Pharmaceutical compounding practice
The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner–patient–pharmacist–compounder relationship in the course of professional practice. Compounding includes the following:
• Preparation of drug dosage forms for both human and animal patients,
• Preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observed prescribing patterns,
• Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients,
• Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis, and
• Preparation of drugs and devices for prescriber’s ofﬁce use where permitted by federal and state law.
Compounding can be as simple as the addition of a manufactured drug powder or as complex as the preparation of a multicomponent parenteral nutrition solution. In general, compounding differs from manufacturing in that compounding involves a speciﬁc practitioner–patient–pharmacist relationship, relatively small quantity of medication, and different conditions of sale (i.e., speciﬁc prescription orders).
Differences between compounding and manufacturing
Compounding is the act of preparing, mixing, assembling, packaging, and/or labeling a drug or device as the result of a practitioner’s prescription drug order or initiative based on the practitioner–patient–pharmacist relationship in the course of professional practice, or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observed prescribing patterns.
Manufacturing is the production, preparation, propagation, conversion, and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or independently through means of chemical or biological synthesis; the term includes any packaging or repackaging of the substance(s) or labeling or relabeling of its container and the promotion and marketing of such drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons.
• Pharmacists may compound, in reasonable quantities, drug preparations that are commercially available in the marketplace if a pharmacist–patient–prescriber relationship exists and a valid prescription is presented.
• Pharmacists may compound nonprescription medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by individual state boards of pharmacy.
• Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription, on the basis of a history of receiving valid prescriptions that have been generated solely within an established pharmacist–patient–prescriber relationship, and provided that the prescriptions are maintained on ﬁle for all such preparations dispensed at the pharmacy.
• Pharmacists should not offer compounded medications to other pharmacies for resale; however, a practitioner may obtain compounded medication to administer to patients, but it should be labeled with the following: “For Ofﬁce Use Only,” date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by hospitals to contract compounding pharmacies.
• Compounding pharmacies and pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services.
Compounding Facility and Equipment
Pharmacies that engage in compounding should have a designated area with adequate space for the orderly placement of the equipment and materials used in compounding activities. The pharmacist is also responsible for the proper maintenance, cleanliness, and use of all equipment involved in the compounding practice.
Only personnel authorized by the responsible pharmacist should be in the immediate vicinity of the drug-compounding operation. Any person with an apparent illness or open lesion that may adversely affect the safety or quality of a drug preparation being compounded should be excluded from direct contact with components, drug preparation containers, closures, in-process materials, and drug preparations until the condition is corrected or determined by competent medical personnel to not jeopardize the safety or quality of the preparation being compounded. All personnel who assist in compounding procedures should be instructed to report to the responsible pharmacist any health conditions that may have an adverse effect on drug preparations.
Pharmacists should possess the education, training, and proﬁciency necessary to properly and safely perform compounding duties at the level at which they are involved. All pharmacists who engage in the compounding of drugs should be proﬁcient in the art and science of compounding and should maintain that proﬁciency through current awareness and training.
Instruction for compounding pharmacists should cover the following:
• Proper use of compounding equipment such as balances and measuring devices, including guidelines for selecting proper measuring devices, limitations of weighing equipment and measuring apparatus, and the importance of accuracy in measurements,
• Pharmaceutical techniques needed to prepare compounded dosage forms (i.e., comminution, trituration, levigation, pulverization by intervention, and geometric dilution),
• Properties of dosage forms to be compounded and related factors, such as stability, storage considerations, and handling procedures,
• Literature regarding stability, solubility, and other physicochemical properties of the ingredients,
• Handling of nonhazardous and hazardous materials in the work area, including protective measures for avoiding exposure, emergency procedures to follow in the event of exposure, and the location of material safety data sheets (MSDSs) in the facility,
• Use and interpretation of chemical and pharmaceutical symbols and abbreviations in medication orders and in formulation directions, and
• Review of pharmaceutical calculations.
Personnel engaged in the compounding of drugs should wear clean clothing appropriate to the operation being performed. Protective apparel, such as coats or jackets, aprons, or hand or arm coverings, should be worn as necessary to protect drug preparations from contamination.
A clean laboratory jacket usually is considered appropriate attire for non-sterile compounding procedures. Work with hazardous materials, such as chemotherapeutic agents, may require the use of goggles, gloves, masks or respirators, double gowns, and foot covers; showers and eyewash stations should be provided. Clean room apparel is required for the compounding of sterile preparations in a controlled environment (clean room).