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Department of Health and Human Services
OFFICE OF
INSPECTOR GENERALCOMPOUNDED DRUGS UNDER
MEDICARE PART B:
PAYMENT AND OVERSIGHT Daniel R. Levinson
Inspector General
April 2014
OEI031300270EXECUTIVE
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How to fill out compounded drugs under

How to fill out compounded drugs under:
01
Start by gathering all the necessary ingredients and materials for compounding the drugs. This may include active pharmaceutical ingredients, excipients, tools, and equipment.
02
Follow the instructions provided by the prescribing healthcare professional or pharmacist regarding the specific compounding process. This may involve measuring and weighing the ingredients accurately, mixing them thoroughly, and performing any necessary calculations or adjustments.
03
Adhere to proper sterile and aseptic techniques to ensure the safety and effectiveness of the compounded drugs. This may involve using sterile equipment, working in a clean and controlled environment, and following appropriate hygiene practices.
04
Document all the steps and details of the compounding process accurately and clearly. This includes noting down the specific measurements, procedures, and any other pertinent information that may be required for future reference or regulatory purposes.
05
Label the compounded drugs accurately and appropriately, indicating the contents, strength, dosage instructions, and any necessary warnings or precautions.
06
Store the compounded drugs properly in a suitable container, at the appropriate temperature and conditions as specified by the compounding guidelines or the healthcare professional or pharmacist.
07
Dispose of any waste or unused materials from the compounding process in a safe and responsible manner, following the applicable regulations and guidelines.
Who needs compounded drugs under:
01
Patients with specific medication needs: Compounded drugs may be necessary for individuals with unique medical conditions or requirements that cannot be met by commercially available medications. This can include customized dosages, alternative dosage forms (such as creams or gels), or the removal of allergenic or unnecessary ingredients.
02
Veterinary patients: Animals, including pets and livestock, may require compounded drugs for various reasons, such as receiving medication in a different form or dosage that suits their specific needs.
03
Individuals with allergies or intolerances: Compounded drugs can be beneficial for patients who have allergies or intolerances to certain ingredients commonly found in commercial medications. By customizing the formulation, these individuals can receive the necessary treatment without any adverse reactions.
04
Pediatric patients: Children may require compounded drugs due to challenges with swallowing pills, a need for lower dosages, or the absence of commercially available formulations suitable for their age group.
05
Hospice and palliative care patients: Individuals receiving end-of-life care or managing a terminal illness often require compounded medications to address their unique symptoms and needs.
Remember to always consult with a healthcare professional or pharmacist to determine if compounded drugs are appropriate and safe for a specific individual's situation.
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What is compounded drugs under?
Compounded drugs refer to medications that are customized or mixed by a pharmacist based on a prescription.
Who is required to file compounded drugs under?
Pharmacists or pharmacies that engage in compounding drugs are required to file compounded drugs under.
How to fill out compounded drugs under?
Compounded drugs can be filled out by providing information on the ingredients used, compounding process, and intended use of the medication.
What is the purpose of compounded drugs under?
The purpose of compounded drugs is to provide personalized medications for patients with specific needs that cannot be met by commercially available drugs.
What information must be reported on compounded drugs under?
Information such as ingredients used, compounding process, patient information, prescribing physician, and dispensing pharmacist must be reported on compounded drugs.
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