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LOOKING FORWARD!
Two weeks from today, we will begin an extended series looking at the FDA 483 observations issued to several pharmacies (which will be unnamed). A list of these observations has been compiled, and this newsletter will address them along with any documentation, or lack thereof, of standards, laws, and/or regulations for the observations. This newsletter will attempt to describe which observations are factual, and which are simply opinion.

Editorial: Current Good Manufacturing Practices (cGMP) Regulations, Part 12

This week, we will continue our summary review of Good Manufacturing Practices by looking at a portion of Subpart J-Records and Reports (Sections 211.180 through 211.186). Next week, we will continue Subpart J and also discuss Subpart K-Returned and Salvaged Drug Products as we complete this series. The following are the subpart sections and a brief description of their content.

Subpart J—Records and Reports

Sec. 211.180 General Requirements
Generally, records on production, control, or distribution associated with a batch shall be retained for at least one year after the expiration date of the batch; for certain exempt OTC drug products lacking expiration dating, records must be kept for 3 years after distribution of the batch. These records must be maintained for all components, containers, closures, and labeling and be available for authorized inspection during the retention period at the establishment where the activities occurred. These records may be the original or true copies, including photocopies, microfilm, microfiche, or other accurate reproductions of the original records; suitable readers must be available.

These written records shall be maintained so they can be evaluated, at least annually, for the quality standards to determine the need for any changes in the drugs' specifications or manufacturing or control procedures. Written procedures are required and must be followed for a review of a representative number of batches, complaints, recalls, returned or salvaged drug products, and investigations conducted under 211.192 for each drug product. Also, procedures must be established to assure that the responsible officials of the firm are immediately aware of any actions and are notified in writing of any investigations conducted under 211.198, 211.204, or 211.208 of these regulations; any recalls, reports of inspectional observations issued by the FDA; or any regulatory actions related to GMPs brought by the FDA.

Sec. 211.182 Equipment Cleaning and Use Log
Written records of major equipment cleaning, maintenance (except routine lubrication, adjustments, etc.), and use shall be included in individual equipment logs and, for dedicated equipment, the batch records.

Sec. 211.184 Component, Drug Product Container, Closure, and Labeling Records
Records shall include the identity and quantity of each shipment of each lot of components, containers, closures, labeling, name of the supplier, supplier's lot number(s), receiving code as specified in 211.80, and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known; also, the results of any test or examination and the conclusions. In addition, an individual inventory record of each component, container, and closure for each component and a reconciliation of the use of each lot of such component. The examination and review of labels and labeling for conformity with established specifications shall be documented. The disposition of rejected components, containers, closures, and labeling shall be documented.

Sec. 211.186 Master Production and Control Records
Master production and control records for each drug product shall be prepared, dated, and signed by one person and independently checked, dated, and signed by a second person. The preparation of this record shall be described in a written procedure and the procedure must be followed. The master production and control records shall include:

• Name and strength of the product and a description of the dosage form
• Name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure in the drug product and a statement of the total weight or measure of any dosage unit
• List of components designated by names or codes
• Accurate statement of the weight or measure of each component. Reasonable variations may be permitted provided they are justified in the master production and control records.
• Statement concerning any calculated excess of component
• Statement of theoretical weight or measure at each appropriate phase of processing
• Statement of theoretical yield, including maximum and minimum percentages allowed
• Description of containers, closures, packaging materials, including specimen/copy of labels, and other labeling signed and dated by the person(s) responsible for approval of such labeling
• Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions

FDA Admits to Lack of Aggressive Response in NECC Situation
The FDA chief conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center of a deadly meningitis outbreak. FDA Commissioner Margaret Hamburg said a confusing legal landscape, combined with resistance from compounding pharmacies, had hampered her agency's ability to act on a myriad of complaints against the New England Compounding Center and its sister company, Ameridose LLC. "I wish we had acted earlier," Hamburg told a House Energy and Commerce subcommittee looking into the outbreak, which has killed 53 people and sickened more than 700. This was the second hearing held by the committee to determine whether the FDA could have prevented the outbreak and whether it needs greater powers to regulate pharmacies that compound drugs tailored for specific patients.
http://www.reuters.com/article/2013/04/16/us-usa-health-meningitis-idUSBRE93F1FW20130416

Acorda's Ampyra Shows Improvement in Multiple Sclerosis Patients
Acorda Therapeutics Inc., maker of the drug Ampyra (Dalfampridine, 4-aminopyridine, Ampyra, Fampridine) to improve walking in multiple sclerosis (MS) patients, rose to its highest value in more than two years after the company said a small study showed the medicine also helped people who have had strokes. Ampyra, approved in 2010 for use in MS, showed a "significant improvement" in walking speed over 25 feet among stroke patients, Chief Executive Officer Ron Cohen said in a telephone interview. Based on the results, the Ardsley, New York-based company plans to proceed with further studies.
http://www.businessweek.com/news/2013-04-15/acorda-s-ampyra-improves-walking-in-stroke-patients

[Note: This is the same drug that was recommended to the FDA committee to be placed on the "Bulks List" during the FDAMA97 implementation hearings. The Company requested that it not be approved for compounding so they could get sufficient patients enrolled in their clinical studies, and they would supply the compounders' patients with the drug. A few weeks later, they backed out of their promise, but the FDA would not allow it to be reconsidered by the committee for the Bulks List. Today, 15 years later, they are still reporting the results of a "small, Phase II proof-of-concept trial" and many patients have been denied their drug.]

Fraudulent Research on FDA-approved Drugs Stay on the Market
Key Points:

• In 2011, the FDA announced that years' worth of studies from a major drug research lab were discovered to be potentially worthless.
• About 100 drugs were on the U.S. market based in part on these studies.
• The FDA allowed the drugs stay on the market with no new testing (in some cases until now).
• As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market.
• The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed.
• The FDA has never named the drugs, saying to do so would reveal trade secrets.

Instead, the agency decided to handle the matter quietly with virtually no public disclosure of what it had discovered. None of the drugs were pulled from the market, even temporarily, while not knowing for sure they were safe and effective. To this day, some drugs remain on the market despite the FDA having no additional scientific evidence to back up the safety and efficacy of these drugs. By contrast, the European Medicines Agency, has pulled seven Cetero-tested medicines from the market.
http://www.propublica.org/article/fda-let-drugs-approved-on-fraudulent-research-stay-on-the-market

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Peripheral Brain for the Pharmacist
3rd Edition
American Pharmacist Association
35 laminated cards (4"� 7.25" hole-punched with metal ring); March 2013; $15.95

This card set contains 35 laminated cards containing key clinical information frequently used by pharmacists. They are color-tabbed to enhance ease of obtaining information along with a patient monitoring card that can be photocopied. The cards contain pediatric dosages of common nonprescription drugs, warfarin management, normal values for common lab tests, BMI, IBW, and BSA equations, along with conversions and weights and measures. In addition, guidelines for hypertension, diabetes, cholesterol, asthma, pneumonia, etc., as well as target serum concentrations for selected drugs, and many, many more items. These cards easily slip into a pharmacy jacket pocket for ease and convenience of use.

�that a blind person asked St. Anthony: "Can there be anything worse than losing eye sight?" He replied: "Yes, losing your vision!"

Today, too many depend upon the "vision" of others and copy their select attributes and behaviors. Pharmaceutical compounding is experiencing some difficult times due to the ignorance, selfishness, and self-centeredness of a few. Despite that, we must retain our vision of "quality compounding" to serve patients and prescribers and the healthcare needs of the nation.

Hardly a driver
Is now alive,
Who passed on hills
At 75!
      Burma Shave

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

Thrifty Health & Compounding Pharmacy, Humble, Texas. Terry Mielke, RPh, thriftypharm1@embarqmail.com. Re-accreditation for Nonsterile Compounding

Westlab Pharmacy, Gainesville, Florida. Prince Hinson, RPh, info@westlabpharmacy.com. Initial Accreditation for Sterile and Nonsterile Compounding

Premier Pharmacy Labs, Inc., Weeki Wachee, Florida. Hector Medrano, PharmD, hectormrph@tampabay.rr.com. Re-accreditation for Sterile and Nonsterile Compounding