Please note that this is a DRAFT GUIDANCE and is distributed for comment purposes only.

IMPORTANT: OBTAIN A COPY FROM THE ABOVE WEBSITE AND READ IT IN ITS ENTIRETY AND COMMENT AS DESIRED.

NOTE: This is Part II of the summary for this Draft Guidance.

C. Licensed Allergenic Extracts for Subcutaneous Immunotherapy

The FDA recognizes that there are circumstances where licensed allergenic extracts would be mixed and diluted to provide subcutaneous immunotherapy to an individual patient, even though these allergenic extract combinations are not specified in the approved BLAs. These combinations are called "prescription sets."

A prescription set is defined as a vial or set of vials of premixed licensed standardized and non-standardized allergenic extracts for subcutaneous immunotherapy diluted with an appropriate diluent prepared according to instructions from a valid prescription by a licensed physician for an individual patient.

Policy

The FDA does not intend to take action if the physician, pharmacy, Federal facility, or outsourcing facility prepares prescription sets of allergenic extracts in accordance with the conditions described below. (Note: Item 2 is missing in the FDA document-02/16/17).

The prescription set is:

• prepared from FDA-licensed allergenic extracts and appropriate diluents.
• prepared in a physician's office, state-licensed pharmacy, Federal facility, or outsourcing facility.
• distributed only after the receipt of a valid prescription for an identified, individual patient directly from the prescribing practitioner or patient.
• prepared in a way that does not conflict with approved labeling of the licensed biological products that are part of the prescription set.
• assigned a BUD of no later than the earliest expiration date of any allergenic extract or any diluent that is part of the prescription set, and the BUD does not exceed one year from the date the prescription set is mixed or diluted.
• prepared in accordance with USP Chapter <797>, except the BUD is as specified in the document (Condition 5), or it is prepared in an outsourcing facility with applicable CGMP requirements except the BUD is as specified in the document (Condition 5).
• not sold or transferred by an entity other than the entity that prepared the prescription set.
• distributed only in states in which the facility preparing the prescription set meets all applicable state requirements.
• prepared by an outsourcing facility according to the criteria in the draft guidance, item "10".

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

FDA Recalls Ibuprofen Lysine Injection Due to Foreign Matter
A lot of ibuprofen lysine injection 20 mg/2 mL has been recalled by Exela Pharma Science, in association with X-Gen Pharmaceuticals, Inc., because of the presence of particulate matter in some of the vials; this includes Lot number PLND1613, National Drug Code (NDC) 39822-1030-2, and an expiration date of February 2018. It was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.
http://www.medscape.com/viewarticle/875604

Healthcare Executive Philip Esformes Charged in $1B Fraud and Bribery Cases
In addition to conspiracy, obstruction, money laundering, and healthcare fraud, Philip Esformes now faces charges of bribery. Esformes is owner of Esformes Network which includes a chain of more than 30 skilled-nursing and assisted-living facilities in Miami, Florida. He and his two conspirators are charged with stealing $1 billion through an elaborate kickback scheme which funneled patients between various Miami healthcare facilities.
http://www.fiercehealthcare.com/healthcare/notorious-healthcare-ex-charged-1b-fraud-plan-now-accused-bribery

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Did You Know ...

�that Marathon Pharmaceuticals announced a price for its new Duchenne muscular dystrophy drug at $89,000 per year this week and a couple of days later withdrew it.

Tip of the Week

The $89,000 per year price of the drug attracted a congressional backlash and Marathon Pharma stopped their launch, even before it was to begin. The drug, deflazacort, an antiflammatory corticosteroid, is decades-old (1986), and the company did not even develop the drug but acquired rights to trial data from the 1990s. In Canada and the European Union, it is priced at about $1,000 per year.

As it has been said before, "Question Everything!" and it may help to stop such abuses.

Looking Back

Beneath this stone,
Lies Elmer Gush,
Tickled to death,
By his shaving brush!
     Burma Shave