Labeling of Drugs Under FDA
It is always mandatory to have medicines, or even if you recommend them to someone else, they should be well prescribed, labeled. Having products under proper labeling is not only safe but a sage thing to do. It saves you from further complications if any arises.
What is FDA Drug labeling?
FDA Drug Labeling is nothing but correct Labeling of products, be it medicines or something else. The labeling includes all information about the drugs in use, including biological products approved by the United States. The labeling consists of the product information, its regulatory history, prescribing information, and labeling as per the patient’s need. It also includes various reviews given by the FDA staff regarding safety and precautions.
What are the few pieces of information that are most important to look for on prescription labeling?
FDA Drug Labeling or Prescription Labeling as it is also called gives you a total insight into the product you are buying. In simple terms, It makes you aware of the product or medicine you are interested in buying.
When buying a product, be it prescribed medicine or anything for personal use, one should always look for:
1. Name and address of the pharmacy.
2. the Serial number of the prescription.
3. Date of the prescription.
4. Name of the prescriber.
5. Name of the patient.
6. Name and actual strength of the drug to be used.
7. The generic name of the drug.
8. Directions for use.
9. Statements using Cautions.
10. Mentioning of the Dispensing Pharmacist at least with the first initials or the surname.
11. It should be mentioned as a statutory warning if the prescribed drug contains any kind of alcohol, tranquilizer, or sedative. Sometimes it might be harmful on the consumer’s part or have an adverse effect.
12. A discard date should be mentioned if the drug is dispensed in any container other than the manufacturer’s original container.
13. If the prescription is dispensed in the manufacturer’s original container, then there is no requirement to label the product’s expiration date and storage statement dispensed in the manufacturer’s original container.
What are Prescription drug labeling resources?
When using an OTC medicine, reading the labeling is essential. The label gives you complete information regarding the medicine and its do’s and don’ts. The product should have “Drug Facts” written in a simpler language for the customers to read and understand.
Information about usage, directions, and warnings are written on the different parts of the product covers. It is very important to know the details before intaking it for those who might be allergic to any ingredient in the product. The labels, warnings, patents should be written in simple language.
Why does the FDA consider labeling?
FDA Drug Labeling is the
written, printed, or graphic writings present on a prescribed drug. It may be like an article on the containers or wrappers or like an extra packaging on the container. It all depends on the situation, including packaging, inserting products, its Websites, and other promotional materials.
Functions of drug labeling?
FDA Drug labeling plays a very important role in the identification of active ingredients of a drug, but also it serves as a guide to the patients. This not only ensures safety but also gives information on the administration of the medicines. Drug labeling gives the patients a right to know so that there is the right use of the medicine in concern. For healthcare professionals, it gives an insight into the essential information required in prescription and dispensing.
Conclusion: Labeling of products, especially on drugs, is mandatory. It is responsible for the safety of the consumers and ensures the efficiency of the product. FDA Product Labeling not only issues warnings and usage information but educates about the drug/product in use.
