Why is 21 CFR important?
The purpose of these guidelines is to ensure that all new products are safe and effective for use. In this chapter, medicinal drug manufacturers have access to all the required documentation needed to streamline the pre-approval process and avoid regulatory audit.
What is the difference between SPC and PIL?
Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal product’s properties and the conditions attached to its use.
What is full form of ICH?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
What is PL code medical?
A Product Licence Number (or PL code for short) is a unique identifier on the packaging of medicines, used to uniquely identify the product.
What is PIL and SMPC?
Medicines. Patient information leaflets (PIL) and summaries of product characteristics (SPC) for medicines for human use.
What is a drug PI?
One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drug’s label, also known as the prescribing information or the package insert (PI).
What is GMP and GLP?
“GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). These regulations are imposed for ensuring the safety and integrity of drugs.
What is unlicensed medication?
Unlicensed medicines Off-label use means that the medicine isn’t licensed for treatment of your condition. But the medicine will have a licence to treat another condition and will have undergone clinical trials for this.
What does authorized dispenser mean under § 208?
§ 208.3 Definitions. For the purposes of this part, the following definitions shall apply: ( a) Authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice.
How do I search for information within part 208?
To search for information within Part 208, use your browser’s built-in “find on page” functionality. You can access this using ctrl + F on Windows or ⌘ + F on macOS. These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR.
What is the Code of Federal Regulations (CFR)?
The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR.