Pharmaceutical Manufacturing Legislation : Regulated Medicinal Products Essay

There are many checkpoints to reduce the risk of these medications reaching patients Boards of Pharmacy need to continue to filter out the bad actors (distributers, pharmacists, and non-pharmacist purchasing agents). But the pharmacist is the final gatekeeper. Pharmacists need the tools, financial resources, and time to protect our

Prescription of medicines (POM). These are only available from a pharmacist if they are prescribed by an appropriate doctor.

Certain drugs are classed as prescription only medicines as they have more harmful effects on an individual’s body. They are not available over the counter so to prevent the misuse of these drugs as they can lead to more serious consequences if taken incorrectly. Although, general sales list medicines can also harm an individual when taken in higher quantities, they do not run the same risk of misuse as prescription only medicines and can be self-medicated. General sales list medicines, such as Paracetamol and Ibuprofen, in higher quantities are classed as pharmacy medicines.

prescription, the combining of ingredients to form a drug. Some ingredients had the value but others were worthless or actually harmful.

1.1.1 A prescription is a written instruction from a physician, dentist, etc., to a pharmacist stating the form, dosage strength, etc., of a drug to be issued to a specific patient.

P3 - Explain relevant sections of key legislation and associated guidelines with regard to the administration of medicines

The Medicines Act 1968:- The Medicines Act controls the manufacture and supply of medicines for human and veterinary use. The act defines three categories of the supply of drugs; Prescription only medicines, Pharmacy Medicine, and General sales list medicines the act controls

Legislation – The Medicines Act, Control of Substances Hazardous to Health (COSHH) Regulations, The Health and Safety at Work Act, The Misuse of Drugs Act, The Misuse of Drugs (Safe Custody) Regulations, Health and Social Care Act

Prescription drugs, on the other hand, are medicines that have been approved by the Food and Drug

These categories are Natural remedies such as eating fruits for constipation, Over-the-counter drugs which can be legally bought without a prescription such as Tylenol, Prescription drugs which is an order written by a doctor to a pharmacist which can be many things used for many things, Tobacco products which contain nicotine such as cigars, Alcohol such as beer rum or wine, Illegal drugs which are substances that cannot be legally bought such as weed, and last but not least unrecognized drugs which can be found in products not classified as drugs such as

12. The FDA would not let unsafe replications of drugs onto the market, prescription or over the counter medications

Chapter 3 (context) described the structure and set up of functioning systems such as the UK and EU medicines regulatory examples that have legal frameworks and policies governing pharmacovigilance within the health system. The existence of a policy containing essential statements of PV indicates that a country is committed to improving the medicine safety giving strong direction for advancement of the systems.

Pharmaceutical products, medical devices, veterinary medicines and food supplements, all these products are subjected to regulations stated in the government policies to protect public health. All healthcare organisations or companies are constantly being monitored by a regulatory affairs department or commonly known as regulatory pharmacists to ensure their compliance with all the regulations and laws concerning their business. Regulatory pharmacists always adhere to ethical standards and refrain from abuses of power which make them true leaders who wield their power to achieve desired

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

The finished product need to contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation and are of the purity required.