Final answer:
The Poison Prevention Packaging Act of 1970 allows prescribers to request a prescription in non-child-resistant packaging, primarily for the convenience of elderly or disabled patients. This is part of the FDA's role in regulating medication safety and efficacy, balancing the protection of the public with the potential delays and costs in drug development.
Step-by-step explanation:
The federal statute that allows prescribers to request that a single prescription order for an individual patient be dispensed in non-child-resistant packaging is known as the Poison Prevention Packaging Act (PPPA) of 1970. This act was put in place to protect children from accidental poisoning by ensuring that most medications are distributed in child-resistant containers. However, the law does permit exceptions upon specific request from the prescriber or the patient for convenience or due to difficulty opening child-resistant packaging, which is often the case for elderly patients or those with disabilities.
Pharmacies must comply with this regulation, but they are also responsible for ensuring that patients requesting non-child-resistant packaging are aware of the risks. The PPPA is an example of how the Food and Drug Administration (FDA) enacts regulations to protect public health, including the safety and efficacy of medications. The introduction of the Medicare prescription drug benefit was another step toward assisting vulnerable populations such as the elderly and disabled in managing the costs of their medications.
The conversation about drug regulation is nuanced, acknowledging both those who benefit from the protections against unsafe medications and those who may suffer due to the lengthy and costly process of bringing a new drug to market. These regulations can have the unintended consequence of delaying access to potentially beneficial drugs and can add to the financial burden of drug development, which might be reflected in the final cost of prescription drugs.