To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

Editorial: Quick Summary of H.R. 3204; Part I (503B)

With so many questions being asked about H.R. 3204 and how it will impact individual practices, this newsletter will present some summary points on 503A and 503B. Probably over 99% of pharmacists in independent, chain, hospital, veterinary, specialty, and other pharmacies will be under 503A so not much will change except for a few items to be discussed next week. This week we will summarize some points of 503B, Outsourcing pharmacies.

In Section 503B, an outsourcing facility is defined as a facility at one geographic location or address that:

1. is engaged in the compounding of sterile drugs.
2. has elected to register as an outsourcing facility, and
3. complies with all of the requirements of Section 503B.

Also, an outsourcing facility is not required to be a licensed pharmacy. An outsourcing facility may or may not obtain prescriptions for identified individual patients. A 'sterile drug' is one that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous form, or a drug that is required to be sterile under Federal or State law.

A facility that chooses to register with the FDA as an outsourcing pharmacy involved with sterile compounding is required to use bulk drug substances:

1. appearing on a list established by the FDA.
2. appearing on the drug shortage list in effect at the time of compounding, distribution and dispensing.
3. that comply with monographs in the USP, NF, or other compendium or pharmacopeia recognized by the FDA.
4. manufactured by an establishment that is registered with the FDA.
5. accompanied by valid certificates of analysis.

The facility must:

6. use other ingredients that comply with standards of the USP, NF, if such monograph exists, or of another compendium or pharmacopeia recognized by the FDA.
7. not use drugs that have been withdrawn or removed by the FDA because they have been found to be unsafe or ineffective.
8. not prepare drugs that are essentially copies of one or more approved drugs (except in the case of an approved drug that appears on the drug shortage list).
9. not prepare drugs that present demonstrable difficulties for compounding.
10. be in compliance with the FDA if preparing any drugs that are the subject of a risk evaluation and mitigation strategy.
11. not sell or transfer drugs to a second entity by the outsourcing facility.
12. pay all applicable fees.
13. adhere to the requirements for the label, containers, and any other required information.
14. register with the FDA between October 1 and December 31 of each year.
15. provide reports during June and December of each year to the FDA of the drugs compounded during the previous six months.
16. comply with Good Manufacturing Practices.
17. be subject to FDA inspections.
18. submit adverse event reports.

Tamiflu Oral Suspension in Short Supply Again
With the flu season here, the manufacturer of Tamiflu and some pharmacies warn that the drug is in limited or short supply. The FDA has added Tamiflu Oral Suspension to its drug shortage list, citing increased demand and temporary manufacturing delays by Genentech. No nationwide shortages have been reported for Tamiflu capsules, but some local pharmacies have had trouble getting those supplies.
http://triblive.com/news/allegheny/5375088-74/tamiflu-drug-flu#axzz2pmiau44u

Pharmacies Begin Registering with the FDA
Eleven U.S. compounding pharmacies have registered with the FDA under the new legislation to date. So far, 11 compounding pharmacies have taken up the option under the Drug Quality and Security Act of registering with the FDA, a move they hope will give them a marketing edge.

The names of the registered facilities are posted on the FDA's website and range from the larger facilities, such as Pharmedium Services, to others, including Marlborough Hospital in Massachusetts and Medi-Fare Drug and Home Health Center in Blacksburg, South Carolina. Some of the firms have already been inspected while others have yet to be inspected.
http://www.reuters.com/article/2014/01/10/us-compounding-pharmacies-fda-idUSBREA0903120140110

New Drug Approvals Decline in 2013
The FDA approved 27 first-of-a-kind drugs in 2013, down from 39 new medications in 2012, which was a 15-year high. On average, however, the FDA has approved 28 first-of-a-kind drugs annually over the past five years. The FDA says the number of drug approvals declined in 2013 mainly because there were fewer drugs submitted for review. For example, the agency received at least 32 applications for innovative medications in 2013, down from 41 in 2012. It ordinarily takes between 6 and 10 months to review new drug applications.
http://hosted.ap.org/dynamic/stories/U/US_DRUG_APPROVALS_FDA?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT

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

�that there are three kinds of men: The ones that learn by reading; the ones who learn by observation; and the rest that have to pee on the electric fence and find out for themselves?

Whatever happened to "common sense." Take time to mentor others in your sphere of influence on using common sense in daily life�there seems to be a lack of it today!

Shaving brushes,
You'll soon see 'em
On the shelf,
In some museum!
     Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

Anderson Compounding Pharmacy, Bristol, Tennessee; Mark Flanary, PharmD, mark@acprx.net. Initial Accreditation for Sterile & Nonsterile Compounding

Southern Rx LLC, d/b/a Bellevue Pharmacy of Florida, Tamarac, Florida; John Hamilton, johnh@bellevuerx.com. Initial Accreditation for Nonsterile Compounding

Pharmacy For sale
Nova-Infusion Services a fully NYS licensed Pharmacy (DEA,NYS reg.,NABP,NPI) with clean room designed for sterile compounding (and non-sterile) in central N.Y. Add this to your existing business or start up. For information contact pete@nova-infusion.com.