# Law No. 8926 of August 9, 1994

> Brazilian law

**Wikidata**: [Q105647525](https://www.wikidata.org/wiki/Q105647525)  
**Source**: https://4ort.xyz/entity/law-no-8926-of-august-9-1994

## Summary
Law No. 8926 of August 9, 1994 is a Brazilian statute that makes it mandatory to include warnings and recommendations about medication use for people over 65 years old on pharmaceutical labels.

## Key Facts
- **Official Title**: Lei nº 8926, de 9 de agosto de 1994
- **Law Digest**: Requires inclusion of warnings and recommendations for medication use by individuals over 65 years old on pharmaceutical labels
- **Country**: Brazil
- **Approval Authority**: Presidency of the Federative Republic of Brazil
- **Promulgator**: Itamar Franco (President at the time)
- **Publication Date**: 1994-08-09
- **Place of Publication**: Brasília
- **Language**: Brazilian Portuguese
- **LXML ID**: urn:lex:br:federal:lei:1994-08-09;8926
- **Legal Citation**: Lei nº 8926/1994
- **Jurisdiction**: Applies to Brazil
- **Instance Type**: Statute
- **Main Subjects**: Determination, usage, addition, obligation
- **Available URL**: https://www.planalto.gov.br/ccivil_03/leis/1989_1994/l8926.htm
- **Wikimedia Focus**: WikiProject Brazilian Laws

## FAQs
**What does Law No. 8926 require pharmaceutical manufacturers to do?**
The law mandates that pharmaceutical labels must include specific warnings and recommendations regarding the use of medications by individuals aged 65 and older.

**Who approved this law and when?**
President Itamar Franco promulgated Law No. 8926 on August 9, 1994, making it officially effective.

**What is the primary purpose of this legislation?**
The legislation aims to enhance patient safety by ensuring elderly patients receive appropriate information about medication usage, particularly considering age-related health considerations.

**Where can the full text of this law be found?**
The complete text is available at the official Brazilian government website: https://www.planalto.gov.br/ccivil_03/leis/1989_1994/l8926.htm

**What is the legal citation format for this law?**
The standard citation format is Lei nº 8926/1994.

## Why It Matters
Law No. 8926 represents an important public health initiative in Brazil, addressing the specific needs of an aging population. By mandating age-specific warnings on medication labels, the law aims to reduce medication-related adverse effects among elderly patients who may have different physiological responses to drugs compared to younger individuals. This legislation reflects broader trends in geriatric medicine and pharmacology, where age-related considerations are increasingly recognized as critical factors in drug safety and efficacy. The law helps bridge the gap between standard medication instructions and the unique health needs of older adults, potentially preventing adverse drug events and improving treatment outcomes for this vulnerable demographic.

## Notable For
- **Specific Public Health Focus**: The law specifically targets elderly patients by requiring age-appropriate warnings on medication labels, addressing a particular demographic need
- **Age-Specific Regulation**: It represents one of the earliest federal regulations in Brazil mandating age-related considerations in pharmaceutical labeling
- **Implementation in Brazilian Law System**: The law demonstrates the Brazilian legal system's approach to integrating geriatric considerations into standard drug regulations
- **Public Health Initiative**: Serves as an example of proactive legislation aimed at improving medication safety for vulnerable populations
- **Official Government Publication**: The law is published on the official Brazilian government website, ensuring public access to the legal text

## Body
### Definition and Legal Classification
Law No. 8926, enacted on August 9, 1994, is a federal statute in Brazil that falls under the broader category of "statutes" as defined by legal terminology. The legislation is classified as an instance of a statute, which is a formal written document that creates law, encompassing acts, executive orders, and by-laws. This law specifically addresses pharmaceutical labeling requirements and is categorized as a subclass of written work, document, and rule within legal knowledge systems.

### Purpose and Content
The primary objective of Law No. 8926 is to enhance medication safety for elderly patients by mandating specific information on pharmaceutical labels. The law requires pharmaceutical manufacturers to include warnings and recommendations regarding the use of medications by individuals over 65 years old. This requirement is designed to address the physiological changes that occur with aging, which can affect drug metabolism, absorption, and response.

### Implementation and Enforcement
The law was promulgated by President Itamar Franco on August 9, 1994, and published in the official government gazette. The implementation involves pharmaceutical companies modifying their labeling protocols to incorporate age-specific information. The law applies throughout Brazil and is enforced by regulatory authorities responsible for pharmaceutical oversight.

### Jurisdiction and Scope
The legislation applies exclusively to Brazil and covers all pharmaceutical products marketed within the country. The law is written in Brazilian Portuguese and is available for public access through the official government website. The legal citation format is Lei nº 8926/1994, which follows standard Brazilian legal citation conventions.

### Technical Specifications
The law's implementation requires pharmaceutical labels to contain specific information about medication use for elderly patients. This includes warnings about potential side effects, dosage adjustments, and special considerations for individuals with age-related health conditions. The requirement applies to all prescription and over-the-counter medications marketed in Brazil.

### Related Legal Framework
Law No. 8926 operates within Brazil's broader legal system that includes other health-related statutes and regulations. It complements the country's constitution and other federal laws concerning public health, pharmaceutical regulation, and consumer protection. The law is maintained and updated through the standard legislative processes established by the Brazilian government.

### Historical Context
The passage of Law No. 8926 occurred during a period when Brazil was implementing various health and social welfare reforms. The legislation reflects growing recognition of the needs of an aging population and the importance of age-appropriate medical information. It represents one of many federal laws enacted in the 1990s addressing public health concerns and consumer protection issues.

### International Comparisons
While similar age-related labeling requirements exist in other countries, Law No. 8926 is notable for its specific focus on elderly patients and its comprehensive approach to medication labeling. The law demonstrates Brazil's commitment to addressing geriatric health concerns through regulatory measures, aligning with international best practices in pharmaceutical regulation and patient safety.

### Impact and Effectiveness
The law has contributed to improved medication safety for elderly patients in Brazil by ensuring that age-related considerations are incorporated into standard drug labeling. This has helped healthcare providers and patients make more informed decisions about medication use, potentially reducing adverse drug events and improving treatment outcomes for older adults. The legislation serves as a model for other countries considering similar age-specific labeling requirements.

## References

1. [Source](https://www.lexml.gov.br/urn/urn:lex:br:federal:lei:1994-08-09;8926)
2. [Source](https://legislacao.presidencia.gov.br/atos?tipo=LEI&numero=8926&ano=1994&data=09/08/1994&ato=900MzaE50dJpWT0fc)
3. LexML Brasil