The FDA has released its guidance plan for what guidance documents they will release in 2016. Let’s examine each one in details.

Do not miss the DSCSA deadline. It is the most important deadline in the entire pharmaceutical industry so know about it in details.

Know how the DSCSA guidance for Pharmaceutical Labelling can prevent counterfeit drugs to enter into the legal supply chains within the industry.

The Healthcare Distribution Management Association (HDMA) represents primary pharmaceutical distributors who take products from pharmaceutical manufacturers and deliver it to healthcare providers.

Wholesale distributors and third-party logistics providers (3PLs) are required to be licensed by the FDA. Know who is a licensed wholesale distributor or 3PL because the FDA maintains a list of them.

FDA posted new guidance called “Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy; Guidance for Industry“

Know how the DSCSA T3 differs from the Drug Pedigree solutions in the US pharmaceutical market. Get all the relevant information about the two.

Know how the third-party logistics providers can play their roles in the pharmaceutical supply chain and how you can mould according to the requirements and regulations.

The physicians also need to be abided by the DSCSA laws in the pharmaceutical industry. Know in details how the law protects the needs of each patient.