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7 Things to Know About the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Final Rule

FDA’s Center for Drug Evaluation and Research (CDER) has finalized the rule, Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU). The rule is intended to increase options for drug companies to develop and market safe and effective nonprescription drugs, which are drugs that consumers can buy without a prescription. This rule has the potential to increase the types of drugs available to you without a prescription from your health care professional.

ACNU Final Rule Feature

Here are a few things to know about the final rule and how it could impact your nonprescription drugs:

  1. You can use nonprescription drugs without a prescription from a health care professional. For a long time, nonprescription drugs have provided an efficient, low-cost way for consumers to manage every-day health needs. Nonprescription drugs include drugs for allergies, pain, fever, and many more ailments. They can be purchased in many online and retail outlets, including pharmacies, grocery stores, and convenience stores.
  2. The label of a nonprescription drug is very important. The labeling of the nonprescription drug (including the Drug Facts label) must have information that you need to choose whether the drug is right for you (for example, active ingredients and warnings) and to use the drug product appropriately.
  3. ACNU stands for Additional Condition for Nonprescription Use. For a nonprescription drug product with an ACNU, you must complete an extra step to see if this drug is safe for you. Do not take this drug without completing this step. An example of an extra step could be a questionnaire to determine if the drug is right for you. If the drug is not right for you, you should talk to your doctor about other options.
  4. Nonprescription drugs with an ACNU are held to the same safety and effectiveness standards as all FDA-approved drugs. Just as prescription drugs have to go through a rigorous review for safety and effectiveness, so do nonprescription drugs, including nonprescription drugs with an ACNU.
  5. You should only use a nonprescription drug with an ACNU after you’ve completed the extra step. Do not take the drug without completing the extra step even if a family member bought the drug because the drug is not intended for everyone.
  6. You will know a nonprescription drug has an ACNU because the front and back of the drug’s label will have information about the ACNU. There will be a statement on the front of the package to alert that the nonprescription drug has an ACNU, which may read, “You must complete an extra step to see if this drug is safe for you before you use it. Do not take this drug without completing this step. See the Drug Facts labeling for more information.” The Drug Facts label is usually found on the back of a drug’s packaging and will have instructions about where to find information about the ACNU.
  7. Currently, there are no approved nonprescription drugs with ACNUs. We will provide additional information when FDA approves the first nonprescription drug with an ACNU. Today’s rule does not impact nonprescription drugs marketed under an approved marketing application or over-the-counter monograph.

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