What is included in a drug monograph?

What is included in a drug monograph?

A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain.

How do you find drug monographs?

Prescription and Non-prescription Monographs

1. RxList. The Internet Drug Index – part of the WebMD network.
2. Drugs.com. Data sources include the Physicians’ Desk Reference (PDR), Cerner Multum, Thomson Reuters Micromedex and Wolters Kluwer Health.
3. Medscape Drugs & Diseases. Free registration required – from WebMD.
4. RxFiles.

What are the 4 categories of medicines?

The 4 Categories of Medication

• General Sales List (GSL) GSLs are a type of medicine that have few legal restrictions.
• Pharmacy Medicines. Pharmacy Medicines are only available to purchase behind the counter at a pharmacy.
• Prescription Only Medicines.
• Controlled Drugs.

What is the OTC monograph system?

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 NF monograph?

USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.

What is a monograph example?

An example of a monograph is a book on how the human body uses Vitamin D. A scholarly book or a treatise on a single subject or a group of related subjects, usually written by one person. To write a monograph on (a subject).

What are the 6 classification of drugs?

When considering only their chemical makeup, there are six main classifications of drugs: alcohol, opioids, benzodiazepines, cannabinoids, barbiturates, and hallucinogens. Out of all the thousands of drugs that are out there, both prescription and illegal, each one can be categorized under one of these six headings.

What is a monograph Pharmaceutical?

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.

Is hand sanitizer an OTC monograph drug?

While many consumers might not think of hand sanitizers as drugs, they are in fact regulated as OTC drugs by FDA and have been the subject of recent rulemaking by the agency.

What is Pharmacopeial monograph?

A pharmacopeial monograph provides detailed parameters that are used to determine whether a medicine meets key quality attributes and can be marketed legally in any given country.

What are the names of the drug monographs?

Azacitidine. Azelaic Acid (FINACEA) Foam Monograph. Azilsartan, Drug Monograph. Bedaquiline Drug Monograph; restricted to ID or local designee. Belatacpet (Nulojix) Drug Monograph. Belimumab Drug Monograph. Bendamustine Monograph.

What are the advantages of the AHFS Drug Information monographs?

AHFS Drug Information Monographs Advantages: Written for the professional, the AHFS DI monographs contain over 1,300 in-depth clinical drug descriptions on over 40,000 represented medications and virtually every single drug entity available in the United States.

Where can I find FDA prescribing information for professionals?

FDA Prescribing Information for Professionals – Drugs.com FDA Professional Drug Information The Professional Drug Information database is a repository of drug information sourced directly from the FDA. It includes detailed notes on the clinical pharmacology of a wide variety of drugs.

How many drug descriptions are in the AHFS di?

Written for the professional, the AHFS DI monographs contain over 1,300 in-depth clinical drug descriptions on over 40,000 represented medications and virtually every single drug entity available in the United States.