Question

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topic: nonprescription drug permits

Identify the sponsor(s), who introduced the legislation and their efforts to advance the legislation.

Identify and discuss the stakeholders, who are/will be affected by the legislation and their role in the legislation’s process.

Answer 1

NONPRESCRIPTION DRUG PERMITS:

Nonprescription drug means drugs which can sold directly with out prescription from physician or health care professional. these are also known as OTC drugs ( over - the - counter drugs). these drugs are regulated by agencies that enforce safety and standards ,in US Food and Drug Administration is an example of regulatory agencies.

   any non prescription drug mat be manufactured and sold with out an individual product license. the NDA process is the approval of a new drug for sale and marketing in the u.s as specified in the Federal Food Drug and cosmetic Act 1938.

the goal s of OTC NDA process:

1. the is drug is safe and effective in its current state.
2. the benefits of the drug out weigh the risk
3. the methods used in manufacturing are adequate to preserve the drug identify strength, quality, and purity.
4. the drug labelling is adequate.

the purpose of non prescriptive drugs regulation has to

1.to ensure quality and safety

2. to improve public health

3.to encourage the competitiveness of the nonprescription industry.

the Oregon board of pharmacy has the responsibility for implementing and regulating chapters 475(Oregon uniform controlled substances act) and 689(Oregon pharmacy act) of the Oregon revised acts

the prescribing legislation in relation to non prescription medicines ,there are three supply categories are outlined, prescription only, general sale list, pharmacy medications

changes legislation towards increased availability of medicines that do not required prescription.

role of legislation process: it improve quality,maintain standars ,regulation of use of non prescription drugs .

due to non prescription drug permits will effects the medicine distributer and sellers

due to maintain standards of quality norms it will take more time to approve .