What is a Multiple Source Drug? A Comprehensive Legal Overview

Q: How can I find out if my medication is a multiple source drug?

You can check the FDA&#039;s publication of approved drug products or consult with your pharmacist or healthcare provider.

Q: Are multiple source drugs always cheaper than brand-name drugs?

Generally, yes, multiple source drugs tend to be less expensive, but prices can vary based on insurance coverage and pharmacy pricing.

Definition & Meaning

A multiple source drug is a medication that is available from both a brand-name manufacturer and multiple generic manufacturers. This means that there are at least two different products that are considered therapeutically equivalent, meaning they work the same way in the body and have the same clinical effect. These drugs must also meet specific standards set by the Food and Drug Administration (FDA) regarding their formulation and effectiveness.

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Legal Use & context

The term "multiple source drug" is primarily used in the context of healthcare law and regulations, particularly in relation to Medicaid and pharmaceutical pricing. It is relevant in discussions about drug reimbursement and pricing strategies, as well as in legal frameworks governing the approval and marketing of medications. Users may need to navigate forms or procedures related to drug coverage, which can often be managed through legal templates available from services like US Legal Forms.

Key legal elements

Real-world examples

Here are a couple of examples of abatement:

For example, a brand-name medication like Lipitor, which is used to lower cholesterol, has multiple generic versions available. These generics are considered multiple source drugs because they are therapeutically equivalent and have been approved by the FDA.

Relevant laws & statutes

One key statute that defines multiple source drugs is 42 USCS § 1396r-8(k)(7)(A)(i). This law outlines the criteria for what constitutes a multiple source drug in relation to Medicaid drug rebates and pricing.

Comparison with related terms

Term	Definition	Difference
Generic Drug	A medication that is equivalent to a brand-name drug in dosage form, strength, route of administration, quality, and performance characteristics.	All multiple source drugs are generic, but not all generics are classified as multiple source drugs.
Brand-name Drug	A drug marketed under a proprietary, trademark-protected name.	Multiple source drugs include both brand-name and generic options.

Common misunderstandings

What to do if this term applies to you

If you are navigating issues related to multiple source drugs, consider reviewing your medication options with your healthcare provider. You may also want to explore legal form templates available through US Legal Forms to assist with any necessary documentation. If your situation is complex, seeking advice from a legal professional may be beneficial.

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Quick facts

Attribute	Details
Typical Fees	Varies based on the medication and insurance coverage.
Jurisdiction	Federal and state regulations apply.
Possible Penalties	Potential for reduced reimbursement rates under Medicaid.

Key takeaways

Frequently asked questions

What is the difference between a generic drug and a multiple source drug?

A generic drug is simply a non-brand version of a medication, while a multiple source drug specifically refers to drugs that have both brand-name and generic versions available.