What is a FDA monograph?
An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market …
What is monograph medication used for?
A drug monograph is a predetermined checklist covering active ingredients, doses, formulations and product labeling that the agency considers generally safe and effective for self use.
What is USP monograph?
An Overview of USP Monographs. Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.
What does USP mean on medicine?
United States Pharmacopeia
United States Pharmacopeia: Abbreviated USP. A publication, established in 1820, that contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for drug substances, dosage forms, and other therapeutic products, including nutritionals and dietary supplements.
What is the USP standard?
A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.
Which is better doxycycline or azithromycin?
The beneficial effect continued until 2 months after treatment. In the azithromycin group three patients had diarrohea, while photosensitivity was seen in two patients using doxycycline. This study indicates that azithromycin is at least as effective as doxycycline in the treatment of acne.
What are the characteristics of a USP monograph?
A monograph is a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA). Some of these attributes include: Identity – Tests to identify that a particular substance is the medicine that it claims to be.
Are there USP monographs for products not approved by FDA?
USP also develops monographs for therapeutic products not approved by FDA, e.g., pre-1938 drugs, dietary supplements, and compounded preparations. Although submission of information needed to develop a monograph by the Council of Experts is voluntary, compliance with a USP–NF monograph, if available, is mandatory in the following respects:
How are monographs used in the United States?
Monographs are utilized to help ensure patient safety. USP’s publicly available monographs are used by regulators, public health authorities, and others to confirm that the medicines provided to patients meet quality expectations for safety and effectiveness. Monographs help secure the global drug supply chain
What are the USP standards for Biologics and drugs?
The following graphic illustrates the applicability of USP standards to drugs and biologics in the United States.