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

As we presented last week, there are differences and overlaps in the use of the terms "topical" and "transdermal." Those differences and overlaps generally involve the way the terms are used, especially the term "topical."

"Topical" can be used in much the same manner as "oral," "parenteral," "inhalation," etc., where the general Route of Administration is intended, as described in USP <1151> Pharmaceutical Dosage Forms. This would be the "Tier One: Route of Administration" level in Figure 1: Compendial Taxonomy for Pharmaceutical Dosage Forms.

"Topical" and "transdermal" can be considered as subcategories of "Topical Route of Administration" at the level of "Tier Two: Dosage Form and Physical Properties" and refer to the "extent, if any, of absorption" of the active drug. To complete the Taxonomy, the remaining levels are "Tier Three: Type of Release Pattern" and "Tier Four: Comprehensive Testing Strategy." Our emphasis here will be on the intended site of action of the contained drug. Non-drug (no API) containing "Topicals" would generally be for emollient, hydrating effects, and would usually be "topical."

A "Topical" drug (API) dosage form would be one that is designed to deliver the drug into the skin in treating skin disorders where the skin is the target organ.

A "Transdermal" drug (API) dosage form would be one that is designed to deliver drugs through the skin (percutaneous absorption) to the general circulation for systemic effects. In this case, the skin is NOT the target organ but merely the route the drug must pass to reach the circulatory system.

As these have direct clinical implications, next week we will look at the composition of these dosage forms.

News

Bill to Allow Imported Medicines from Canada Introduced
In the latest bid to lower prescription drug costs, two U.S. Senators have re-introduced legislation that would allow Americans to purchase medicines from Canada. This bill would permit Americans with a valid prescription from a physician licensed in the U.S. to order up to a 90-day supply of medicines from a licensed Canadian pharmacy. Prescription drugs would have to have the same active ingredients, dosage forms, and potencies as medicines that are approved by the FDA. In order to be approved for this, the Canadian pharmacy must have been in existence for at least five years. The drugs come with the same safety standards and are the same dosages sold in the U.S, but, currently, law prevents Americans from importing them and benefiting from the savings. Only one state has enacted similar legislation; Maine began allowing its residents to purchase prescription drugs from some pharmacies in the U.K., Canada, New Zealand, and Australia. The law has been supported by the business community, but has come under attack by the pharmaceutical industry.
http://blogs.wsj.com/canadarealtime/2015/01/09/senators-re-introduce-bill-to-allow-imported-medicines-from-canada/

China to Allow Online Sales of Prescription Drugs
China will allow online sales of prescription drugs as early as this month. This policy will open up an over $161 billion market to online pharmacy operators like Alibaba Group Holding Ltd. and Wal-Mart Stores Inc. The China Food and Drug Administration (CFDA) is finalizing which prescription medicines will be approved for sale.
http://uk.reuters.com/article/2015/01/09/china-pharmaceuticals-idUKL3N0UE1WK20150109

FDA Inspectors in India to be Accompanied by Officials
Many Indian pharma companies have faced regulatory action by the U.S. FDA in the recent past for alleged violation of GMPs. The Indian government has requested that the U.S. FDA allow its officials to be present during inspections of domestic pharma units. Some of these companies have been barred from selling their drugs in the U.S. and other countries. The FDA formerly informed the officials when they were coming, but, now, they started coming without any notice. A number of companies, including Ranbaxy, Sun Pharma, IPCA Labs, Wockhardt, and Dr Reddy's Laboratories have been cited.
http://www.business-standard.com/article/pti-stories/india-wants-its-officials-during-fda-inspections-at-drug-units-115011100123_1.html

New Division Launched at FDA—The Office of Pharmaceutical Quality
The U.S. FDA has launched an initiative aimed at reducing lapses in quality control at pharmaceutical manufacturing facilities. The project, some 10 years in the making, is designed to establish consistent quality standards for all drugs, whether brand name or generic. The Agency has established the Office of Pharmaceutical Quality that will be responsible for some 10,000 decisions a year.

The average annual number of recalled units between 2010 and 2012 was 225 million. The number between 2013 and 2014 was roughly 70 million units. The FDA banned numerous generic drugs from India, citing quality-control problems ranging from data manipulation to sanitation. India supplies roughly 40% of generic and over-the-counter drugs used in the U.S. Brand-name drug companies are not immune either. Johnson & Johnson, for example, has been forced to recall dozens of products over the past few years, ranging from artificial hips to children's Tylenol.
http://www.reuters.com/article/2015/01/12/us-usa-fda-qualitycontrol-idUSKBN0KL2EI20150112

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Did You Know ...

�that there are a lot of "Chicken Little's" out there�but is the sky really falling?

Tip of the Week

Mark Twain was quoted as saying, "I have known a great many troubles, but most of them never happened"! It seems we are intent on "straining at a gnat and swallowing a camel!" Wonder where that leads????

Looking Back

Eeny-meeny,
Miny-mo.
Save your skin,
Your time, Your dough!
     Burma Shave

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

Allcare Pharmacy, Lyons, Georgia; Brian Rickard, PharmD, rickard.brian@gmail.com. Initial Accreditation for Nonsterile Compounding

MediStat Rx, LLC, Foley, Alabama; Lucy Hazebrook, RPh, lucy@medistat.com. Initial Accreditation for Sterile & Nonsterile Compounding

Scotts Pharmacy, Macon, Georgia; Bryan W. Scott, PharmD, bryanscott03@gmail.com. Re-Accreditation for Sterile & Nonsterile Compounding

WELLHealth Rx, Jacksonville, Florida; Rakesh Patel, RPh, rakesh.patel@wellhealthrx.com. Re-Accreditation for Sterile & Nonsterile Compounding

Michael's Pharmacy, Abingdon, Virginia; Michael Johnson, RPh, michaelspharmacy@bvu.net. Initial Accreditation for Nonsterile Compounding

Don's Pharmacy, Reno, Nevada; David Vasenden, RPh, david@donspharmacy.com. Re-Accreditation for Nonsterile Compounding

Fallon Wellness Pharmacy Saratoga, Saratoga Springs, New York; Michael Lenz, RPh, fallonpharmacysaratoga@gmail.com. Re-Accreditation for Nonsterile Compounding

Magnolia Specialty Pharmacy, Hattiesburg, Mississippi; April Malone, PharmD, aprilmccoy@hotmail.com. Initial Accreditation for Nonsterile Compounding

Harrold's Pharmacy, Wilkes Barre, Pennsylvania; Julie Winsock, PharmD, bears1999@aol.com. Initial Accreditation for Sterile & Nonsterile Compounding

Loop Pharmacy & Home Medical, Saint Albans, West Virginia; Erin Rudge, RPh, erinrudge@looppharmacy.com. Re-Accreditation for Sterile & Nonsterile Compounding

Hill Country Apothecary, Lakeway, Texas; Omar Gonzalez, PharmD, omarcgonzalez@gmail.com. Initial Accreditation for Nonsterile Compounding

Las Colinas Pharmacy, Irving, Texas; Karen Moody, PharmD, lascolinaspharmacy@gmail.com. Initial Accreditation for Sterile & Nonsterile Compounding

Heritage Compounding Pharmacy, Mobile, Alabama; Sara Nolan, PharmD, Sara@heritagecompound.com. Initial Accreditation for Nonsterile Compounding

University Compounding Pharmacy, Troy, Michigan; Bradley McCloskey, PharmD, brad@univrx.com. Initial Accreditation for Sterile & Nonsterile Compounding

Custom Prescriptions, Bellevue, Washington; Craig Toman, PharmD, drcraigtoman@gmail.com. Re-Accreditation for Sterile & Nonsterile Compounding

Wedgewood Pharmacy, Swedesboro, New Jersey; Daniel Bitler, dbitler@wedgewoodpharmacy.com. Re-Accreditation for Sterile & Nonsterile Compounding

Central Drugs, Fullerton, California; Nayan Patel, PharmD, nayan@anypharmacy.com. Initial Accreditation for Nonsterile Compounding

Pyramids Pharmacy Webster, Webster, Texas; Mohamed Kaseb, rx2@pyramidspharmacy.com. Initial Accreditation for Nonsterile Compounding

Pyramids Pharmacy, Houston, Texas; Mohamed Kaseb, rx@pyramidspharmacy.com. Initial Accreditation for Nonsterile Compounding