Labeling professional

Hair products are normally cosmetics and are thus subject to aU. laws and regulations that control the labeling and claims of aU. cosmetic products. There are, however, several significant variations to this premise, ie, hair colorants, professional use only products, and products that make dmg claims. 

The Fair Packaging and Labeling Act does not apply to products used in professional estabHshments. Specifically, this means that these products are not required to have an identity statement or a Hst of ingredients. This exception, however, is limited only to those products actually intended for professional use. Products sold by the professional estabHshments to their customers for personal use are considered retail products and must be fully labeled as such. 

Although these professional-use-only products do not require ingredient labeling, the cosmetics industry has developed a program to voluntarily Hst the components of professional products. However, under this voluntary program, the ingredients are Hsted in alphabetical order rather than descending order. This has been done to make it easier for the professional hairdresser to locate a specific compound that may be of interest. 

The Fair Packaging and Labeling Act, which uses the same definitions for dmgs and cosmetics as the Food, Dmg and Cosmetic Act, only has jurisdiction over retail products sold to the consumer for use at home. This condition exempts free samples and professional use products not sold to a consumer for personal use. 

A statement as to whether the drug is (or is not) limited in its labeling and by this application to use under the professional supervision of a practitioner licensed by law to administer it... 

Physicians are the prime recipients of this information, and their treatment of individual patients should be guided by it. (Guided is the correct word. The FDA cannot regulate individual physician practice. If information in the published literature supports use of a drug for conditions not described in the approved labeling, a physician has the right to prescribe for these off-label uses. One hopes there is evidence to support this indeed, medical professional societies often develop position papers when evidence becomes available to support such uses.)... 

Subpart G, Labeling Control of Excess Products. If a quantity of a compoimded drug product is prepared in excess of that to be initially dispensed in accordance with Subpart A, the excess product shall be labeled or documented with the complete list of ingredients (components), the preparation date, and the assigned expiration date based upon professional judgment, appropriate testing, or published data. 

A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including prescribing order communication product labeling, packaging, and nomenclature compounding dispensing distribution administration education monitoring and use. 

Serious medication errors, including some leading to death, have resulted from the interpretation of the Cerebyx product labeling. The terminology on the label, which previously indicated the concentration as being 50 mg of phenytoin equivalents (PE) per milliliter, was misinterpreted as the total number of PEs per vial. Furthermore, health professionals were reportedly confused by the expression phenytoin equivalents, a prodrug concept introduced for this product. As a result, massive fosphenytoin overdoses were mistakenly administered. 

The Council encourages collaboration among industry, regulators, standards-setters, health care professionals, and patients to facilitate design of packaging and labeling to help minimize errors. 

TABLE 5 Recommendations to Health Care Professionals to Reduce Errors Due to Labeling and Packaging of Drug Products and Related Devices (Adopted March 30, 1998)... 

In addition, the Council makes the following recommendations to health care professionals to reduce errors due to labeling and packaging of drug products and related devices ... 

The Council encourages health care professionals to use only properly labeled and stored drug products and to read labels carefully (at least three times—before, during, and after use). 

It should be noted that the Medicines and Healthcare products Regulatory Agency s guidance notes on advertising and promotion state that each page of an advertisement for a prescription only medicine should be clearly labelled as intended for health professionals. 

For health professionals in consultations with patients complaining of diarrhea, it is pertinent to ask "Is it oily " and "Have you consumed fish " If answers are confirmative, the case should be reported to food inspection agencies. To follow up on the alert, food inspection agencies should collect the expelled oil sample, a residual sample of the cooked fish (if available), and any uncooked fish from the same source to check for wax esters. If wax esters are detected, DNA analysis should be applied, if possible, to identify the source species. Concurrently during the inspection process, food safety agencies should trace back to the supply source of the fish to see if proper labels were in place. If not,... 

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