Formulary monograph

Table 12.3 Elements Contained in a Typical Formulary Monograph...

Polyethylene glycols are approved for use in food, pharmaceutical, and cosmetic applications. Food additive approvals for polyethylene glycols are covered in Title 21 of the Code of Federal Regulations. The reader should check with the supplier for details on using polyethylene glycols in food applications. Pharmaceutical uses are covered in the requirements listed in the National Formulary Monographs (American Pharmaceutical Association, Washington, D.C.). 

In the United States, oxygen USP must meet the specifications listed in the current United States Pharmacopoeia/National Formulary monograph for oxygen and comply with the Federal Food, Drug, and Cosmetic Act and associated regulations as administered by FDA [2]. 

The first official injection (morphine) appeared in the British Pharmacopoeia (BP) of 1867. It was not until 1898 when cocaine was added to the BP that sterilization was attempted. In this country, the first official injections may be found in the National Formulary (NF), published in 1926. Monographs were included for seven sterile glass-sealed ampoules. The NF and the United States Pharmacopeia (USP) published chapters on sterilization as early as 1916, but no monographs for ampoules appeared in USP until 1942. The current USP contains monographs for over 500 injectable products [1]. 

The committee classified products subject to monographs in the British Pharmacopoeia (BP), British Pharmaceutical Codex (BPC) and the British National Formulary (BNF) as Category M-Products. Acceptable products other than monograph preparations were Category A-Products. All other products were Category B-Products, these were considered less effective or more toxic than those in Categories M or A or their efficacy was regarded as unproven. 

The BNF Joint Formulary Committee as of May 2005 will publish a Paediatric version annually. It will comprise monographs on safe and effective medicines for use in children, even if usage in children is not included in the summary of product characteristics (SPC). 

The addition of the National Formulary section to the pharmacopeia, followed more recently by the section of Nutritional Supplements, has resulted in a considerable increase in the numbers of substances described by an official monograph. These are mainly excipients and diluents for the NF and standards for the popular Nutritional Supplements (including my personal favorite, Chocolate). 

The major obstacle to the success of coprocessed excipients in the marketplace is their noninclusion in official monographs. The mixture of excipients was presented as a topic to the National Formulary and was assigned a priority on the basis of its use in marketed dosage forms in which processing provided added functional value to the excipient mixture (35). 

Committee of Revision. Monograph 701, Disintegration Monograph 711, Dissolution. In United States Pharmacopeia XXIV/ National Formulary XIX United States Pharmacopeial Convention, Inc. Rockville, Md, 2000 1941-1943. 

Although great advances have been made in the techniques and mechanics of ampul production, Limousin s simple rules capture the basic underlying principles. In the United States, ampuls, or hermetically sealed containers which are filled with a medicinal liquid in a sterile condition, intended for parenteral use, became official in the National Formulary V (1926) that same year, the United States Pharmacopeia X included a chapter on sterilization but no monograph for individual ampuls. Iodine Ampuls, N.F., containing Iodine Tincture, United States Pharmacopeia, in sealed containers, intended to be broken and the liquid applied topically for the emergency disinfection of cuts or wounds, remained official through the National Formulary XIII (1970). The French term... 

The USP was established in 1820 to provide public standards for therapeutic products, names, and recipes for their preparation. In 1880, the USP shifted from being simply a recipe book to one that contained medication standards for purity, quality, and potency. The USP standard monographs are published in the USP and National Formulary (NF), the latter containing pharmacopeial information for thousands of drugs and excipients. ... 

The BP has provided authoritative standards for the quality of many substances, preparations and articles used in medicine and pharmacy for over 130 years, the current edition being the British Pharmacopoeia 1998. The BP incorporates most of the monographs of the European Pharmacopoeia, as well as additional monographs for certain formulary products. 

The proposed United States Pharmacopoeia National Formulary (USP-NF) monograph for hypericum requires that products contain a minimum of 0.04% of hypericins (95). 

Saw palmetto is considered a dietary supplement by the Food and Drug Administration (3). Saw palmetto was previously included in the National Formulary (NF) and the United States Pharmacopeia, but was deleted in 1950 and 1916, respectively. Saw palmetto was deleted because no active ingredient could be found to account for its use (2). Saw palmetto was again included in the NF as an official monograph in 1998 (4). 

Several years after the successful launch of a new product, it is typical for North American pharmaceutical firms to become involved in the United States Pharmacopeia-National Formulary (USP-NF) revision process to allow inclusion of their API and formulations in the USP-NF. The USP-NF and their supplements are a compilation of monographs prepared under the authority of the Pharmacopeial Convention. The purpose of the USP-NF and supplements is to provide authoritative standards and specifications for materials and substances and their preparations that are used in health care or for the improvement or maintenance of health.16 The revision process— as outlined in the USP-NF—begins with inquiries, comments and suggestions for revision in the USP-NF text mailed directly to the USP.17 Participation in this process ensures consideration of the innovator s methods, specifications, and reference standards for inclusion in the USP-NF. Approval for inclusion in the USP-NF is gained after consideration by an Expert Committee of the USP Council of Experts. If the Expert Committee so recommends, the proposed revision is published in the Pharmacopeial Forum (PF) for review and comments by interested readers of the PF. The comments and data submitted by interested readers are reviewed and addressed, and the Expert Committee then decides whether to recommend to the USP Council of Experts that the proposed revision should be adopted in the USP-NF. 

It is important that pharmacists are aware of the contents of their respective parts of the Drug Tariff. The Drug Tariff is updated on a monthly basis and so is the primary reference source for information on drugs and other substances not to be prescribed on an NHS prescription form. However, the British National Formulary does also indicate if an item is not to be prescribed on the NHS by annotating the monograph in the text with a crossed-out NHS (see Figure 2.4). 

Figure 2.4 This entry next to an item s monograph in the British National Formulary indicates that it is not to be prescribed on an NHS prescription form.

British National Formulary does also indicate whether an item would need to be endorsed SLS before being supplied by annotating the monograph in the text SLS. However, pharmacists and pharmacy technicians should always remember that the British National Formulary is only updated once every six months and so is usually less up-to-date than the respective Drug Tariff. 

The AHFS Framework enables developers to easily embed drug content into pharmacy and clinical information systems. It can be used to rapidly integrate two respected drug knowledge bases the American Hospital Formulary Service (AHFS) Drug Information monographs, and First DataBank s NDDF Plus. Combined, they allow healthcare professionals to have seamless access to comprehensive drug information, within their usual work-flow systems. 

Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers Monograph. USP 29-NF 24 The United States Pharmacopoeia and The National Formulary The Official Compendia of Standards. Rockville, MD The United States Pharmacopeial Convention, Inc, 2006 2617-2636. 

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