wear clean clothing appropriate to the type of compounding performed, e.g., coats, gowns, gloves, masks, shoes, aprons, or other items as needed for protection of personnel from chemical exposures and for prevention of drug contamination.
mustUSP29 implement procedures to prevent cross-contamination when compounding with drugs (e.g., penicillins) that require special precaution to prevent cross-contamination.
compounderUSP29 to ensure that a training program has been implemented and that it is ongoing. Standards of USP29 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:795, Pharmaceutical Compounding—Sterile Preparations 797, and Pharmaceutical Calculations in Prescription Compounding 1160.
training process.USP29 The employee will then repeat the procedure without any assistance from, but under the directUSP29 supervision of, the compounder.USP29
directUSP29 supervision. However, the compounder should be physically present and should check off the final preparation.USP29
the employee was appropriately trained.USP29
assure that the employee's calculations and work are accurate and adequately performed. The compounder is completely responsible for the finished preparation. The compounder willUSP29 answer any questions the employee may have concerning the SOPs.
compounding.USP29 Implementing SOPs establishes procedural consistency and also provides a reference for orientation and training of personnel.compounder,USP29 whenever necessary, to systematically trace, evaluate, and replicate the steps included throughout the preparation process of a compounded preparation.USP29
797, and aseptic processes shall be conducted in an area separate and distinct from the area used for the compounding of nonsterile products.
under appropriate temperature conditions (controlled room temperature, refrigerator, or freezer).USP29 The bulk chemicals shall be stored in a manner such that they are protected from contamination. All containers shall be properly labeled.
797, and Injections 1 for compounding technique applications.
preparationUSP29 shall be of appropriate design and capacity. The equipment shouldUSP29 be stored in such a manner as to protect it from contamination, and shall be located in such a place as to facilitate operations for its use, maintenance, and cleaning.
USP29 The equipment shouldUSP29 be of suitable composition such that the surfaces that contact components are neither reactive, additive, nor absorptive and therefore will not affect or alter the purity of the compounded preparations.
or testing of compounded preparations shouldUSP29 be routinely inspected, calibrated as necessary, and checked to ensure proper performance.
After use, the equipment should be appropriately cleaned. Extra care should be used when cleaning equipment used in compounding preparations requiring special precaution,USP29 e.g., antibiotics, cytotoxins, cancer drugs, and other hazardous materials. USP29 If possible, special equipment may be dedicated for such use or if the same equipment is being used for all drug products, appropriate procedures must be in place to allow meticulous cleaning of equipment prior to use with other drugs.
mustUSP29 first attempt to use USP–NF drug substances manufactured in an FDA-registered facility.
andUSP29 slaughtered in countries where bovine spongiform encephalopathy (BSE) and scrapie are known not to exist.
PREPARATIONUSP29 CONTAINERS
661 and Containers—Permeation 671. The compounder shall obtain written records from the supplier to show that the containers meet USP requirements.
797 and Pharmaceutical Compounding—Nonsterile Preparations 795. The use of commercially available presterilized containers is encouraged for sterile preparations.USP29
USP29 stock is used first.
shouldUSP29 ensure that there are written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity that they purport to have. These procedures should be available in either written form or electronically stored with printable documentation.USP29
that include a description of (1) components, their amounts, the order of component additives, and the compounding process; (2) the required equipment and utensils; and (3) the drug product container and closure system.USP29
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shouldUSP29 have established written procedures that will describe the tests or examinations to be conducted on the preparationUSP29 compounded (e.g., the degree of weight variation among capsules) to assure uniformity and integrity of compounded drug preparations.USP29
shouldUSP29 be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final compounded preparations. Factors that may cause variability include (1) capsule weight variation; (2) adequacy of mixing to assure uniformity and homogeneity; and (3) clarity, completeness, or pH of solutions.
shouldUSP29 be designed to prevent microbiological contamination of compounded drug preparationsUSP29 purporting to be sterile, and these procedures shall be followed. Such procedures shall include validation of sterilization processes (see Pharmaceutical Compounding—Sterile Preparations 797).
shouldUSP29 establish appropriate beyond-use dates determined either from available USP–NF monographs, appropriate testing, or from peer-reviewed literature.
shouldUSP29 adopt appropriate storage requirements as provided in Preservation, Packaging, Storage, and Labeling under General Notices and Requirements.
preparation label should contain information required by state and federal law and accepted standards of practice. [NOTES—(a) The compounder shall use the established name or distinct common name (cannot use the trademarked name of a manufactured product). (b) The compounder cannot indicate that the compounded product is therapeutically equivalent to a manufactured product. (c) The label should state that this is a compounded preparation. (d) The compounder shall not use an NDC number assigned to another product.]USP29
Preparations compoundedUSP29 in anticipation of a prescription prior to receiving a valid prescription should not be prepared in an inordinate amount. A regularly used amount should be prepared on the basis of a history of prescriptions filled by the pharmacy. These preparations shouldUSP29 be labeled or documentation referenced with the following:
preparations shouldUSP29 be dictated by their composition and sterility, e.g., stored in a clean, dry place under appropriate temperature conditions (controlled room temperature, refrigerator, or freezer.)USP29
shouldUSP29 examine the preparationUSP29 for correct labeling after completion of the compounding process.
and to provide formulation records and compounding records.USP29
preparationsUSP29 shall be kept for a period of time as set forth in the federal andUSP29 state laws or regulations. Such records shall be readily available for authorized inspection.
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preparationsUSP29 for a prescriber's office use only where permitted by federal and state requirements.USP29
Where compounding for office use is permitted, theUSP29 compounder shall compound the preparation for the soleUSP29 purpose of administration by or for the prescriber.
mustUSP29 be generated and a number may be assigned.
according to the guideline available for compounding of veterinarian products.USP29
COMPOUNDING PHARMACY GENERATED PRODUCTS
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