The Blurred Line Between "Topical" and "Transdermal", Part E

This week, we will look at some clinical implications of "topicals" and "transdermals"; formulations for different skin types and situations.

Next week we will look at "Formulation is more important than concentration."

New FDA Releases

The FDA has released four new Guidance Documents entitled:

Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)

Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products

They are available and can be downloaded at:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434270.htm

News

Drug Shortages Continue
At mid-January, more than 230 drugs appeared on the American Society of Health-System Pharmacists' drug shortage list. Most of the list is comprised of generic injectables. The peak in drug shortages occurred in 2011 when 267 agents were in short supply.
http://www.healio.com/hematology-oncology/practice-management/news/print/hemonc-today/%7B7a4d941b-ccc6-4a5a-a851-6f0727a5325f%7D/expectation-of-drug-shortages-has-become-new-norm-for-cancer-care

(Note: For the past couple of years, IJPC has been publishing formulas for drugs in short supply to aid in providing information for compounding pharmacists to meet the needs of practitioners and patients.)

Canadian Government Soon to Require Drug Shortage Notice
Soon, the Canadian government will require pharmaceutical companies to post public notices when drugs are not available, or face fines. Currently, posting notices to a website about shortages is voluntary; however, the voluntary system hasn't worked well enough.
http://uk.reuters.com/article/2015/02/10/canada-pharmaceuticals-idUKL1N0VK1NZ20150210

Hospira Recalling Multiple Lots of Ketorolac Tromethamine Injection
Hospira has announced a voluntary recall of ketorolac tromethamine injection due to a potential particulate (identified as calcium-ketorolac crystals). The lots were distributed from February 2013 to December 2014 in the U.S. Hospira is investigating the root cause and corrective and preventive actions.
http://www.fda.gov/Safety/Recalls/ucm433857.htm

Hoarding of Nicotine Lozenges
It has been reported that it is getting hard to find Nicorette lozenges. The maker of Nicorette quietly stopped making its lozenges early last year because of quality-control problems and initiated a recall; they are silent about whether it would make the lozenges again. Now, as they may disappear entirely, patients are stocking up. The recalled lozenges are described as "overly thick, overly soft, and sub and superpotent," according to the FDA. However, the lozenges were still safe to use according to the manufacturer so retailers can sell the remaining supply.
http://www.washingtonpost.com/business/economy/the-mysterious-nicotine-lozenge-that-ex-smokers-are-hoarding/2015/02/09/2b8d19c6-ae37-11e4-abe8-e1ef60ca26de_story.html

U.S. Government Withdrawing Warnings about Cholesterol
The nation's top nutrition advisory panel is dropping its caution about eating cholesterol-laden food; this following almost 40 years of government warnings about its consumption. The group has found that cholesterol in the diet need no longer be considered a "nutrient of concern"; this stands in contrast to the committee's findings five years ago, the last time it convened. The evolution of thinking among many nutritionists is that, for healthy adults, eating foods high in cholesterol may not significantly affect the level of cholesterol in the blood or increase the risk of heart disease.
http://www.washingtonpost.com/blogs/wonkblog/wp/2015/02/10/feds-poised-to-withdraw-longstanding-warnings-about-dietary-cholesterol/

Rite Aid Spends $2 Billion for PBM
The nation's third-largest drugstore chain announced that it is purchasing PBM Envision Pharmaceutical Services for about $2 billion in cash and stock. Rite Aid operates more than 4,500 stores across the U.S., and the deal, already approved by both companies' boards, is not expected to close until September. Rite Aid is following the example of rival CVS Health in integrating a PBM into a drugstore chain, Caremark Rx.
http://www.modernhealthcare.com/article/20150211/NEWS/302119953

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Did You Know ...

�that there is a difference in "entitlements" and "handouts?" Look it up!

Tip of the Week

Get involved in your profession and your government�others are, and you might not agree with what they believe in and get taken advantage of!

Looking Back

Political pull
May be of use,
For razor pull,
There's no excuse!
     Burma Shave

ACHC is pleased to announce that the following pharmacies have achieved PCAB Accreditation:

Letourneau's Pharmacy, Andover, MA; Alicia Picard, PharmD, aliciap@letourneaus.net. Initial Accreditation for Non-Sterile Compounding

Phusion Pharmacy, Coventry, RI; David Hughes, PharmD, hughes.david@phusionrx.com. Re-Accreditation for Sterile and Non-Sterile Compounding

Johnson Compounding & Wellness, Waltham, MA; John Walczyk, PharmD, RPh, john@naturalcompounder.com. Re-Accreditation for Sterile and Non-Sterile Compounding

Villa Pharmacy, Winter Haven, FL; Robert Bliss, PharmD, villapharmacy@yahoo.com. Initial Accreditation for Non-Sterile Compounding