Any substance or mixtures of substances intended to be used in the compounding of a drug preparation and furnishing pharmcological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body
Active Pharmaceutical Ingredient
Ingredients that are necessary to compound a preparation but are not intended or expected to cause a pharmacologic response if administered alone in the amound or cencentration contained in a single dose of the compounded prepartion.
- Added Substance
- (inactive ingredients, excipients, pharmaceutical ingredients)
The date after which a compounded preparation should not be used; determined from the date the preparation is compounded.
Beyond-Use Date (BUD)
Any ingredient used in the compounding of a drug prepartion, including any active ingredient or added substance that is used in its preparation.
A professional authorized by the appropriate jurisdiction to perform compounding pursuant to a prescription or medication order by a licensed prescriber
The preparation, mixing assembling, altering, packaging, labeling of a drug, drug-delivery device or device in accordance with a licensed practitioner's prescription, medication order, or initiative base on the practioner/patient/pharmacist/compounder relationship in the course of professional practice. Includes:
Prepartion of doseage forms for both humans and animals patients
Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
Reconstitution or manipulation of comerical products that may require the addition of one or more ingredients
Prepartion of drugs or devices for the purposes of or as an incident ro research (clinical or academic) teaching or chemical analysis
Preparation of drugs and devices for prescriber's office use where permitted by feder and state law
Any drug identified by at lease one of the following six criteria:
Teratogenicity or developmental toxicity
Reproductive toxicity in humans
Organ toxicity at low doses in humans or animals
New drugs that mimic existing hazardous drugs in structure or toxicity
The production, propagation, conversion, or process of a drug or device, either directily or indirectly, by extraction of the drug from substances of natural origin or by means of chemcial or biological synthesis. May also include any packaging or repackaging of the substance or labeling or relabeling of containers for resale by pharmacies, practintioners or other persons.
A compounded drug dosage form or dietary supplement or a divice to which a compounder has introduced a drug.
The extent to which a preparation retains, within specified limits and throughout its period of storage and uses the same properties and characteristic that it possessed at the time of compounding
A component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended. Examples inclue water, syrups, elixirs, oleaginous liquids, solid and semisolid carriers, and proprietary products.
What are the criteria used to determine overall classification of nonsterile compounding?
- Degree of difficulty or complexity of the compounding process
- Stability information and warnings
- Packaging and storage requirements
- dosage forms
- Complexity of calculations
- Local vs systemic biological diposition
- Level of risk to the compounder
- Potential for risk or harm to the patient
What are the categories of nonsterile compounding?
Making a prepation that has a USP compounding mongraph or that appears in a peer-reviewed journal article that contains specific quantities of all componenets, compound procedure and equipment, and stability data for that formulation with appropriate BUDs; or reconstituting ofr manipulating commericial producs that may require the addition of one or more ingredients as directed by the manufacture.
Examples of simple compounding
- Captopril Oral Solution
- Indomethacin Topical Gel
- Potassium Bromide Oral Solution
Making a preparation that requires special calculations or procedures (such as calibration of dosage unit mold cavities) to determine quantities of components per preparation or per individualized posage units or making a preparation for which stability data for that specific formulation are not available.
Examples of moderate compounding
- Morphine Sulfate Suppositories
- Diphenhydramine Hydrochloride troches
- Mixing tow or more manufacturer cream products when the stability of the mixture is unknown
Making a preparation that requires special training, environment, facilities, equipment, and produres to ensure appropriate therapeutic outcomes.
Examples of complex compounding
- Transdermal dosage forms
- Modified-release prepartion, some inserts and suppositories systemic effects
The compounder is responsible for compounding preparations of acceptable
- accordance with the prescription or medication order
1. Personnel are appropriately trained and are capable of performing and qualified to perform their assigned duties. Such training should be documented.
2. Compounding ingredients of the appropriate identity, purity, and quality are purchased from reliable sources and are properly stored according to manufacurer specifications orUSP standards
3. Bulk component comtainers are labeled with appropriate OSHA hazard communication labels and Material Safety Data Sheets are available to compoundering personnel for all drugs and chemicals used in compounding.
4. All equipment used in compounding is clean, properly maintained, and used appropriately.
5. The compounding enviroment is suitable for its intended purpose; and procedures are implemented to prevent cross-contamination, espcially when compounding with drugs that require special precautions.
6. Only authorized personnel are allowed in the immediate vicint of the drug compounding operations.
7. There is assurance that processes are always carried out as intended or specified and are reproducible.
8. Compounding condtions and procedures are adequate for preventing errors.
9. All aspects of compounding are appropriately documented.
10. Adequate procedures and records exist for investigating and correcting failures or problems in compounding, testing or the preparation itself.
General Principles of Compounding
The dose, safety, and intended use of the prepartion or device has been evaluated for suitablilty in terms of:
- The chemcial and physical properties of the componets
- Dosage Form
- Therapeutic appropriateness and route of administration including local and systemic biological disposition
- Legal limitation, if any
What should be taken into consideration when determining a BUD?
- Assigned Conservatively
- The nature of the drug and its degradation mechanism
- The dosage form and its componets
- The potential for microbial proliferation in the preparation
- The container in which it is packaged
- The xpected storage conditions
- The intended duration of therapy
BUD for nonqueous formulations
The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier
BUD for water-containing oral formulations
The BUD is not later than 14 days when stored at controlled cold temperatures
The BUD for Water-containing topical/dermal and Mucosal Liquid and semisolid formulations
The BUD is not later than 30 days