Although federal law still prohibits the use of marijuana for recreational and medical applications, many states have passed laws okaying the use of medical marijuana.
Many companies are emerging that not only specialize in the sale of medical grade marijuana but cannabis oil and other derivatives of the drug for medicinal purposes.
For businesses wanting to get in on this new and growing segment of the drug industry, complying with the federal Food & Drug Administration’s regulations can be complicated. Fortunately, companies can become compliant by focusing on three things.
Product Safety
The primary concern that many patients and the FDA have regarding medical marijuana is its safety. If your business engages in research and development of medical marijuana products, then it will need effective change control and risk management processes.
These processes are part of the FDA’s Current Good Manufacturing Practices, or CGMP, regulations. The regulations ensure that drug products are safe to use and contain the ingredients and strength that they claim.
The FDA also reviews information about proposed medical marijuana products to make sure they can be approved by meeting statutory standards.
Automate Document Control
Receiving regulatory approval for manufacturing any drug product requires a host of documentation. From the initial IND or Investigational New Drug, application to research and development of products, it is essential to implement good document control.
If your company is small, it may not have a compliance officer to help ensure that documents from the FDA are correctly written, in order, and easy to find when necessary. Bad document control could cause setbacks in the approval process.
Fortunately, if there are problems and your business needs help complying with FDA regulations, such as responding to letters from the FDA or reviewing labels, the FDA consulting firm Emma International can help.
They can give your business advice about how to respond to letters and regulatory submissions, do reviews on product information, and perform mock inspections. They can help businesses of any size with their FDA compliance issues.
Create a Collaborative Environment
Along with meeting FDA expectations, your company will also need to work with other federal agencies to get approval to offer medical marijuana products for sale.
The other agencies you’ll need to work with include the Drug Enforcement Agency, the National Institute on Drug Abuse, and the National Institutes of Health.
It is important to create a collaborative environment from the start to make it easier to work with others. Along with federal agencies, this could include compliance consultants, regulators, and personnel involved with clinical trials.
A collaborative atmosphere not only makes the approval process more efficient, but it usually leads to better treatments for patients. During their research, companies often discover the right doses to treat diseases for which their products are designed successfully.
Complying with FDA regulations and getting approval for drugs made from marijuana or cannabinoids takes years of research, development, and collaboration with several agencies and personnel.
To help streamline the process, companies need to focus on the safety of their products, creating a collaborative atmosphere and automating a system for document control.
It takes years for any drug to go through the approval process, but these three steps can make it less difficult.
Melissa Bell
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