FDA Rejects Bulk Compounding For Ephedrine Sulfate

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Nexus Pharmaceuticals LLC announced that the U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register that ephedrine sulfate should not be bulked by compounding facilities. Bulking is the practice of an outsourcing facility to “compound a drug using a bulk drug substance.”¹ The FDA explained that bulk compounding is allowed only where there is a drug shortage or “the bulk drug substance appears on a list” set by the FDA called “the 503B Bulks List.”² Section 503B refers to the portion of the Drug Quality and Security Act setting forth requirements when certain compounded products may be allowed.

On August 21, 2023, the FDA published its conclusion as to ephedrine sulfate that the FDA “now decided not to place [it] on the 503B Bulks List.”³ The FDA confirmed that companies including Nexus with its EMERPHED^® product already have FDA-approved products available for both the vial and syringe presentations of ephedrine sulfate, including “as a 5 mL single dose, prefilled syringe that contains 25 mg/5 mL (5 mg/mL) ephedrine sulfate, preservative-free, for intravenous administration, and as a 10 mL single dose, prefilled syringe that contains 50 mg/10 mL (5 mg/mL) ephedrine sulfate, preservative-free, for intravenous administration.”⁴

In its notice this week, the FDA also confirmed that “the products available as prefilled syringes are premixed formulations and do not require dilution prior to administration for their labeled indications.”⁵ The FDA concluded that “there is no clinical need for outsourcing facilities to compound using the bulk substance[] ephedrine sulfate” and “therefore we are not including these bulk drug substances on the 503B Bulks List.”⁶

“We are pleased that the FDA properly decided bulk compounding for ephedrine sulfate is not authorized,” said Chief Executive Officer and President, Usman Ahmed. “The FDA needs to continue to step up as a champion for compliance with the substantial restrictions Congress set forth for when compounded products may be tolerated.”

Nexus’ EMERPHED^® product is and remains available as an FDA-approved ephedrine sulfate product in both vial and syringe presentations. EMERPHED^® was the first 10 mL ephedrine sulfate prefilled syringe approved by the FDA.

About EMERPHED^® (ephedrine sulfate injection)

INDICATIONS AND USAGE

EMERPHED^® (ephedrine sulfate injection) is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

WARNINGS AND PRECAUTIONS

EMERPHED^® (ephedrine sulfate injection) can cause pressor effects with concomitant use with oxytocic drugs. It can also cause tachyphylaxis with repeated administration of ephedrine.

CONTRAINDICATIONS

None.

OVERDOSAGE

Overdose of EMERPHED^® (ephedrine sulfate injection) can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.

ADVERSE REACTIONS

Most common adverse reactions during treatment: nausea, vomiting, and tachycardia.

To report SUSPECTED ADVERSE REACTIONS, contact Nexus Pharmaceuticals at [phone] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Nexus Pharmaceuticals LLC

Nexus Pharmaceuticals LLC, a US-based healthcare company and certified diverse supplier, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor-intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most. For more information about Nexus Pharmaceuticals and its state-of-the-art manufacturing facility in Wisconsin, visit https://www.nexuspharma.net/project-tomorrow/.

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1} FDA Register, Vol. 88, No. 160, at 56838 (available at https://www.govinfo.gov/content/pkg/FR-2023-08-21/pdf/2023-17881.pdf).
² Id. at 56839.
³ Id.
⁴ Id. at 56840.
⁵ Id.
⁶ Id. at 56t843.