Please note that these Draft Guidances are NOT FINALIZED; when they become finalized, they will represent the current thinking of the FDA on the specific topics. Copies can be obtained free of charge at the URL listed below. The complete list of final and draft guidances for both 503A and 503B facilities is available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm452240.htm

Summary: This guidance presents FDA's policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 3512 of the PHS Act when such activities are not within the scope of the product's approved biologics license application as described in the approved labeling for the product.

For this Draft Guidance, the following definitions are used:

Mixing means combining an FDA-licensed biological product with one or more ingredients. It does not include activities at the point of care for immediate administration to a single patient after receipt of a patient specific prescription, etc.

Repackaging means taking a licensed biological product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the product.

Also, this guidance does not apply to blood and blood components for transfusion, vaccines, cell therapy products, and gene therapy products.

This Draft Guidance is divided into the following sections:

1. Introduction and Scope
2. Background
   1. Biological Products
   2. Legal Framework for FDA's Regulation of Biological Products
   3. Sections 503A and 503B of the FD&C Act Do Not Exempt Biological Products from the Premarket Approval Requirements of the PHS Act or from Provisions of the FD&C Act.
   4. Hospital and Health System Repackaging of Drugs In Shortage For Use in the Health System (Section 506F of the FD&C Act)
3. Policy
   1. General Conditions
   2. Mixing, Diluting, or Repackaging Licensed Biological Products.
   3. Licensed Allergenic Extracts

• Appendix I
  • Microbial Challenge Study Design

In Section I, there are many items listed that the guidance is not intended to address.

In Section II, Item D, there is an explanation of the FDA Safety and Innovation Act (FDASIA) of 2012 exempting certain hospitals within a health system under certain conditions.

In Section III, there is a long list of conditions under which the FDA does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not in their approved labeling.

Next week, we will look at the Draft Guidance, "Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act".
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM496286.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 Authorities Report 27 Drugs Failing Quality Tests from Leading Firms
18 drug companies have been accused by Indian drug regulators in seven states of selling substandard products after quality tests identified a range of product issues ranging from deceptive labeling to inappropriate quantities of active ingredients. The companies included Abbott India, GSK India, Sun Pharma, Cipla, Wockhardt Pharma, and Glenmark Pharma. Twenty-seven products failed to meet quality standards.
http://www.fdanews.com/articles/179505-indian-state-authorities-report-27-drugs-from-leading-firms-failed-quality-tests

Health Spending in U.S. in 2015 Averaged Nearly $10,000 Per Person
Total spending on health care in the U.S. increased during 2015 at the fastest rate since the 2008 recession, reaching $3.2 trillion, or an average of nearly $10,000 a person, DHHS reported. Federal healthcare spending increased by 21 percent over the past two years. Over all, health spending accounted for 17.8 percent of the nation's economy in 2015, up from 17.4 percent in 2014. Some contributors are the following:

• Strong growth in new specialty medications such as those used to treat hepatitis C, cancer, autoimmune diseases, and multiple sclerosis.
• Prices for existing brand-name drugs increased at a double-digit rate for the fourth consecutive year.
• Retail spending on prescription drugs grew 9 percent last year-more than any other category of healthcare goods and services-and reached $324.6 billion, representing 10 percent of all health spending.

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Did You Know ...

�that it seems like times are changing? I know you have heard this many times, but "a rubber band can only be stretched so far before it either snaps or regains its relaxed structure."

Tip of the Week

Pharmacy's rubber band has been in the process of being stretched for decades. Promises of change in the profession have been in the works since the 1960s, over 50 years ago. The primary role of pharmacists appears to still be the provision of drug products (manufactured or compounded) and drug information about the products. During my college days in the 1960s, we were told we would no longer be practicing in stores with cards, candy, and cosmetics, etc., but would only be counseling on drug therapy and not be dispensing drugs any longer; we would be in an "office-based practice." Well, 50 years later, the majority of pharmacist's are still dispensing drugs (manufactured and compounding) and drug information. Changes adversely impacting pharmacy and patient care are often related to PBMs, insurance companies, imbalance in pharmaceutical education, and even PHARMA companies. We have lost a lot of our former independence and are being over-regulated, which is stifling our practices. Something needs to change before our rubber band either breaks or re-establishes our scientific and professional structure and practice.

Looking Back

Shaving brush,
And soapy smear,
Went out of style,
With hoops my dear!
     Burma Shave