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  • Regulatory NewsRegulatory News

    BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics

    The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics. While both organizations say the revised draft guidance is a step in the right direction, BIO says several aspects of the guidance still raise concerns. Background FDA first issued its draft guidance on mixing, diluting or repackaging biological...
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    Drug Compounding With Bulk Substances: FDA Offers Interim Policies

    The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs. The policies also clarify that the two guidance documents do not apply to inactive ingredients, which can be used in compounding without appearing on the bulk drug substances lists dev...
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    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
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    GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

    A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain. Background Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act . These exemptions allow compounders operating under section 503A of the act to produce drugs w...
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    New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities

    The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. The safety of compounded drugs has been a high profile issue for FDA since 64 people were killed by a fungal meningitis outbreak tied to the New England Compounding Center , a Massachusetts-based compounder, in 2012. Since then, both Congress and FDA have taken steps to improve the safety of compounded ...
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    FDA to Drug Compounders: Inspection Changes Coming in August

    The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up. For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators wi...
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    FDA to Restrict Compounders from Making Copies of Commercially Available Drugs

    The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs. The draft guidance documents – which apply to pharmacies, physicians, federal facilities and outsourcing facilities – are focused on compounded drugs, which the agency says pose a higher risk to patients than FDA-approved drugs because the agency...
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    Three New FDA Draft Guidance Documents for Drug Compounders

    On Friday, the US Food and Drug Administration (FDA) released three draft guidance documents for drug compounders. The guidance describes FDA’s interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act (FD&C Act), how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the definition of the term “facility," in reference to section 503B of the FD&C Act. The draft guidance d...
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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
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    Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

    Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...
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    Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions

    The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded. Background The  Drug Quality and Security Act (DQSA)  of 2013 was passed in the wake of a deadly outbreak of fungal meningitis caused by  deficient compounding practices  at a Massachusetts-based company. Historicall...
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    NIH Suspends Drug Production Unit After FDA Inspection Finds Major Problems

    Pharmaceutical companies frequently find themselves sanctioned by the US Food and Drug Administration (FDA) for failing to adhere to federal good manufacturing practice (GMP) requirements. But it's an exceptionally rare occurrence to see FDA cracking down on a fellow federal government agency, as it is this week. On 4 June 2015, the National Institutes of Health (NIH) issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) ...