What are monograph drugs?

What are monograph drugs?

Drug monograph means the informational documents that are provided every time a new medication is ordered for a patient that contains specific drug-related uses, warnings, side effects and other information, depending on the medication dispensed.

What are OTC monograph drugs?

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 …

Where can I find a drug monograph?

Prescription and Non-prescription Monographs

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

How do I find FDA monograph?

For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labeling. Many of these monographs are found in section 300 of the Code of Federal Regulations.

What is USP monograph?

USP Monographs for Bulk Drug Substances and Other Ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. These monographs appear in the USP–NF.

What is an ingredient monograph?

Single Ingredient Monographs A monograph is a written description of particular elements on an identified topic. Single ingredient monographs apply to formulations containing only one medicinal ingredient.

What is difference between Pharmacopoeia and monograph?

In a broader sense, pharmacopoeia is a reference work for pharmaceutical drug specifications. Descriptions of preparations are called monographs. A monograph is a paper on a single topic.

What is OTC in pharma?

‘Over-the-Counter (OTC) Medicines’ means drugs which are legally allowed to be sold by pharmacists without need for a prescription. The term does not have a legal definition in India. Technically, drugs are OTC unless they are specifically stated as prescription only drugs.

What means by monograph?

Definition of monograph (Entry 1 of 2) : a learned treatise on a small area of learning his concise monograph on The Authorship of Shakespeare’s Plays— Brian Vickers also : a written account of a single thing wrote a monograph on the art of origami. monograph. verb. monographed; monographing; monographs.

What is monograph in herbal drug technology?

Specific Tests Regarding foreign organic matter, HMC monographs are specific in defining the article by stating the plant part(s) (e.g., leaves, flowers, etc.) or plant product(s) (e.g., resins, gums, etc.) used.

How do you write a drug monograph?

Each written monograph must be typed (using a font size of 11 or higher) and must include the drug’s name (generic and at least one U.S. trade name), your name, and the drug’s chemical structure at the top of the monograph (see example in the next chapter).

What is Formulary monograph?

Formulary drug monographs prepared by the Drug Information Service of the PBM include a critical analysis and summary of disease-oriented and patient-oriented clinical outcomes, effectiveness, and humanistic data.

What are OTC antibiotics?

Topical over-the-counter antibiotics include:

  • Neosporin (bacitracin/neomycin/polymyxin B)
  • Polysporin (bacitracin/polymyxin B)
  • Neosporin Plus (neomycin/polymyxin B/pramoxine)
  • Proactiv/Clearskin (Benzoyl peroxide)

What are examples of monograph?

The definition of a monograph is a long, detailed scholarly piece of writing on a specific subject. An example of a monograph is a book on how the human body uses Vitamin D. To write a monograph on. (historical) A treatise on a single genus, species, etc.