1. Food and Drug Administration (FDA)
  2. What impact does this Agency have on compliance with regulatory standards

The Agency ensures the safety, efficacy, and security of most foods, cosmetics, veterinary drugs, tobacco products, color additives, non-prescription and prescription drugs, medical devices, dietary supplements, and products that emit radiation. The Agency also ensures compliance with the Federal Food, Drugs, and Cosmetic Act of 1938, promoting public health by preventing fraudulent activity concerning food, drugs, and another array of general health products (Armstrong &Staman, 2018). The Agency does examinations of products to establish whether they are fit for animal or human consumption, receives any complaints regarding food and drugs and launches and does investigations; the Agency lays out the procedure for dissemination and distribution of medicines to the public, does pre-market reviews for some products before they are distributed into the market like medical devices. The FDA Agency also does post-market examinations to ensure the products continue to meet the required standards. The FDA also monitors imports into the U.S to ensure that they meet the standards set in the U.S.

  • What impact does this Agency have on standards of care?

The Agency ensures distributors, manufacturers, packers, processors, and those who handle drugs and food maintain a high standard of care. For example, manufacturers, packers, and distributors of drugs are prohibited from misbranding and adulterating drugs. A drug is misbranded if its label lacks the place of business of the manufacturer, the name of the manufacturer, manufacturing date, serial number, and expiration date. The Agency also raises the standard of care by requiring manufacturers of drugs to state how the drug is to be administered, the side effects of the drugs, the required age of the partaker, how the drug is to be stored, and the effects of overdosing.  The Agency also ensures food companies and hotels handle food in proper sanitary conditions.  The Agency inspects food outlets, hotels, and restaurants to ensure that they comply with hygienic foods’ required standards. The Agency also maintains a high standard of care by requiring medical devices to pass through them for pre-approval before being distributed to the public.

  • What impact does this Agency have on potential liabilities for a healthcare entity?

The Agency conducts investigations in case of customer complaints and ensures compliance with the Federal Food, Drug, and Cosmetic Act. FDA does not have independent litigating authority; hence it works together with the Department of Justice (DOJ) to address non-compliance. The Department of Justice (DOJ), together with the FDA, may enforce the Federal Food, Drug, and Cosmetic Act through civil penalty proceedings, criminal prosecutions, injunctions, and seizures (Horton, 1998).  Independently, FDA may issue several administrative tools to avoid civil and criminal misconduct such as issuing warnings to drug stores and manufacturers who do not comply with the set rules and standards, issuing untitled letters, debarments, recalls in case of distribution of medicine that is harmful to the consumer or does not comply with the set standards and civil money penalties.

  • Occupational Safety and Health Administration (OSHA)
  • What impact does OSHA have on compliance with regulatory standards

The Occupational Safety and Health Administration Regulatory Agency ensures safety and healthy working conditions for all public and private sectors. The OSHA Agency sets and enforces standards to be applied in the workplace. OSHA enforces its standards and regulations by conducting investigations in workplaces based on fatality, imminent danger situations, or workplace complaints.

OSHA requires those workers working in relatively and extremely dangerous situations to be provided with protective equipment and limit their exposure to hazardous chemicals and gases. The Agency also mandates workplaces to install safety rails and special pathways for people with disabilities. In preparation for any fire outbreak, the Agency advises workplaces to ensure they have emergency exits and fire extinguishers. The Agency also conducts employee training and educational programs on how to interpret hazardous material, how to act in case of an emergency, how to create a safe working condition, and how to handle accidents.

  • What impact does OSHA have on standards of care?

The Agency improves the standard of care by encouraging industries that deal with chemicals to limit chemical exposure access. Also, it requires employees working in hazardous environments to have access to security and safety information detailing the effect of overexposure and impact of chemicals spilling on the workers. The Agency also requires those employees working in hazardous environments to have access to protective equipment and gear. The Agency mandates workplaces to prevent overexposing their workers to confined places, put up guardrails beside stairs to prevent injury.

The Agency also encourages employers’ standard of care by requiring employers to install emergency equipment in the workplace such as fire extinguishers and fire and emergency exits. The Agency also provides education and training on handling injuries, first aid practices, ways of ensuring safety in the workplace, standard of care required in a workplace, and how to handle emergencies.

  • What impact does OSHA have on the potential liabilities of a healthcare entity?

Since OSHA inspects workplaces to ensure their compliance with safety in the workplace, OSHA can take action against health entity that overexpose their employees to hazardous chemicals, OSHA can issue warnings to employers in hospitals who do not provide protective equipment and gear to its employees who work in dangerous situations and circumstances that have a high risk to injury or exposure to harm.  OSHA can also mandate hospitals, dispensaries, and pharmacies that like emergency equipment like fire extinguishers and fire exits to install such.

In case of complaints from the workplace, OSHA can inspect the work to evaluate the complaints and confirm their compliance with the OSHA rules and regulations. OSHA may review the decisions of the employer if they are deemed unfair and unjust against the employee.

REFERENCES

Armstrong &Staman (2018), Enforcement of the Food, Drug and Cosmetic Act: Select Legal Issues, Congressional Research Service Retrieved on https://fas.org/sgp/crs/misc/R43609.pdf   

Bazan A.(2019), Impact of Occupational Health and Safety Regulations on the Employee’s Decision to Take up Employment

Throckmorton D. (2017), The Public Health Role of Drug Regulation in the US, FDA, Retrieved on November 10, 2020

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