Which agency holds the legal responsibility for deciding whether a drug may be distributed or sold?
§ 301 et seq., grants the Food and Drug Administration (“FDA”) the authority to regulate all “drugs” and “devices,” which include any “arti- cles (other than food) intended to affect the structure or any function of the body,” as well as any components of such articles.
Who is the person licensed to prepare and dispense drugs?
pharmacistA pharmacist is an individual licensed to prepare, compound, and dispense drugs/medications upon written or electronic order (prescription) from a licensed practitioner such as a physician, dentist, advanced practice nurse or physician assistant.
Which agency enforces the laws that assure the safety effectiveness and proper labeling of drugs quizlet?
What does the Food and Drug Administration do? The FDA is a federal agency that enforces guidelines to ensure the safety and effectiveness of medication manufacturing. The FDA also approves new medications for use.
What is it called when drugs are injected through a syringe into a muscle vein or body cavity?
Intramuscular (IM) chemo The drug is put into a muscle through a needle that's attached to a syringe (as an injection or shot).
Who is responsible for drug production?
Pharmaceutical scientists usually specialize in one aspect of the drug development process. They may: Design new drug therapies using natural or synthetic (man-made) ingredients.
Who has the authority to give the proprietary name of a drug?
The brand name is developed by the company requesting approval for the drug and identifies it as the exclusive property of that company. When a drug is under patent protection, the company markets it under its brand name.
What agency is responsible for the drug production and drug safety?
As a regulatory agency under the Department of Health, the Food and Drug Administration, created under Republic Act No.
Which agency decides if drugs are safe and effective?
At this stage, the FDA decides whether it is reasonably safe for the company to move forward with testing the drug in humans. Clinical Trials--Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB).
What organization is responsible for ensuring that drugs are safe?
FDA Mission The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Which of the following are parts of the basic rights of drug administration quizlet?
The six basic rights of medication administration include right patient, right drug, right dose, right route, right time, and right documentation.
Which type of drug administration includes all of the ways a drug may be administered except via the digestive tract?
Parenteral drug administration refers to drugs given by routes other than the digestive tract. The term parenteral is usually used for drugs given by injection or infusion. The enteral route usually refers to taking drugs by mouth.
What is the route of administration when a drug is directly applied to the skin?
Subcutaneous injections are another form of the parental route of medication and are administered to the layer of skin referred to as cutis, just below the dermis and epidermis layers. Subcutaneous tissue has few blood vessels; therefore, the medications injected undergo absorption at a slow, sustained rate.
Who can dispense medicines?
Prescription-only medicines, such as antibiotics, must be prescribed by a qualified health professional. This may be a GP, hospital doctor, dentist, nurse, pharmacist, optometrist, physiotherapist or podiatrist.
What is a dispensing license?
The Regulations states that a doctor can only dispense his or her own prescription. This means that the doctor without a licence would need to write a prescription to be taken to a pharmacy. Otherwise the second doctor must have a dispensing licence too if they intend on dispensing.
Who can dispense the drug in hospital?
42 of the Pharmacy Act is very clear. The dispensation of medicine can only be done by a qualified pharmacist and a medical practitioner for his own patients or with the general or special sanction of the State Government for the patients of another medical practitioner.
Who is dispensing pharmacist?
Dispensing refers to the process of preparing and giving medicine to a named person on the basis of a prescription. It involves the correct interpretation of the wishes of the prescriber and the accurate preparation and labelling of medicine for use by the patient.