Tag: FDA Drug Labeling

ANTACIDS FDA REGULATION

Antacids are over the counter (OTC) drugs that helps with indigestion and heartburn by neutralizing stomach acids. Usually, antacids come in chewable tablets or liquid can be purchased from pharmacies without any prescription.

The active ingredients used in antacids vary depending on the type of brand. The most common ingredients are as below.

  • Alginate.
  • Aluminum hydroxide.
  • Calcium carbonate.
  • Magnesium carbonate.
  • Magnesium hydroxide.
  • Magnesium trisilicate.
  • Sodium bicarbonate.

To market Antacids in the US, below are process the company must comply with.

  • Drug establishment registration
  • Product listing
  • Label compliance
  • cGMP regulations

1. Drug Establishment Registration

Every domestic or foreign establishment that manufactures, repacks, or relabels drug products (including antacids) for the U.S. market must register with the FDA. 

  • Timing: New facilities must register within 5 days of beginning operations.
  • Renewal: Registration must be renewed annually between October 1 and December 31.
  • Verification: Registration can be verified at  https://www.accessdata.fda.gov/scripts/cder/drls/

2. Product Listing

  • Registered facilities are required to list all drug products they market. Each product is assigned to a unique National Drug Code (NDC). 
  • Compliance: Most antacids marketed under OTC Monograph M001.11, which sets standard rules for safety.

3. Label compliance

  • Labels must include “Drug facts’ with indications, warnings, direction of use and contact information to report adverse events.

Liberty Management Group , as a leading FDA consultant will provide assistance  with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

DRUG LABELING

Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading

All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.

All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.

Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.

When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.

Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us