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Editorial: Difficult to Compound, Part II

The first PCAC approved the factors presented in last week's newsletter regarding the development of the "difficult to compound" list. In addition, they suggested that stability should be considered within those seven factors.

The dosage forms recommended, after discussion, for the difficult to compound list included the following:

• Metered dose inhalers
• Dry powdered inhalers
• Transdermal drug systems (commonly called patches)

• There was an extended discussion on whether or not to include "sterile drug products" on the list if they are not compounded in accordance with USP Chapter <1206>. The committee was in favor of using a MODIFIED USP Chapter 1206. (Editor's Note: Since <1206> is an "informational chapter," it was extensively revised and renumbered as <797> by the USP.)
• The PCAC approved the following as potentially demonstrably difficult to compound:
  • Sustained release capsule/tablets/suspensions; enteric-coated products
  • Antibiotics for pediatric use with flavoring agents added
  • Biotech products covered under 505
  (Editor's Note: Of this last group, the sustained release capsules/tablets/suspensions were implemented.)

Next week, we will continue our discussion on the first PCAC activities.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

"New" Drug Shortages Reduced but Over 300 Still Remain on the List
"New" U.S. drug shortages caused by manufacturing issues, manufacturer closures, recalls, and quality issues have been reduced since 2012 but still remain at about 300 drugs remaining in long-term shortage. This costs U.S. hospitals about $200 million a year. The shortage delayed or canceled patient care in 65% of hospitals, compared with 84% in 2011.
http://www.bloomberg.com/news/2014-02-27/drug-shortages-reduced-in-u-s-while-disruptions-remain.html

FDA Generic Failures Cause the FDA to Step Up Action
The FDA has banned four Indian plants from selling drugs in the U.S. over the past nine months and says it is increasing the inspections it will undertake there. Mylan's CEO says "It'll get worse before it gets better." Mylan has half of its more than 20,000 employees in India. She stated in an interview that consumers will see "more market disruption, more companies being shut down, more bans on facilities," and that "I'd be shocked if there's not."
http://www.bloomberg.com/news/2014-02-28/generic-drug-failures-spur-concern-as-fda-steps-up-action.html

Avastin and Lucentis in Italy
Italy's antitrust regulator fined Novartis AG and Roche Holding AG $251 million for allegedly colluding to prevent the use of Roche's Avastin cancer drug as a treatment for age-related macular degeneration in favor of a more expensive drug, Lucentis, that the two companies market jointly.
http://www.bloomberg.com/news/2014-03-05/italy-fines-novartis-roche-251-million-over-eye-drug.html

Do Drug Benefit Managers Reduce Health Costs?
While cutting goes on in health care, one of the biggest and least understood players is getting bigger and richer, the Pharmacy Benefit Managers (PBMs), which include CVS Caremark and Express Scripts. The roles of PBMs have expanded from simply handling prescription billing about 15 years ago to deciding which drugs insurers cover, what they cost, and how much pharmacies are reimbursed for them. However, some state lawmakers are trying to rein them in as legislation is active in 14 states that would require more pricing disclosure by these companies.
http://www.usatoday.com/story/money/personalfinance/2014/03/03/pharmacy-benefit-managers-healthcare-costs-savings/5495317/

USV Indian Plant Receives FDA Warning
Pointing out data integrity-related issues, the FDA asked the company's consultant to identify and interview current and former employees who might have been responsible for inaccurate data reporting. The warning letter highlighted the "lack of reliability and accuracy of data generated" by the firm.
http://www.business-standard.com/article/companies/us-fda-warning-to-usv-worries-industry-114030500014_1.html

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�that when you hear someone say "The fact of the matter is�," what they really mean is "My opinion on the matter is�"? This is especially evident when the same facts are presented by two sides differently to convince you to agree with their individual "opinion."

To the politicians: We can look at the same facts that you are looking at! Tell us upfront that you are stating your opinion! Otherwise, you don't look very truthful. Please just say, "My opinion on the matter is�"! We can then decide!

It's not toasted,
It's not dated,
But look out-
It's imitated!
Insist on:
     Burma Shave

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

B&J Pharmacy, San Marcos, Texas; Rebecca Cable, marketing@hillcountryrx.com. Initial Accreditation for Nonsterile Compounding

Philly Pharmacy Inc., DBA Medicine Shoppe 0635, New Philadelphia, Ohio; Brad White, RPh, bradley@bradleywhite.com. Re-Accreditation for Nonsterile Compounding

Surgery Pharmacy Services, Inc., Chattanooga, Tennessee; Timothy Glascock, PharmD, surgerypharmacy@gmail.com. Initial Accreditation for Sterile Compounding

Essential Pharmacy Compounding, Omaha, Nebraska; Kris Shubert, PharmD, kshubert@kohlls.com. Re-Accreditation for Sterile & Nonsterile Compounding

Lone Oak Pharmacy & Compounding Shoppe, Paducah, Kentucky; Michelle Lowe, RPh, mlowe@loneoakpharmacy.com. Initial Accreditation for Nonsterile Compounding

Institutional Pharmacy Solutions, Irwindale, California; Tommy Phan, PharmD, tphan@ipspharmacy.com. Initial Accreditation for Nonsterile Compounding