Compounding
[1] The nature of patient need for such customization can range from absolute necessity (e.g. avoiding allergy) to individual optimality (e.g. ideal dose level) to even preference (e.g. flavor or texture).
Pharmacists continued to compound most prescriptions until the early 1950s when the majority of dispensed drugs came directly from the large pharmaceutical companies.
A physician may choose to prescribe a compounded medication for a patient with an unusual health need that cannot be met with commercially manufactured products.
These technologies use barcode scanning to identify each ingredient and gravimetric weight measurement to confirm the proper dose amount.
The workflow management systems incorporate software to guide pharmacy technicians through the process of preparing IV medications.
The robotic systems prepare IV syringes and bags in an ISO Class 5 environment, and support sterility and dose accuracy by removing human error and contamination from the process.
Although pharmacists who have undertaken further training to do complex compounding are not yet easily identified, the Board has been working to put a credentialing system in place.
Pharmacists preparing compounded products must comply with these requirements and others published in the Australian Pharmaceutical Formulary & Handbook.
These outsourcing facilities can be explicitly authorized by the Food and Drug Administration under specified circumstances, while being exempted from certain requirements otherwise imposed on mass-producers.
The FDA weighs the following factors in deciding whether it has authority to "exercise its discretion" to require approval for a custom-compounded drug product:[24] The DQSA amended the FFDCA to create a new class of FDA-regulated entities known as "outsourcing facilities" whose compounding activities "may or may not" be patient-specific based on individualized prescriptions.
In addition to being subjected to Food and Drug Administration inspections, registration, fees, and specified reporting requirements, other requirements of outsourcing facilities include: Poor practices on the part of drug compounders can result in contamination of products, or products that do not meet their stated strength, purity, or quality.
[29] It was further disclosed that in 2001–02, four people died, more than a dozen were injured and hundreds exposed after they received back-pain injections tainted with a common fungus dispensed by two compounding pharmacies in California and South Carolina.
[30] In August 2013 further reports tied to the New England compounding center said that about 750 people were sickened, including 63 deaths, and that infections were linked to more than 17,600 doses of methylprednisolone acetate steroid injections used to treat back and joint pain that were shipped to 23 states.
All lots of medications dispensed since May 9, 2013, made by Specialty Compounding, LLC of Cedar Park, Texas were recalled.
Drugs from compounding pharmacies can be cheaper or alleviate shortages, but can pose greater risk of contamination due in part to the lack of oversight.
"[27] The head of the FDA has recently requested the following authority from Congress:[34] Various ideas have been proposed to expand federal US regulation in this area, including laws making it easier to identify misuse or misnomered-use[35] and/or stricter enforcement of the longstanding distinction between compounding versus manufacturing.
