Brought to you by the International Journal of Pharmaceutical Compounding FREE TRIAL    FORMULATIONS    MY ACCOUNT 
Compounding This Week Newsletter from www.CompoundingToday.com
Our Compounding Knowledge, Your Peace of Mind
October 7, 2016  |  Volume 13  |  Issue 40
IN THIS ISSUE
 
SUBSCRIPTIONS / INFO
 
CLASSIFIEDS
 
ABOUT COMPOUNDINGTODAY
 
FREE RESOURCES
 
SUBSCRIBER RESOURCES
EXAKT 50EC+ - For Serious Compounders - EXAKTRX.com
Receive a free compounding CD with new subscription to IJPC.
New First Kits Now Available
 
Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
FDA Preemption Jurisprudence
 

IMPORTANT ARTICLE: A MUST READ FOR COMPOUNDERS

FDA to use "Preemption Jurisprudence" to take over compounding from state boards!

See the following:

http://www.fdli.org/docs/journal-articles-/brown-tomar-final-august-22.pdf?sfvrsn=0

Drugs Not to Be Compounded–Latest FDA List

� 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.

The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act:

Adenosine phosphate: All drug products containing adenosine phosphate
Adrenal cortex:All drug products containing adrenal cortex
Alatrofloxacin mesylate:All drug products containing alatrofloxacin mesylate
Aminopyrine:All drug products containing aminopyrine
Astemizole:All drug products containing astemizole
Azaribine:All drug products containing azaribine
Benoxaprofen:All drug products containing benoxaprofen
Bithionol:All drug products containing bithionol
Bromfenac sodium: All drug products containing bromfenac sodium (except ophthalmic solutions)
Butamben:All parenteral drug products containing butamben
Camphorated oil:All drug products containing camphorated oil
Carbetapentane citrate:All oral gel drug products containing carbetapentane citrate
Casein, iodinated:All drug products containing iodinated casein
Cerivastatin sodium:All drug products containing cerivastatin sodium
Chloramphenicol:All oral drug products containing chloramphenicol
Chlorhexidine gluconate:All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation
Chlormadinone acetate:All drug products containing chlormadinone acetate
Chloroform:All drug products containing chloroform
Cisapride:All drug products containing cisapride
Cobalt:All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives)
Dexfenfluraminehydrochloride:All drug products containing dexfenfluramine hydrochloride
Diamthazole dihydrochloride:All drug products containing diamthazole dihydrochloride
Dibromsalan:All drug products containing dibromsalan
Diethylstilbestrol:All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose
Dihydrostreptomycin sulfate:All drug products containing dihydrostreptomycin sulfate
Dipyrone:All drug products containing dipyrone
Encainide hydrochloride:All drug products containing encainide hydrochloride
Esmolol hydrochloride:All parenteral dosage form drug products containing esmolol hydrochloride that supply 250 milligrams/milliliter of concentrated esmolol per 10-milliliter ampule
Etretinate:All drug products containing etretinate
Fenfluramine hydrochloride:All drug products containing fenfluramine hydrochloride
Flosequinan:All drug products containing flosequinan
Gatifloxacin:All drug products containing gatifloxacin (except ophthalmic solutions)
Gelatin:All intravenous drug products containing gelatin
Glycerol, iodinated:All drug products containing iodinated glycerol
Gonadotropin, chorionic:All drug products containing chorionic gonadotropins of animal origin
Grepafloxacin:All drug products containing grepafloxacin
Mepazine:All drug products containing mepazine hydrochloride or mepazine acetate
Metabromsalan:All drug products containing metabromsalan
Methamphetamine hydrochloride:All parenteral drug products containing methamphetamine hydrochloride
Methapyrilene:All drug products containing methapyrilene
Methopholine:All drug products containing methopholine
Methoxyflurane:All drug products containing methoxyflurane
Mibefradil dihydrochloride:All drug products containing mibefradil dihydrochloride
Nitrofurazone:All drug products containing nitrofurazone (except topical drug products formulated for dermatologic application)
Nomifensine maleate:All drug products containing nomifensine maleate
Novobiocin sodium:All drug products containing novobiocin sodium
Oxyphenisatin:All drug products containing oxyphenisatin
Oxyphenisatin acetate:All drug products containing oxyphenisatin acetate
Pemoline:All drug products containing pemoline
Pergolide mesylate:All drug products containing pergolide mesylate
Phenacetin:All drug products containing phenacetin
Phenformin hydrochloride:All drug products containing phenformin hydrochloride
Phenylpropanolamine:All drug products containing phenylpropanolamine
Pipamazine:All drug products containing pipamazine
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl:All drug products containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 milligrams or more of bisacodyl delayed-release tablets
Potassium arsenite:All drug products containing potassium arsenite
Potassium chloride:All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled release dosage forms and those products formulated for preparation of solution prior to ingestion)
Povidone:All intravenous drug products containing povidone
Propoxyphene:All drug products containing propoxyphene
Rapacuronium bromide:All drug products containing rapacuronium bromide
Reserpine:All oral dosage form drug products containing more than 1 milligram of reserpine
Rofecoxib:All drug products containing rofecoxib
Sibutramine hydrochloride:All drug products containing sibutramine hydrochloride
Sparteine sulfate:All drug products containing sparteine sulfate
Sulfadimethoxine:All drug products containing sulfadimethoxine
Sulfathiazole:All drug products containing sulfathiazole (except for those formulated for vaginal use)
Suprofen:All drug products containing suprofen (except ophthalmic solutions)
Sweet spirits of nitre:All drug products containing sweet spirits of nitre
Tegaserod maleate:All drug products containing tegaserod maleate
Temafloxacin hydrochloride:All drug products containing temafloxacin hydrochloride
Terfenadine:All drug products containing terfenadine
3,3',4',5-tetrachlorosalicylanilide:All drug products containing 3,3',4',5 tetrachlorosalicylanilide
Tetracycline:All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter
Ticrynafen:All drug products containing ticrynafen
Tribromsalan:All drug products containing tribromsalan
Trichloroethane:All aerosol drug products intended for inhalation containing trichloroethane
Troglitazone:All drug products containing troglitazone
Trovafloxacin mesylate:All drug products containing trovafloxacin mesylate
Urethane:All drug products containing urethane
Valdecoxib:All drug products containing valdecoxib
Vinyl chloride:All aerosol drug products containing vinyl chloride
Zirconium:All aerosol drug products containing zirconium
Zomepirac sodium: All drug products containing zomepirac sodium

Dated: October 3, 2016.
Effective: November 2, 2016



NEW RELEASE–HAZARDOUS DRUGS LIST 2016
NIOSH has just released the 2016 List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. To download a free copy, go to:

http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf


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

India Losing Active Pharmaceutical Ingredient Market to China?
Due to the large generic drug industry in India, it has been regarded as the pharmacy of the world. However, the plan to rebuild India's bulk drug sector is under threat because support for raw material manufacturers promised by the Indian government has been slashed from $750 million to just $90 million. China's increasing API production and intermediate industry has been steadily claiming market share from Indian companies because Chinese bulk drug and intermediate imports are often cheaper than those made by India's domestic producers because they are highly subsidized by the Chinese government. Due to low profit margins on raw materials, Indian producers are being squeezed out of the market.
http://www.fiercepharma.com/pharma-asia/india-accused-backtracking-promised-support-for-beleaguered-api-sector

Ohio Doctors Not Using Site to Control Drug Abuse
A system is designed where Ohio doctors are supposed check patients' prescription histories against a state website before recommending prescription painkillers. However, an audit has found that some 12,000 physicians appear to be violating the policy aimed at stemming the opioid epidemic. A state Pharmacy Board audit identified the doctors who either weren't registered on the site or weren't using it properly. The list was turned over last week to the state Medical Board, which licenses physicians and has sent letters to all the doctors alerting them to potential violations. The total represents about one-third of Ohio physicians.
http://hosted.ap.org/dynamic/stories/U/US_PAINKILLERS_DOCTORS_OHIO?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT

 

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 today's world, it isn't just the "message/entertainment" we receive, but we now must decide the technology over which we receive it?

 

Tip of the Week

In years past, it was the desktop/transistor radios, large bulky televisions, and the large telephones setting on the desk or hanging on the wall.

Today, all these devices have melded into one in our changing world. In the not-too-distant future, we may not have smartphones, LED-televisions, etc. but simply media/entertainment earbuds/watches, holograms, etc. Oh wait, we already have the Apple Watch, ear bud devices, etc. Makes you wonder what's next!

 

Looking Back

To shaving brush,
I need not cling,
I will not hush,
Of thee I sing.
     Burma Shave

Copyright 2016
International Journal of Pharmaceutical Compounding, Inc.
122 N Bryant Ave, Edmond OK 73034
Manage my Email:
Subscribe / Un-Subscribe
Comments or Questions:
info@compoundingtoday.com
Reprints & Permissions: Reprints@ijpc.com