Compounding

In old times, medicines were prepared in pharmacies by a pharmacist under the guidelines and prescriptions of licensed practitioners, all the work related to medication carries out in pharmacies for example; 1) preparation, 2) mixing of ingredients, 3) assembling, 4) packaging and 5) labeling of a drug. This is called compounding or pharmacy compounding and is practiced under United States’ Pharmacopeia Convention (USP) guides. Compounding is categorized into two classes; 503A and 503B.

 

503A compounding

It is famous for traditional compounding and provides patient-specific medication with prescription individually. It facilitates medication within pediatrics, urology, hormone therapy, and dermatology. Whereas 503A does not provide medication in large batches to general offices, healthcare, and clinics. Products from 503A pharmacies are dispensed for an individual patient.

 

503B compounding

A 503B compounding pharmacy may also dispense patient-specific prescriptions, but is permitted to manufacture large-scale batches of a product that can also be sold to healthcare facilities for office administration.

Pharmacies that deliver office-use medication, follow a high level of safety standards and patient care is famous as 503B compounding. They usually deliver medication in large batches to healthcare, doctors, and clinics for general office use. 503B compounding is more trustworthy because they follow current good manufacturing practices (CGMP; FDA standards or regulations to evaluate drugs’ safety, quality, strength, and vice versa). Pharmaceutical manufacturers also practice drug manufacturing using CGMP guides, so CGMP guides are the primary standards implemented by FDA for compounding.

Historically, the development of 503B compounding within the US-based on quality assurance, cost-effectiveness, expedience, and safety levels. Back in 2012, the severe fungal infection and treatment of the infected people with preservative-free methylprednisolone (MPA) injections caused 64 recorded deaths. This injection was compounded by the New England Compounding Center in Massachusetts. This incident led to the development of a more sophisticated and quality-oriented compounding practice in the US. 

In 503B compounding the quality of each medication, batch ensures quality testing protocols before release. FDA very cautiously implemented quality standards for compounding because regulation of quality control is very important for drug products to assure the safety of patients at all levels.

503B compounding came into practice back in 2013, under the strict regulations of

• Compounding Quality Act

• Federal Food, Drug and Cosmetics Act and

• Drug Quality and Security Act

These acts gave a new shape to a compounding pharmacy. 503B compounding also performs potency testing, sterility, and endotoxin analysis of each batch of medication. To meet up with the day-to-day changing and developing drug therapies, 503B compounding works, maintains their services accordingly, and provides life-supportive and enhancing procedures. 

 

Sources

https://www.olympiapharmacy.com/blog/what-is-a-503b-pharmacy/

https://www.fagronsterile.com/newsroom/history-of-503b-outsourcing-facilities

https://www.empowerpharmacy.com/what-is-503b

https://www.compoundingcenter.com/blog/503a-503b-compounding-pharmacy

https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding

https://www.capspharmacy.com/en/quality/503a-and-503b.html

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