Ensuring Supply Continuity for Medically Necessary Drug Products Your Game Plan for Compliance and Supply Chain Assurance
Product Details
The ink is barely dry on the draft MNP guidance, and the pressure is already on many drug and biologics manufacturers to develop emergency plans to meet FDA requirements. Here’s how to get up to speed — fast.
In January 2010, the FDA released a draft guidance that requires manufacturers of medically necessary drug products (MNPs) to have specific emergency plans — and corresponding SOPs — for each of their facilities in case of supply chain disasters or high absenteeism.
The guidance says emergency plans should be developed, written, reviewed and approved within a site’s change control quality system under the requirements of 21 CFR 211.100 and 211.160. In addition, a broader plan should address the potential for shifting operations, resources or personnel across multiple sites.
What exactly is a medically necessary product? The FDA calls a product medically necessary if it falls into one of four categories:
- Where the company is the sole source of the drug or the drug supports a significant share of the U.S. market
- Antiviral drugs that may be needed during a pandemic
- Drug products for conditions such as diabetes, high blood pressure, congestive heart failure, asthma and cancer
- Products that are especially vulnerable to shortage because of typically low inventory levels in the supply chain
Because the guidance provides only a general outline and simple overview of the steps required to implement the plans, manufacturers are left with the difficult responsibility of adapting the guidance for their facilities without any details of how to go about doing it.
Fortunately, help is at hand.
Mark your calendar now for this 90-minute webinar on Tuesday, April 20. It’s all you need to get up to speed on the FDA guidance, “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.”
Your guide through the draft guidance is Jack Garvey, a leading lawyer and consultant on FDA compliance matters. In 90 information-packed minutes, he’ll spell out precisely how you can adapt its provisions to fit your facilities. Here’s just a taste of what he will cover:
- The definition of medically necessary product (MNP)
- The FDA’s Drug Shortage Program — what it is, what are its implications
- The 7 main elements of the MNP draft guidance
- Which elements are “requirements-oriented” and which are “goal-oriented”
- What the FDA notice provisions are
- How and where to direct notice to the FDA in event of a plan activation
- Resolving conflicts between guidance provisions and business continuity planning
- Developing a plan: Suggested elements and components
- Testing the plan for effectiveness: What the FDA expects
- And much more
This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.
Everyone in your organization with a role in medically necessary drug products deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate.
Don’t let this latest FDA draft guidance trip you up. Turn to an expert to learn what you — and your staff — need to know. Sign up today!