Any active pharmaceutical ingredient (API) included in the above-listed drug products.Prescription drug products that are life-supporting, life-sustaining, or intended to prevent or treat a debilitating diseases or condition, including drugs used in emergency medical care or during surgery, or any drug that is critical to the public health during a public health emergency.Drug shortages continue to occur and at roughly the same levels since 2018,” said the guidance.įDA proposes that three types of drug product be required to have an RMP: “Although the number of new drug shortages has declined significantly since the peak in 2011, reaching a low in 20, this downward trend did not continue in subsequent years. Yet FDA said that even with those new authorities, it has not been successful in eradicating the problems that cause drug shortages. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) gave the agency new authorities to prevent or mitigate shortages. The draft guidance aligns with the principles in the International Council for Harmonization (ICH)’s Q9 guidance on quality risk management.ĭrug shortages have been a concern even before the pandemic, and in recent years there has been increased focus on the issue from FDA and Congress. As a general matter, the agency believes that RMPs are a good practice to help ensure reliability of supply of drug products and APIs” and recommends these plans even be in place for drugs that are not subject to the requirements of 506C(j). The law added a new section 506C(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) requiring certain manufacturers to develop and implement a “redundancy risk management plan” to evaluate the potential for drug shortages.įDA said that RMPs are a “useful tool to facilitate compliance with a firm’s regulatory requirements.
Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), FDA was given new authorities to collect information from manufacturers in responding to pandemic-prompted shortages. The guidance also recommends risk factors to consider when developing the content of the RMPs. The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting.
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