FDA issues guidance documents on labeling drug identity, constituents

Regulatory NewsRegulatory News | 13 September 2022 |  By 

The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the guidance document addresses the statement of identity and drug strength for OTC products and the other relates to the quantification of sodium, potassium and phosphorus and prescription and OTC drugs.
Identify and strength labeling
In draft guidance issued on 8 September 2022, FDA offered recommendations for the content and format of the required statement of identity and drug strength, both of which must appear in a prominent way on the principal display panel (PDP) for all human nonprescription drug products.
“Consistent content and format of the statement of identify and drug strength may aid consumers in comparing different nonprescription drugs and assist consumers in selecting an appropriate product,” FDA said in a statement.
The statement of identity includes the drug’s established name and a statement of its general pharmacological category or its intended principal action. OTC monograph drug products should use the statement of identity contained in the monograph. However, if the OTC monograph statement of identity is not consistent with the draft guidance, FDA does not intend to take action against companies who follow the guidance, provided the drug product is marketed in compliance with all other applicable statues and regulations, including other requirements of the OTC drug monograph.
The draft guidance defines the established name as the official name designated by section 508 of the Food, Drug, and Cosmetic Act. Drugs that do not have an official name but are recognized in an official compendium, such as the United States Pharmacopeia (USP), should use the official title in the compendium. For drugs that do not fall into either category, the established name should be the “common or usual name” of the drug, according to the guidance.
For nonprescription drug products that are a mixture of two or more active ingredients, and which lack of a USP drug product monograph, FDA suggests using the USP drug substance monograph title for each active ingredient and listing them in alphabetical order.
FDA recommends that the statement of identity be presented in bold face type and be placed directly to the right or directly below the “most prominent display” of the proprietary name in the PDP. The drug strength should also be in bold face type and should be listed immediately after the statement of identity, according to the agency.
Public comments on draft guidance on the statement of identity and strength should be identified with docket number FDA-2022-D-1837 and sent to regulations.gov by 8 November 2022.
Sodium, potassium and phosphorous labeling
In a separate draft guidance document, also issued on 8 September 2022, FDA provided recommendations on quantitative labeling of sodium, potassium and phosphorus in human OTC and prescription drug products.
The guidance applies to oral and injectable drugs containing at least 5 mg of sodium, potassium, or elemental phosphorus per maximum single dose. “The presence of sodium, potassium, and phosphorus in quantities less than 5 mg is not expected to be clinically significant relative to dietary intake, even in patients taking several nonprescription and prescription drugs,” FDA wrote in the draft guidance.
Since patients with certain conditions, such as heart failure, hypertension, or chronic kidney disease, are advised to restrict their dietary intake of sodium, potassium and/or phosphorus, FDA said quantifying these constituents in drug labeling could help patients better determine their daily intake. “Quantifying these constituents in drug product labeling as recommended in this guidance may also allow health care providers and patients to select drug products with lower amounts of these constituents when such alternatives are available,” FDA wrote in the guidance.
The drug label should include the total amount of the constituent, whether it is present in an active or inactive ingredient. The amount of the sodium, potassium, or phosphorus in a drug should be determined from the product’s formulation information, according to FDA. “For example, if a drug product contains both naproxen sodium and trisodium citrate, the total amount of sodium in the drug product from both compounds should be stated,” the agency wrote.
The agency recommends that manufacturers provided quantitative information per dosage unit for consistency across products.
The agency noted that it may be difficult to quantify the constituents in some biological products, such as cellular therapies, and manufacturers should discuss how best to do it with the appropriate FDA review division.
Public comments on the draft guidance on sodium, potassium, and phosphorus labeling should be identified with docket number FDA-2022-D-0528 and sent to regulations.gov by 8 November 2022.
Draft guidance: Statement of identity and strength
Draft guidance: Sodium, potassium, and phosphorus labeling


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