Zdrowie i gospodarka · 17/10/2003

Iron-Containing Supplements and Drugs: Label Warning Statement Requirements; Small Entity Compliance Guide; Availability

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) entitled "Iron- Containing Supplements and Drugs: Label Warning Statements; Small Entity Compliance Guide" to revise and update an earlier SECG entitled "Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements; Small Entity Compliance Guide." The revised SECG is being issued in response to the withdrawal, in part, of a final rule. The SECG is intended to set forth in plain language the requirements for label warning statements for iron-containing dietary supplement and drug products in solid oral dosage form and to help small businesses understand these requirements.