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
Pharmacies within a hospital or standalone pharmacies that are part of a health system often provide compounded drug preparations for administration within the hospital or health system.

Hospital and health system drug compounding and distribution practices vary; some compound for use within their hospital and others compound for use within their "hospital system."

Policy Summary

• Section 503A does not distinguish between standalone pharmacies and pharmacies within hospitals and health systems.
• Provisions of 503A apply to pharmacists, pharmacies, and physicians that compound drugs within a hospital or a health system that is not registered as an outsourcing facility under section 503B.
• Drug products compounded not in accordance with all the provisions of section 503A may be subject to regulatory action for violations of the new drug approval, adequate directions for use, and cGMP requirements of the FD&C Act.
• Compounding must either be (a) after the receipt of a valid prescription or order for an identified individual patient, or (b) in limited quantities in advance of receipt of a valid prescription or order for an identified individual patient, and the drug must be distributed after receipt of the prescription or order.
• However, the FDA does not intend to take action under certain situations.
• A "1-mile radius" limitation is intended to distinguish a hospital campus from a larger health system.
• A compounder can register as an outsourcing facility if it intends to provide compounded drugs to facilities such as other hospitals or clinics outside the 1-mile radius of the pharmacy in which the drug is compounded without first obtaining a prescription for an identified individual patient. If registering as a 503B facility and to qualify for the exemptions, the facilities must comply with cGMP 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

Starting in February

PGx 101 in 5
("Pharmacogenomics 101" in 5 minutes a week)

A series on implementing pharmacogenomics in pharmacy/compounding pharmacy that requires up to about 5 minutes reading per week.

News

NECC Cadden Murder Trial Begins Jury Selection
Jury selection has begun in the trial of a former top executive at NECC compounding pharmacy blamed for a national meningitis outbreak that killed 64 people in 2012. Barry Cadden is charged with 25 counts of second-degree murder and other offenses. The prosecution alleges that NECC used expired ingredients and failed to follow industry cleanliness standards.
http://hosted.ap.org/dynamic/stories/U/US_MENINGITIS_OUTBREAK

Drug Approvals Lowest Since 2010
2016 drug approvals were sharply down from 2015 and were the lowest in six years. The FDA only approved 22 new medications, after approving 45 new drugs in 2015. FDA officials blamed several factors, including a half dozen drugs that were originally scheduled for 2016 approval received approval at the end of 2015. Also, fewer companies filed products for approval and the FDA rejected or delayed more applications than in previous years.
http://www.washingtonexaminer.com/drug-approvals-lowest-in-six-years/article/2610702

Third Wockhardt Plant Cited by FDA
India's Wockhardt has received its third warning letter from the FDA. The letter was issued Dec. 23 and stemmed from an inspection a year before at the sterile API plant in Ankleshwar, Gujarat. The plant was in trouble with the FDA because the agency had issued an import alert in August, banning both the human and animal antibiotics made at the plant. This action impacts a new antibiotic (solithromycin) awaiting approval. Investigators had noted deficiencies with Wockhardt's and Hospira's manufacturing facilities during recent inspections that need to be taken care of prior to approval of the antibiotics. The warning letter cites inadequate air handling, problems that were noted with the gowns worn by personnel conducting sterile work, as well as discovering some employees had hidden, even destroyed, test results.
http://www.fiercepharma.com/manufacturing/fda-slaps-a-third-wockhardt-plant-a-warning-letter

FDA Warning Letter to Dermatology Plant Sold by Valeant
A dermatology manufacturing plant in Laval, Quebec, that makes Premiology brand products has been issued an FDA warning letter. The agency issued a warning letter citing the dermatology product plant (1) was not adequately investigating unexplained discrepancies of any batches or components, (2) didn't even have written procedures that would ensure a quality unit would investigate batches, (3) were not validating its equipment cleaning procedures, (4) did not have written procedures for handling customer complaints, or (5) procedures for production and process control that would make sure its products met the strength, quality, and purity which they claimed to meet.
http://www.fiercepharma.com/manufacturing/fda-slaps-warning-letter-crescita-plant-sold-by-valeant

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 the FDA has banned the use of powdered surgeon gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove? They present an unreasonable and substantial risk of illness or injury.

Tip of the Week

Powdered gloves have no place in pharmacy compounding and should not be used.

Looking Back

We're widely read,
And often quoted,
But it's shaves, Not signs,
For which we're noted!
     Burma Shave