Please note that these Draft Guidances are NOT FINALIZED; when they become finalized, they will represent the current thinking of the FDA on the specific topics.

Background
One cannot compound regularly or in inordinate amounts drug products that are essentially copies of a commercially available drug product. This guidance explains the following terminology:

• Commercially available,
• Essentially a copy of a commercially available drug product, and
• Regularly or in inordinate amounts.

The second point above does not include a drug product in which there is a change,

• made for an identified individual patient,
• which produces for that patient a significant difference,
• as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug.

Policy Summary
Commercially Available: If it is a marketed drug product.
It is NOT considered commercially available if:

• It has been discontinued and is no longer marketed, or
• It appears on the FDA drug shortage list in effect, is currently in shortage status, and is not resolved.

Essentially a copy: If:

• It has the same API,
• It has the same, similar, or easily substitutable dosage strength, and
• Can be used by the same route of administration.

Unless a prescriber determines that there is a change, made for an identified individual patient, which produces for that patient a significant difference from the commercially available drug product.

More detail can be found along with examples by sourcing a copy of the Guidance at the above URL. It is highly recommended that it be read.

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

Announcement—BPS Certification Petition for Sterile Compounding

Please help gather essential data to support and guide the development of a petition to the Board of Pharmacy Specialties' (BPS) to consider sterile compounding as a pharmacist specialty. The survey can be completed in 5 to 10 minutes. All survey results must be received by Tuesday, January 31, 2017, at 11:30pm ET. To access the survey form, please click on the following link:

https://fs16.formsite.com/jannrx/form12/index.html.

News

Compounding Progress Report Released by the FDA
"FDA's Human Drug Compounding Progress Report"

Three years after enactment of the Drug Quality and Security Act (January 2017)

This is a "must read" for all compounding pharmacists. It can be obtained at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/PharmacyCompounding/UCM536549.pdf

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

Did You Know ...

�that in the responses to the USP <800> questions previously raised in this newsletter, there were:

• 81 questions that were submitted and
• 49 answers provided

However, some of the provided answers were to Questions/FAQs already previously available on the USP website so even fewer questions were actually answered.

Regarding submitted question #52 from this Newsletter:

"Have there been any documented/published studies involving significant harm related to compounding of non-antineoplastic HDs in pharmacies?"

The question seems to have been altered to read:

"Have there been any documented/published studies involving harm related to handling of HDs?

These are obviously different questions!

Tip of the Week

As one can easily read, the question has been changed and the reader is simply referred to the "References section of the chapter."

In looking at the references, there are 45 provided:

• Some dating back to 1980s, but most are more recent
• Many are governmental reports
• Some are organizational practice guidelines
• Some are journal articles

However, none of these answer question #52 cited above. Surely if compounding pharmacies are spending millions and millions of dollars to comply with USP <800>, the justification should be available for all to read. It appears there has been NO valid prospective study related to significant harm from compounding HDs in the literature.

Pharmacists are still waiting for answers to all the other questions so they will know how to prepare. It is unfair to not respond to valid questions to assist pharmacists that are trying to comply, especially if tens of thousands of dollars are spent by a pharmacy and they later find out the state boards of pharmacy interpret the chapter differently and they have to spend tens of thousands of dollars more! If there is no answer, the standard should be revised or removed.

Looking Back

A whiskery kiss,
For the one you adore,
May not make her mad,
But her face will be sore!
     Burma Shave