FDA Issues Final Guidance Addressing Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
Posted: 18 Jan 2017 08:51 PM PST
By Karla L. Palmer –
On December 29, 2016, FDA issued final guidance reflecting its policy on Repackaging of Certain Human (Prescription) Drug Products by Pharmacies and Outsourcing Facilities, first issued in draft form in February of 2015, and blogged here. FDA’s final guidance highlights certain sections because it includes information still subject to review (collection of information) by the Office of Management and Budget. FDA’s Federal Register Notice announcing the guidance seeks comments by February 17, 2017. FDA is still considering applicability of these policies to hospitals and healthcare systems, which it intends to address in yet another guidance document. FDA also issued a separate (revised draft) guidance document on repackaging of biological products, which will be the subject of a separate blog post.
Like the draft guidance, this guidance defines “repackaging:” The act of “taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug.” Repackaging also includes placing contents of multiple finished drug containers (e.g., vials) into one container, “as long as the container does not include other ingredients.” FDA notes that “if the drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed, or combined with another ingredient,” then it is not considered repackaging. The Agency states, for example, that if tablets are removed from a blister pack and placed in a different container, then that would be considered repackaging. However, if the blister packs are placed into a different container for later use (leaving the blister packs intact) then that would not be repackaging.
FDA’s guidance (like the earlier draft) describes generally the approval process for drugs, including FDA’s required review and approval of drug container closure systems. Repackaging may alter the characteristics of drug products in ways that FDA did not consider during the drug approval process, affecting stability, safety and efficacy. FDA notes that repackaged drugs are not subject FDCA’s exemptions in Sections 503A and 503B; thus FDA’s guidance describes when FDA will exercise enforcement discretion concerning stats-licensed pharmacies, federal facilities and outsourcing facilities that repackage drugs. Some highlights of the guidance include:
FDA Clarifies Compliance Date and other Aspects Concerning the Final Rules for the Nutrition Facts Label and Serving Size
Posted: 18 Jan 2017 05:33 PM PST
By Riëtte van Laack –
As we previously reported, FDA issued final rules updating the nutrition labeling regulations, 21 C.F.R. §§ 101.9 and 101.36, and the serving size regulation, 21 C.F.R. § 101.12, on May 27, 2016. Despite the rather extensive preamble, the final rules left many questions unanswered. FDA promised to address a number of issues in guidance. The timing of that guidance is crucial because the compliance date for the final rules is July 26, 2018 (smaller businesses with annual food sales of less than 10 million dollars have until July 26, 2019).
Early in August, 2016, FDA created a webpage with industry resources which provided some answers. Then, on January 4, 2017, FDA announced the availability of two arguably overdue draft guidance documents: a draft guidance clarifying aspects of the final rule regarding nutrition labeling, and a draft guidance providing examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) used to determine serving size.
The draft guidance concerning nutrition labeling answers questions about the nutrition labeling rules and the compliance date. Topics addressed include:
The draft guidances are accessible on the industry resources webpage. That page also includes a link to the draft guidance for Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (Comments due February 13, 2017).
Comments to the draft guidances are due March 6, 2017.
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