Wholesaling by 503B Outsourcing Facilities - Lachman Consultants

What Constitutes Wholesaling by 503B Outsourcing Facilities?

The FDA released a guidance yesterday titled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here), which (as its title suggests) fully outlines what the Agency does and does not consider wholesaling by an outsourcing facility.  The examples of what a firm can and cannot do under the provisions of […]

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503B Outsourcing Facilities Batting 1 for 11 in This Round of Bulk Substances Reviewed

The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]

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FDA Guidance for Compounding Ibuprofen Suspension is in Effect Immediately!

With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]

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Bulk Drugs for Use in Compounding by 503B Compounders – Score: +2, -3

Outsourcing compounding facilities are those that register with the FDA as such under section 503B of the Federal Food Drug and Cosmetic Act.  According to the FDA, “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is […]

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FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

Compounding 5% Rule Enforcement Date Extended

For those facilities compounding drug products and distributing them out of state, the FDA has extended the statutory enforcement date.  On the Federal Register prepublication page this morning, the Agency announced that it is “extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products […]

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Compounded Drug Surveillance – Mitigation of Risk Is the Payoff

Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here)  which provides an overview of FDA’s Compounding Incidents Program.  It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]

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Compounding Committee to Evaluate Addition of 4 New Ingredients

The FDA’s Pharmacy Compounding Advisory Committee will be considering the addition of four new ingredients for use for inclusion on the bulk list for 503A compounders to utilize in the compounding of prescription drug products.  The four ingredients up for consideration are: Ammonium tetrathiomolybdate; Enclomiphene citrate; Ferric subsulfate; and Glutathione The Notice for the Advisory […]

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Caution Tape

Potential Serious Risks Associated with Compounded Nasal Ketamine

The FDA is warning healthcare professionals of potential risks associated with compounded ketamine nasal spray (here).  The Agency states that there is no approved ketamine nasal spray.  Hey, wait a minute! (you might say); I could have sworn that I read about a ketamine nasal spray approval?  Well, close!  The product you may be thinking […]

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Angry old couple in quarrel

The 5% Compounding Rule is Coming to a Head

On November 2, 2021, FDA posted an update to the Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Drugs (here).  FDA notes that it was sued by seven compounding pharmacies (503A compounders) in US District Court regarding the 5% limitation on the out of state distribution of compounded products by pharmacies in states that […]

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