Compounding This Week Newsletter from www.CompoundingToday.com
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May 17, 2013 Volume 10, Issue 20
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Compounders on Capitol Hill - June 1-4 2013 - www.iacprx.org/cch
 
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor

Editorial: Documentation vs Opinion on Compounding Regulatory Activities III

This continues the series looking at some of the 483 observations and Board of Pharmacy activities and tries to provide documentation surrounding these specific activities. Comments are based upon complying with state board of pharmacy laws and regulations and United States Pharmacopeia (USP) standards.

Observation: Sterility testing is not routinely performed at the end of shelf-life or at the end of stability studies.

USP Standards:

General Notices 10.40.100.1 Compounded Preparations

"The label on the container or package of an official compounded preparation shall bear a beyond-use date [BUD]. The beyond-use date is the date after which a compounded preparation is not to be used. Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products."

U.S. Food and Drug Administration (FDA) Guides:

FDA Inspection Technical Guide
Expiration Dating and Stability Testing for Human Drug Products

10. Sterility Testing
Products manufactured as sterile must maintain that quality throughout the labeled expiration dating period as long as the product is unopened and stored according to labeled instructions. The ability of the product to retain its sterile condition is a function of the container-closure system. When qualifying the container-closure system, sterility testing should be performed initially and at the end of the expiration dating period. Once any particular container-closure system can be demonstrated to maintain sterility throughout the expiration dating period, it is unnecessary to revalidate its ability to maintain sterility for other ingredients that may be placed into the same container-closure system."

Comments:

The USP General Notices plainly state that compounded preparations must contain a BUD and this BUD can be determined differently than the procedures required by the FDA for establishing expiration dates. Expiration dates are applied to manufactured products with an expected shelf life of about 2 to 3 years. BUDs are for up to 6 months but generally much shorter than that. The requirement from the FDA for a sterility test at the end of the expiration period is for documenting that a container-closure system maintains sterility. There is nothing in <795> or <797> stating that sterility testing at the end of the BUD is required.

The only mention in <797> of a follow-up sterility test is in the case of Redispensed compounded sterile preparations (CSPs) where it states "Assignment of new storage times and BUDs that exceed the original dates for returned CSPs is permitted only when there is supporting evidence from sterility testing and quantitative assay of ingredients."

As a general rule for CSPs, after sterility is addressed, BUDs are based upon physical and chemical stability.

Also, in the majority of CSPs, there will be nothing left to analyze as only a minimum number of preparations to meet the needs are compounded and dispensed/administered.

Summary:

This is another example of the improper use of Good Manufacturing Practices (GMPs) inspection guidelines for inspecting a pharmacy that is subject to Good Compounding Practices, not GMPs. The costs to pharmacies in responding to these inspections are generally in the tens of thousands of dollars�or more! That is a lot of money for a small business.


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

 
News

Senate Close to Finalizing Proposed Drug Compounding Bill
The U.S. Senate appears close to finalizing a bill that would require pharmacies that compound and sell sterile drugs across state lines to submit to greater federal regulation. Under the proposed law, compounding pharmacies that make sterile preparations/products and distribute them across state lines would be known as "compounding manufacturers" and be regulated by the FDA and not be licensed as pharmacies, which are regulated by states.

Under the proposed bill, the FDA would have the power to access the records of compounding manufacturers but would not have access to records of traditional compounding pharmacies. It would also exempt compounding manufacturers from the strict regulatory oversight that governs traditional manufacturers.
http://www.reuters.com/article/2013/05/09/usa-health-meningitis-hearing-idUSL2N0DQ3E420130509

Doctors Still Reject Medicaid
Fewer than half of U.S. doctors and other healthcare professionals accept Medicaid patients because of low payments, according to a recent study. For those that do accept Medicaid patients, getting an appointment sometimes can take months because of the high demand. The situation is worse in rural areas and 77% of the nation's 2,000-plus rural counties are designated as health professional shortage areas, according to the National Conference of State Legislatures. The lack of doctors is a growing problem nationwide that will only worsen as some 27 million people get health coverage by 2016 as part of the Patient Protection and Affordable Care Act. The Association of American Medical Colleges projects a shortage of 29,800 primary care doctors and 33,000 specialty doctors in 2015 alone.
http://www.mcclatchydc.com/2013/05/13/191105/most-doctors-still-reject-medicaid.html#.UZOwQUMo7-c

Ranbaxy Pleads Guilty in Federal Case
Ranbaxy pleaded guilty to federal drug safety violations and will pay $500 million in fines to resolve claims that it sold inferior drugs and made false statements to the FDA about its manufacturing practices at two factories in India. The settlement is the largest in history involving a generic manufacturer and drug safety.
http://www.nytimes.com/2013/05/14/business/global/ranbaxy-in-500-million-settlement-of-generic-drug-case.html?emc=tnt&tntemail0=y&_r=1&

 
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Book Review

Remington: An Introduction to Pharmacy
Allen LV Jr., Editor
Pharmaceutical Press; Paperback; 672 pages; $49.95

There has been a long-time need for a book that introduces the first-year pharmacy student to all the different aspects of pharmacy and one that would serve as an introduction to the content and importance of courses involved in the making of a pharmacist.

The content is hand-picked from Remington: The Science and Practice of Pharmacy, with entire sections condensed to a single chapter. It contains contributions from over 220 leading international experts and a vast coverage that can be relied upon. With this very valuable resource used as an early-on introduction, pharmacy students should be able to confirm their career choice early in their curriculum.

 
Did You Know ...

...that Armed Forces Day is celebrated this Sunday, May 18th? It was first observed on May 20, 1950; the day was created on August 31, 1949 to honor Americans serving in the five U.S. military branches—the U.S. Army, U.S. Navy, U.S. Marine Corps, U.S. Air Force, and U.S. Coast Guard—following the consolidation of the military services in the U.S. Department of Defense. Because of their unique training schedules, National Guard and Reserve units may celebrate Armed Forces Day/Week over any period in the month of May.

 
Tip of the Week

Take time to honor those who have served our country!

 
Looking Back

When you drive,
If caution ceases,
You are apt,
To rest in pieces!
      Burma Shave

 
Classifieds

PCCA Junior V-Blender for sale - hardly used and in perfect shape. 500ml V-Cylinder mixes up to 200ml Touchpad controls rotation, speed, and inversion times. $2500. Call Sharon @ 310-395-3294.

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