Medical professionals only prescribe compounded medications in situations where the commercial form of the drug fails to address the patient’s specific needs. If you have any questions about the formulation of your compounded medication, or why you need a compounded drug product, speak with your doctor or medical professional who prescribed the item. If you are apprehensive about taking a compounded medication, ask your prescriber to consider the commercial version of the drug and whether or not this could be an appropriate option for you. You may also ask your prescriber to provide any evidence that the compounded item will produce a better outcome than the commercial item.

Standards for drug compounding are also published by the United States Pharmacopeial (USP) Convention. USP is a private, nonprofit agency designed to establish definitions for the chemical purity of medications and set practice standards. Specifically, the USP guidelines pertain to identity, quality, potency, and purity of the medications, supplements, and food items involved in drug compounding. Such guidelines are distinctly relevant to compounding pharmacists.

USP General Chapter <797> is a nationally recognized set of guidelines that define the accepted practices for processing, testing, and verifying all compounded sterile drugs. It outlines instructions for avoiding microbial contamination and other problematic variances in compounded products. USP 797 guidelines apply regardless of location (may include hospitals or community pharmacies) or the types of medical professionals practicing compounding (pharmacists, pharmacy technicians, nurses, etc.).

USP General Chapter <800> is the updated set of USP guidelines for procedure and quality standards of hazardous drug handling. The purpose of this update is to reduce exposure of health care providers to hazardous drugs. Such efforts encourage employee safety, patient safety, and environmental protection. Released on February 1, 2016, USP 800 guidelines will be officially enacted on July 1, 2018. The existing list of drugs classified as hazardous can be located on the website for the National Institute for Occupational Safety and Health (NIOSH).

Observance of USP guidelines is required nationally as the minimum standard of operation in pharmacies.

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Standards for drug compounding are also published by the United States Pharmacopeial (USP) Convention. USP is a private, nonprofit agency designed to establish definitions for the chemical purity of medications and set practice standards. Specifically, the USP guidelines pertain to identity, quality, potency, and purity of the medications, supplements, and food items involved in drug compounding. Such guidelines are distinctly relevant to compounding pharmacists.

USP General Chapter <797> is a nationally recognized set of guidelines that define the accepted practices for processing, testing, and verifying all compounded sterile drugs. It outlines instructions for avoiding microbial contamination and other problematic variances in compounded products. USP 797 guidelines apply regardless of location (may include hospitals or community pharmacies) or the types of medical professionals practicing compounding (pharmacists, pharmacy technicians, nurses, etc.).

USP General Chapter <800> is the updated set of USP guidelines for procedure and quality standards of hazardous drug handling. The purpose of this update is to reduce exposure of health care providers to hazardous drugs. Such efforts encourage employee safety, patient safety, and environmental protection. Released on February 1, 2016, USP 800 guidelines will be officially enacted on July 1, 2018. The existing list of drugs classified as hazardous can be located on the website for the National Institute for Occupational Safety and Health (NIOSH).

Observance of USP guidelines is required nationally as the minimum standard of operation in pharmacies.

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Approximately 7,500 pharmacies, out of the 56,000 total pharmacies currently operating in the United States, are specifically devoted to drug compounding. This disparity places a high demand on compounding pharmacies, and that means pharmacists in these establishments work primarily on compounding specific drugs that cannot be obtained elsewhere. Items produced in these facilities have a higher probability of incorporating sterile and nonsterile dosage forms. It should also be noted that compounding can be completed in hospital pharmaceutical settings and alternate health care establishments.

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Although many pharmacies are qualified to carry out some degree of non sterile drug compounding, the majority of compounding takes place in pharmacies equipped with specific instruments and professionals who have been trained in the practice. Drug compounding procedures can be utilized for products that do not require sterile compounding (such as liquids, ointments, creams, or capsules), or they can be utilized for items where sterile compounding is critical (medications injected into bodily tissue, blood, or applied in the eyes).

All licensed pharmacists are taught the fundamental concepts necessary to carry out simple compounding procedures. Furthermore, the majority of pharmacies possess basic drug compounding instruments such as graduated cylinders, balances, mortars and pestles, spatulas, and ointment slabs. These items can be used, respectively, to measure liquids, weigh solids, grind items, combine substances, and manipulate products. This assortment of basic pharmaceutical resources allow compounding pharmacists to routinely produce non sterile compounded medications for prescribers.

Drug production can be classified as traditional compounding, pharmaceutical compounding, or manufacturing. Traditional compounding is the formulation of drugs that address all elements of the approved prescription and can be administered immediately to the patient. Pharmaceutical compounding is drug production carried out or monitored by a pharmacist who is authorized by the state board of pharmacy. Manufacturing is the large-scale assembly of medications, which have been previously approved by the Food and Drug Administration (FDA). Medications that are manufactured are then distributed to pharmacies, medical professionals, and other organizations who are approved by state and federal law to resell these items.
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Odulair is the only manufacturer of Mobile Compounding Pharmacies in the USA. When you buy from Odulair, there is no middle men. Odulair provides turn-key solutions to get your pharmacy current with USP 800 standards and guidelines.

Compounding is a process in which a licensed pharmacist manufactures a drug that addresses the specific needs of an individual patient. Compounding is typically carried out in situations where the comparable commercial drug does not meet the exact needs of the patient. The circumstances that might lead a patient to need a compounded drug could include a situation where the patient cannot tolerate some element of the commercial version of the drug, or the patient needs a drug that has been discontinued or produced in limited amounts.

The official definition for compounding, as stated by the US Pharmacopeia Convention (USP), is “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.”

The ways in which a compounding pharmacist can formulate medications for prescribed patient needs include but are not limited to:

Specified drug potency or dosage
Addition of palatable taste (generally intended for children or animals)
Removal of a non critical drug component that poses an allergy problem for the patient (typically lactose, gluten, or dye)
Conversion of drug medium from pill to liquid or vice versa for patients who are unable to swallow or experience stomach discomfort

Compounding pharmacists are capable of modifying medications to liquid forms, transdermal creams, topical ointments, or specified dosages. The practice of reproducing commercially available medication is not considered a form of pharmaceutical compounding and is prohibited by law.

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