About Sollers

Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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Sollers Blog

What Are the FDA’s New Compounded Drug Guidelines?

Posted by Phil on Nov 14, 2016 11:11:07 AM

The FDA aims to protect the health of U.S citizens’ by assuring them safe and secure drugs as well as biologics. However, the agency is hampered by the limitation that it can only authorize drugs which cross the state lines. Activities which occur within the boundary of a state are often governed through various other means, like the state boards of pharmacy. However, the FDA has the authority to intervene, when there is a high risk to the population or if any important law is broken.

What Is the FDA Doing to Curb Malpractices in Compounded Drugs Business?

The FDA has begun developing strategies for helping to curb the malpractices in the industry’s regulatory framework. Examinations regarding various regulations have revealed many weak areas which include the apparent lax operations in the pharmacies regarding dispensed drugs, parenteral as well as retaining the sterility of the materials. Many pharmacies dispense prescription drugs without getting prescriptions.

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The FDA is acting to protect the health of the people. They are also checking the regulation of other areas which include traditional pharmaceutical manufacturing, having various health risks. Many FDA actions can encourage or discourage activities in this sector which could have a significant impact on the industry’s operations.

The New FDA Guidelines for 2016

There are newly issued guidelines which cover pharmacies in the 503A and 503B areas. Every document covers a specific type of situation, by attempting to clarify as well as define the new rules by which the compounding pharmacies would work. There are various requirements which must be met for exempting a compounder from the general FDA requirements. These include the inclusion of a valid prescription, conditions which will allow compounding, office use, distribution, etc.

The new guidelines also explain what type of drugs can be and cannot be used. There are various requirements which a drug must meet like the substance must be a part of an approved product, it must have a valid certificate of analysis, it must not be on the non-usable list of drugs which are banned due to safety issues. The new guidelines also state the disciplinary actions which will be undertaken if any compounder is found to not work by the newly implemented rules. 

Topics: Drug Safety