Please note that this is a DRAFT GUIDANCE and is distributed for comment purposes only.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NOTE: Due to its length and content, this Draft Guidance will be covered in two parts.

Background
This Guidance does NOT address the following:

• Biological products not subject to licensure under section 351 of the PHS Act.
• Radioactive biological products.
• Mixing, diluting, or repackaging biological products (other than allergenic extracts) by entities that are not state-licensed pharmacies, Federal facilities, outsourcing facilities, or physicians.
• Removing a biological product from the original container at the point of care for immediate administration to a single patient after receipt of a valid patient-specific prescription or order for that patient.
• Diluting or mixing a biological product at the point of care for immediate administration to a single patient after receipt of a valid patient-specific prescription or order for that patient.
• Mixing, diluting, or repackaging a licensed biological product when the product is mixed, diluted, or repackaged in accordance with the approved BLA as described in the approved labeling for the product.
• Mixing, diluting or repackaging of blood and blood components for transfusion, vaccines, cell therapy products, or gene therapy products.
• Investigational new drugs being studied under an Investigational New Drug Application.

"Biological product" is defined as:

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Policy

The FDA does not intend to take action if a state-licensed pharmacy, a Federal facility, or an outsourcing facility mixes, dilutes, or repackages a biological product in accordance with the conditions described below, as follows:

• The biological product that is mixed, diluted, or repackaged is an FDA-licensed biological product.
• The biological product is mixed, diluted, or repackaged in a State-licensed pharmacy, a Federal facility, or an outsourcing facility.
• The biological product is mixed, diluted, or repackaged by or under the direct supervision of a licensed pharmacist.
• The biological product is mixed, diluted, or repackaged only after the receipt of a valid prescription for an identified, individual patient directly from the prescribing practitioner or patient. This does not apply to an outsourcing facility.
• Except as noted in the draft, the biological product is mixed, diluted, or repackaged, and stored and shipped in a way that does not conflict with the approved labeling for the licensed biological product.
• The container is suitable for storage of the biological product through its BUD.
• If the labeling for the licensed biological product includes storage and/or handling instructions, the labeling for the biological product that is mixed, diluted, or repackaged specifies the same storage conditions.
• The duration of time from beginning to end of mixing, diluting, or repackaging is no more than four hours.
• The mixed, diluted, or repackaged biological product is given a BUD that is not longer than the applicable BUD specified in the draft.
• The biological product is mixed, diluted, or repackaged in accordance with the following:
  1. The procedures are done in accordance with USP Chapter <797>, except the BUD is as specified in condition 9 above.
  2. The procedures in an outsourcing facility are done in accordance with CGMP requirements, except the BUD is as specified in condition 9.
• The biological product is not sold or transferred by an entity other than the entity that mixed, diluted, or repackaged the biological product.
• The biological product is distributed only in states in which the facility mixing, diluting, or repackaging the product meets all applicable state requirements.
• If the biological product is mixed, diluted, or repackaged by an outsourcing facility there are many items that are required listed in the draft guidance.

NEXT WEEK: Part II will discuss the mixing and/or diluting of licensed allergenic extracts for subcutaneous immunotherapy.

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

e-Discontinuation of e-Prescribed Prescriptions
e-Prescribing is firmly in place but some insist that e-discontinuation cannot be ignored any longer. Their claim of short-sightedness involves not being able to cancel a medication order through the same electronic systems that allow doctors to write prescriptions without paper. As pharmacies are ramping up efforts to remind customers about refills, the absence of e-discontinuation could result in medication errors. Accompanying the situation of customers being able to refill prescriptions that providers no longer want them to take, there is more opportunity for mix-ups between the physician and the pharmacy as well as between the pharmacy and the customer. On a positive note, the infrastructure to support e-discontinuation has long been ready, if underused.
http://jamanetwork.com/journals/jama/article-abstract/2600477

Judge Denies NECC's Cadden's Motion to Throw Out Key Phone Evidence
The judge presiding over the second-degree murder trial of NECC executive swiftly rejected a motion to strike from the record testimony from a key prosecution. At issue is testimony where Wendy Huffman told jurors that Barry Cadden called her on September 21, 2012 to let her know there might be a problem with steroids shipped from his company. She testified that the call was made five days before NECC initiated a voluntary nationwide recall of over 10,000 vials of methylprednisolone acetate.
http://framingham.wickedlocal.com/news/20170207/necc-trial-judge-denies-barry-caddens-motion-to-throw-out-key-phone-evidence

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Did You Know ...

�that we should "read carefully!"?

Tip of the Week

As pharmacists, we are trained to carefully read prescriptions, medical information, etc. How about other items? Do we read them carefully? There are different levels of reading from "scanning" to "in-depth reading." One cannot just scan important documents; they require in-depth reading�this is especially true of state board of pharmacy documents, USP documents, FDA documents, etc. It may take a few minutes longer, but will pay off in the long run!

Looking Back

We've made grandpa,
Look so trim,
The local draft board,
Is after him!
     Burma Shave