Please note that this is a FINALIZED document and represents the current thinking of the FDA.

IMPORTANT: OBTAIN A COPY FROM THE ABOVE WEBSITE AND READ IT IN ITS ENTIRETY. BELOW IS ONLY A SUMMARY.

Background
This Guidance does not cover:

• Biological products subject to licensure
• Animal drug products
• Non-prescription drug products
• Radiopharmaceuticals
• Registered repackers, etc.
• Removing drug product from container for immediate administration
• Dispensing
• Investigational new drugs

The FDA regards repackaging as 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. It also includes the act of placing the contents of multiple containers of the same finished drug product into one container, as long as the container does not include other ingredients. If manipulated in any other way, it is not considered repackaging.

Drugs that are repackaged are not subject to sections 503A and 503B of the FD&C Act. Therefore, they are not eligible for the exemptions provided under those sections.

Policy
The FDA does not intend to take action if the drug product is repackaged according to the following conditions:

• The drug product is an approved product or is an unapproved product that appears on the drug shortage list in effect during that time period or for 30 days following.
• Repackaging is in a state-licensed pharmacy, a Federal facility, or an outsourcing facility.
• Repackaging is by or under the direct supervision of a licensed pharmacist.
• It is distributed only after the receipt of a valid prescription for an identified individual patient (Does not apply to an outsourcing facility.).
• Except as provided for a single-dose vial, it is repackaged, stored, and shipped so it does not conflict with approved drug-product labeling.
• The container is suitable for storage through its BUD.
• The same labeling is applied to the repackaged drug product.
• The repackaged drug product is assigned a BUD as described (in the Guidance) unless other information is appropriate and available.
• The drug is repackaged in accordance with USP Chapters <795> and/or <797>; if in an outsourcing facility, in accordance with CGMP requirements.
• The drug product does not appear on a list of drug products that have been withdrawn or removed from the market as unsafe or ineffective.
• The drug product is not sold or transferred by an entity other than the entity that did the repackaging.
• The repackaged product is distributed only in States where the facility repackaging the drug product meets all applicable State requirements.
• For outsourcing facilities, there is an additional list of requirements.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Federal Regulations: "Two Out, One In"
President Trump has signed an executive order requiring all government agencies to eliminate two regulations for every new regulation instituted. The order plans to benefit small businesses and will likely impact the FDA as it applies to every agency except those related to military or national security or other agencies exempted by the Office of Management and Budget (OMB). How a "one in, two out" plan would work with the FDA remains to be understood. According to the Executive Order, this plan will likely also apply to FDA guidance documents.

[Editor's Note: Maybe some of the newer "over-extending" FDA Guidance requirements related to compounding can be deleted�especially since they are marked as "nonbinding recommendations" but are being enforced!]
http://www.raps.org/Regulatory-Focus/News/2017/01/30/26734/%E2%80%98Two-Out-One-In%E2%80%99-Trump-Signs-Executive-Order-to-Repeal-Regulations/

General Chapter <797> Pharmaceutical Compounding-Sterile Preparations will be Posted for Second Round of Public Comments (27-Jan-2017 )

• General Chapter <797> is currently undergoing revision. Initially, the proposed chapter revision was published for public comment from September 25, 2015 to January 31, 2016.
• During the public comment period, the USP received more than 8,000 comments from more than 2,500 stakeholders. The Compounding Expert Committee is currently evaluating all of the information received in the public comments and using these data to inform the chapter revision as appropriate.
• Based on ongoing dialog and the nature and significance of the public comments received, the proposed revised chapter will be republished in the Pharmacopeial Forum for another round of public comments.
• Although General Chapter <797> is undergoing revision, the published version of the chapter which became official on June 1, 2008 is currently the official standard.
• At this time, the USP does not have an anticipated date for the chapter's republication.
• The USP encourages stakeholders to follow the status of the chapter and sign up for the USP Healthcare Quality Standards Update at http://www.usp.org/HQS-Signup-Form. For additional information, you can also visit USP's FAQ page on this chapter.
• Should you have any questions, please contact the USP Healthcare Quality and Safety team at CompoundingSL@usp.org.

http://www.usp.org/usp-nf/notices/general-chapter-pharmaceutical-compounding-sterile-preparations-will-be-posted-second-round-public-comments

NECC Trial Witness Describes "Hijinks" and "Lax Safety Standards"
Barry J. Cadden is facing life imprisonment due to actions at his pharmacy facility where tainted steroids are linked to 64 deaths and hundreds of illnesses. The trial, which began January 9, 2017, is expected to last two or three months. The cleanrooms where sterile preparations were made was an animal house replete with co-workers wrestling, arguing over whether to blare rap or sports talk on the radio, and riding drug carts like bumper cars, a former pharmacy technician recalled at trial. A witness said "Cleaning became much less of a stressed importance." Although physical contact was forbidden and workers were mandated to wear antiseptic suits, boots, and gloves, the witness-whose job was to fill vials with drugs and seal them-told jurors, "We would play jokes on each other, yell and scream, occasionally wrestle-a lot of hijinks." The witness said he even had a hand in pushing another employee down a conveyor belt intended for sterile drugs. The witness said "We could just not keep up with production."
http://www.bostonherald.com/news/local_coverage/2017/01/witness_details_
hijinks_at_necc_lax_safety_standards

[Editor's Note: NECC was not even following basic sterile compounding regulations and standards; they were apparently involved in negligent/criminal activities. However, their actions initiated a kneejerk reaction related to DQSA, USP chapters being strengthened, and the FDA encroaching on state's rights. NECC was breaking the law and individuals like this will disregard laws, regulations, and standards regardless of how strong they are. Stronger and sometimes unrealistic standards will not stop pharmacies like this but will eliminate many patients' access to properly compounded sterile and nonsterile drugs.]

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Did You Know ...

�that websites are getting bigger and bigger and continue to retain "out-of-date" information and posts? This makes it very difficult to navigate and find what is current and important. As an example, go to www.fda.gov.

Tip of the Week

Trying to find a balance between outdated information that needs to be retained on a website for historical/legal purposes and quickly find current and applicable information is an issue. Websites should be organized into "Archived or Historical" information and "Current" information so that upon entering the website, one can easily eliminate a lot of "guessing." Have a website? Keep it updated and easy to navigate!

Looking Back

To steal a kiss,
He had the knack,
But lacked the cheek,
To get one back!
     Burma Shave