US FDA publishes API-salt naming policy

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Pharmaceutical drug, Fda

Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).

Seasoned observers will know the US FDA has been developing its naming policy for API salts – which combine an ionisable drug and a counter-ion– since December 2013 following the implementation of the US Pharmacopoeia's (USP) monograph.

Last week, the regulator published its final guidance​ on the subject, deciding that new drugs will be named after their API alone – ‘newdrug’ and not ‘newdrug hydrochloride’ according to the FDA example – to minimize potential confusion.

The FDA said the policy “should help avoid medication errors that could result from a mismatch of established name and strength​” also suggesting it “will make it easier for healthcare practitioners to calculate an equivalent dose when transferring patients from one dosage form to another​.”

The guidance will apply to all new drugs, although the FDA said it will make exceptions on a case by case basis if the fact the ingredient is a salt is therapeutically important. Approved medicines will not be impacted unless there are specific safety concerns.

Medication errors

According to FDA data, more than 95,000 medication errors have occured in the US since the year 2000​. While it has no solid figures, the agency belives a significant proportion of thses mistakes are related to the drug name.

The FDA takes such concerns into consideration when reviewing the 400 or so drug name and labels submitted by drugmakers each year. The agency rejects around 100 each year for reasons of appropriateness, similar spelling to another currently marketed product, ambiguity in a drug name and/or identifier, or simply beacuse the proposed name is misleading.

Related news

Related products

show more

Eastern & Western Manufacturing Solutions

Eastern & Western Manufacturing Solutions

Piramal Pharma Solutions | 07-Dec-2021 | Technical / White Paper

The best manufacturing site for a product can change throughout the life cycle. When bringing new drugs to market, biopharma companies may benefit from...

Flexibility and capability in pre-filled syringes

Flexibility and capability in pre-filled syringes

Curia | 15-Nov-2021 | Technical / White Paper

Pre-filled syringes have risen in popularity in recent years but the pandemic’s impact on drug development, manufacturing and patient care has created...

LACTIUM®: dairy bioactive to soothe your pet

LACTIUM®: dairy bioactive to soothe your pet

Ingredia | 12-Oct-2021 | Infographic

Lactium® gives you the chance to better meet your pet’s needs for a more harmonious life together. Lactium® acts on the brain and has no side-effects,...

Related suppliers

Follow us


View more