How Many 503b Registered Pharmacies

In the Us, compounding is a practice by which an authorised person combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Those authorised to make compounded drugs include licensed pharmacists and physicians.

Compounded drugs are prescribed when a patient'southward specific needs cannot be met by a Us Food and Drug Assistants (FDA)-approved medication, such as if the patient is allergic to one of the inactive ingredients, or for an elderly patient who has problem swallowing a tablet and needs a medicine in a liquid grade or to mask the gustatory modality of a medication and so it is more palatable for pediatric patients.

Although pharma compounding is an old practice, it still makes the news: on August 6, a U.s.a. Commune Court upheld the FDA's March 2019 conclusion to exclude vasopressin from the 503B list of majority substances afterwards the compounder Athenex (Buffalo, NY, USA) challenged the decision.

Vasopressin is the active pharmaceutical ingredient in Endo Pharmaceuticals Inc's (Malvern, PA, USA) hypotension drug Vasostrict.

US police forbids compounding to make copies of commercially available drug products. Compounded drugs are not FDA approved, therefore confirming the safety, effectiveness or quality of the medicines produced has been a historic problem. The rubber and compliance of compounded drugs are covered in the BPOR article 'Fifteen per cent of 503B Compounding Outsourcing Facilities Accept Violated FDA Regulations' (B/POR, July 2018).

Effigy 1: 503B compounding outsourcing facilities' dosage form offerings

Source: GlobalData Contract Service Provider Database, accessed August 7, 2019 © GlobalData 2019

The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches with or without prescriptions to exist sold to healthcare facilities for office utilize just.

As Figure i shows, the dosage form most offered by 503B registered facilities is injectable, with 53 US facilities offer injectables compounding. This is followed by other sterile liquids (route of administration undisclosed), solid, semi-solid, and non-injectable sterile liquid dosage course compounding. This is an interesting tendency given the potential run a risk, equally sterile liquids including injectables have strict sterility requirements and must have few endotoxins: these are the dosage forms that, if not prepared correctly, are most likely to lead to infections and/or other astringent complications.

Sterile compounding is used for drugs that will be administered through an infusion, an injection, or directly into the eyes, whereas non-sterile dosage forms include ointments, creams, liquids, and capsules that are administered through routes where the aforementioned level of sterility is unnecessary. At least 75% of US hospitals outsource sterile compounding preparations to 503B facilities so that they can ensure stability, cope with drug shortages, obtain a fix-to-administer form of the drug, extend shelf life, or compensate for an inability to compound required amounts in-house.

A written report from the Department Of Health and Human Services indicates hospitals likewise rely on outsourcing to provide products with extended shelf lives and for which exact demand may be unpredictable ("High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Utilise Them," OEI-01-thirteen-00150, April 2013).

In that location are but 61 companies with 503B compounding facilities. About of these are private companies; just two are publicly owned: Harrow Health Inc (San Diego, CA, United states of america) and Athenex Inc (Buffalo, NY, Us).

The bulk of 503B compounding companies have only 1 The states facility (88%), with seven% and 3% of compounding companies owning 2 or 3 facilities, respectively.

Just ane company, PharMedium Services LLC (Lake Forest, IL, Us), owns four 503B compounding outsourcing facilities, which are located in Memphis, Cleveland, Dayton, and Saccharide State. PharMedium specialises in sterile preparations for hospitals, ambulatory surgery centres, integrated delivery networks, and grouping purchasing organizations.

The companies with iii facilities each are Primal Admixture Pharmacy Services Inc (Bethlehem, PA, US) and QuVa Pharma Inc (Sugar State, TX, U.s.). Key Admixture Pharmacy Services Inc has three facilities in Arizona, California, and Pennsylvania. The company too emphasises its sterile preparations such as pre-filled anaesthesia syringes and epidurals. QuVa Pharma Inc has 2 facilities in Texas and one in New Jersey. The company is a provider of ready-to-employ compounded intravenous (Iv) products.

It is a common theme that the compounding companies with the nearly facilities place a heavy emphasis on sterile preparations: aseptic procedures require specialised equipment and expertise that is expensive to acquire and/or employ merely will let the company to cope with the relatively loftier demand for compounded injectables.

The FDA plans to rent more inspectors for compounding facilities and to establish a Compounding Center of Excellence for training, which could mean that weather could become more than difficult for compounding pharmacies in future (B/POR, March 2019).

All of the information used for the above assay can be found on GlobalData's Contract Service Providers database, which provides comprehensive detail on CMO facilities and their services. Compounding can be selected nether the services search for further facility details.

Related study

Expert Insights: Fifteen Pct of 503B Compounding Outsourcing Facilities Have Violated FDA Regulations

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