How are radiopharmaceuticals regulated?

How are radiopharmaceuticals regulated?

All radiopharmaceuticals administered to patients must be approved for use by the U.S. Food and Drug Administration (FDA). The FDA, part of the Department of Health and Human Services, regulates diagnostic radiopharmaceuticals based on 21 C.F.R. §§ 315.1–315.6 and 601.30–601.35.

What are the requirements of a radiopharmaceutical?

The radiopharmaceutical should comply with the requirements set out in a monograph of a pharmacopoeia or in an in-house monograph. Such requirements are related to radioactivity, identity, radionuclidic, radiochemical and chemical purity, sterility and apyrogenicity, pH, isotonicity, level of residual solvents.

What is the preparation of radiopharmaceuticals?

The preparation of radiopharmaceuticals involves three basic steps: production of the radionuclides, synthesis of the non-radioactive compound and reaction of the radionuclide with the non-radioactive compound.

Which agency regulates the dispensing of radiopharmaceuticals?

Also, because they are prescription drugs, radiopharmaceuticals fall under the control of the U.S. Food and Drug Administration (FDA).

What are the federal regulatory limits on radioactive release?

The NRC’s final layer of protection of public health and safety limits radiation doses to 100 mrem per year for individual members of the public. This limit applies to every civilian facility that uses radioactive material.

Where are radiopharmaceuticals prepared?

Radiopharmaceuticals contain small amounts of radioisotopes that can be produced by irradiating a specific target inside a nuclear research reactor or in particle accelerators, such as cyclotrons.

How do you label radiopharmaceuticals?

container of a radiopharmaceutical shall also be labeled with: (1) The standard radiation symbol; (2) The words “CAUTION – RADIOACTIVE MATERIALS”; (3) The radionuclide of the radiopharmaceutical contained therein; (4) The chemical form of the radiopharmaceutical contained therein; (5) The amount of radioactivity of the …

What makes a good radiopharmaceutical?

The ideal radiopharmaceutical should have a short or long physical half-life time depending on what the property is being used for. The half-life time is the amount of time it takes for the radioactive nuclei used to decay to half of its radioactive lifespan.

What is radiopharmaceuticals PDF?

Radiopharmaceuticals, as the name suggests, are pharmaceutical formulations consisting of radioactive substances (radioisotopes and molecules labeled with radioisotopes), which are intended for use either in diagnosis or therapy or diagnosis.

Which of the following is allowed when preparing immediate use radiopharmaceuticals?

PREPARATION OF RADIOPHARMACEUTICALS FOR IMMEDIATE USE Preparation components must be sterile FDA-approved kits, the finished product must be limited to use for a single patient, and the finished product must be administered within 1 h of the first vial puncture that started the radiolabeling procedure.

Does OSHA cover radiation?

OSHA requires employers to protect workers from exposure to ionizing radiation sources that are not regulated by the NRC or other federal agencies, such as X-ray equipment, some accelerators, incidental accelerator-produced radioactive materials, ion implanters, and some naturally-occurring radioactive material (NORM).

How are radiopharmaceuticals dispensed?

All radiopharmaceuticals dispensed and administered must be pursuant to an order (e.g., prescription) by an authorized physician. The order should specify the procedure desired, the drugs to be used, the amounts to be administered, the route of administration, and, if applicable, the rate of infusion.

What is a radiopharmaceutical made of?

A radiopharmaceutical can be seen as an entity made up of a radionuclide and a vehicle molecule with high affinity – or binding power – for a tissue or a specific function of a human organ. It may also comprise only the radioisotope itself if it shows suitable biological properties.

How do you store radiopharmaceutical medicine?

In addition to well-closed containers and storage areas designated for this purpose, radiopharmaceuticals should be stored in well-ventilated areas. Stored materials should be stored in a manner that will reduce the maximum radiation dose rate to which a person is exposed to an acceptable level.

What are radiopharmaceutical agents?

Radiopharmaceuticals are agents used to diagnose certain medical problems or treat certain diseases. They may be given to the patient in several different ways. For example, they may be given by mouth, given by injection, or placed into the eye or into the bladder.

How do you store radiopharmaceuticals?

What are the requirements of USP 797?

Designed to protect both patients and pharmacists, USP 797 requires attention to three main areas to ensure compliance: staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures.

Who can order radioactive materials?

the general public
By regulation, the general public is allowed to order these materials without possessing a radioactive materials license, so vendors will sell these compounds directly to any customer. However, educational institutions are not allowed to possess more than 3.3 pounds of uranium or thorium at any one time.