The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.
Rubbing alcohol is either an isopropyl alcohol or an ethanol-based liquid, with isopropyl alcohol products being the most widely available. The comparable British Pharmacopoeia (BP) is surgical spirit. Rubbing alcohol is denatured and undrinkable even if it is ethanol-based, due to the bitterants added.
A pharmacopoeia, pharmacopeia, or pharmacopoea, in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
Sodium benzoate also known as benzoate of soda is the sodium salt of benzoic acid, widely used as a food preservative (with an E number of E211) and a pickling agent. It appears as a white crystalline chemical with the formula C6H5COONa.
The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.
Emulsifying wax is a cosmetic emulsifying ingredient. The ingredient name is often followed by the initials NF, indicating that it conforms to the specifications of the National Formulary.
Pill-splitting refers to the practice of splitting a tablet or pill to provide a lower dose of the active ingredient, or to obtain multiple smaller doses, either to reduce cost or because the pills available provide a larger dose than required. Many pills that are suitable for splitting come pre-scored so that they may easily be halved.
The European Pharmacopoeia is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
In the field of pharmacy, compounding is preparation of a custom medication to fit a unique need of a patient that cannot be met with commercially available products. This may be done for medical reasons, such as administration in a different format, to avoid a non-active ingredient the patient is allergic to, or to provide an exact dose that isn't commercially available. Patient-specific compounding according to a prescriber's specifications is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity to individual optimality to even preference.
Chinese patent medicine are herbal medicines in Traditional Chinese medicine, modernized into a ready-to-use form such as tablets, oral solutions or dry suspensions, as opposed to herbs that require cooking.
The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets. (ii) Equivalence decisions: during generic product development, and also when implementing post-approval process or formulation changes, similarity of in vitro dissolution profiles between the reference product and its generic or modified version are one of the key requirements for regulatory approval decisions. (iii) Product compliance and release decisions: during routine manufacturing, dissolution outcomes are very often one of the criteria used to make product release decisions.
The Pharmacopoeia of the People's Republic of China (PPRC) or the Chinese Pharmacopoeia (ChP), compiled by the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China, is an official compendium of drugs, covering Traditional Chinese and western medicines, which includes information on the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug.
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication. Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. Under the INN system, generic names for drugs are constructed out of affixes and stems that classify the drugs into useful categories while keeping related names distinguishable. A marketed drug might also have a company code or compound code.
The Food Chemicals Codex (FCC) is a collection of internationally recognized standards for the purity and identity of food ingredients.
In chemistry, chemical purity is the measurement of the amount of impurities found in a sample. Several grades of purity are used by the scientific, pharmaceutical, and industrial communities. Some of the commonly used grades of purity include:
