Beware of drug transfer dealers that are not California-licensed Wholesalers

The following warning appeared in the March 2012 California Board of Pharmacy Newsletter:

Frequently, pharmacies find themselves with near-expired
drugs, partially full containers of drugs, and drugs that are
rarely dispensed and unlikely to be dispensed in the near
future. The pharmacies may return such drugs to the wholesaler
they purchased them from or to a reverse distributor, and less
frequently to the manufacturer itself. Sometimes a pharmacy may
be partially reimbursed for the cost of the drugs or charged a fee
for destroying the drugs.
Some California pharmacies, seeking to reduce their
inventory of such drugs have become involved with out-of-state
companies who solicit membership in their online business,
which allows members to post their requests to buy, sell, bid on,
or trade unwanted drugs to other members. One such company
assures that becoming a member and using their services will
increase the pharmacies’ profits by 50 percent. However, all
the parties to such transactions may be violating

Rule Regarding Patient-Centered Labels for Prescription Drugs Now in Effect in California

The new rule in California provides:


1707.5. Patient-Centered Labels for Prescription Drug
Containers; Requirements
(a) Labels on drug containers dispensed to patients in California
shall conform to the following format:
(1) Each of the following items shall be clustered into one
area of the label that comprises at least 50 percent of the
label. Each item shall be printed in at least a 10-point
sans serif typeface or, if requested by the consumer, at
least a 12-pooint typeface, and listed in the following
order:
(A) Name of the patient
(B) Name of the drug and strength of the drug. For the
purposes of this section, “name of the drug” means
either the manufacturer’s trade name of the drug, or
the generic name and the name of the manufacturer.
(C) The directions for the use of the drug.
(D) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated
on the prescription.
(2) For added emphasis, the label shall also highlight in
bold typeface or color, or use blank space to set off the
items listed in subdivision (a)(1).
(3) The remaining required elements for the label specified
in section 4076 of the Business and Professions Code,
as well as any other items of information appearing on
the label or the container, shall be printed so as not to
interfere with the legibility or emphasis of the primary
elements specified in paragraph (1) of subdivision (a).
These additional elements may appear in any style, font,
and size typeface.

To read remainder of new rule, click here.

Alabama Board of Pharmacy to Discuss Compounding Rules at July Meeting

OPEN WORK SESSION AGENDA:

Wednesday, July 18^th at 7:30 AM

• Topics to include the following:
• Call center rules for Act 2012-213 (Walgreens)

Thursday, July 19^th at 8:00 AM

(will likely last all day)

• Complete call center rules for Act 2012-213 if needed
• Compounding Rules

Agenda can be found here.

What Happened to James Belden, DVM, in the Franck's case

Pursuant to the June 7, 2011, Florida Board of Veterinary Medicine the following occurred:

BOARD OF VETERINARY MEDICINE

General Business Meeting

June 7, 2011

Page 1

MINUTES

Board of Veterinary Medicine

General Business Meeting

Holiday Inn Resort – The Castle

8629 International Drive

Orlando, FL 32819

June 7, 2011

James Belden, DVM: Case number 2009-021573

Dr. Belden was present at the meeting and was represented by counsel, Daniel Bachi. Dr. Belden was sworn in by the court reporter.

Ms. Lewis was recused due to her participation on the probable cause panel.

Ms. Henderson presented the case as a settlement stipulation. Ms. Henderson advised the board the administrative complaint alleges the Respondent administered Stanzolol and Butorphanol without adhering to statutory record keeping requirements. Ms. Henderson advised the board the department recommended a fifteen hundred dollar ($1,500.00) fine, one thousand nine hundred and sixty two dollars and eighty five cents ($1,962.85) in costs and six (6) months probation.

After discussion by the board the following motion was made.

MOTION: Dr. Maxwell made a motion to accept the settlement stipulation as presented.

SECOND: Dr. Helm seconded the motion and the motion passed unanimously.

Utah Rules Relating to Compounding

The Pharmacy Practice Act Rule (Rule R156-17b) in Utah that are in effect as of June 1, 2012, relating to Pharmacies and Compounding can be found here.

Texas State Board of Pharmacy Proposed Amendments

SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.131, §291.133
The Texas State Board of Pharmacy proposes amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations, and §291.133, concerning Pharmacies Compounding Sterile Preparations. The proposed amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rules are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rules.
Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure that the proper recall procedures are being practiced by pharmacies that are compounding sterile and non-sterile preparations. There is no fiscal impact for individuals, small or large businesses, or to other entities which are required to comply with these sections.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8008. Comments must be received by 5:00 p.m., July 31, 2012.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.131.Pharmacies Compounding Non-Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (6) (No change.)
(7) Drugs, components, and materials used in non-sterile compounding.
(A) - (H) (No change.)
(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.
(8) - (10) (No change.)
(e) - (f) (No change.)
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.
(3) If the pharmacy identifies a potential or confirmed harm to a patient, the pharmacist-in-charge shall ensure that:
(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.
[(1) The pharmacy shall have written procedure for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or to a pharmacy for administration. The recall procedures shall require:]
[(A) notification to each practitioner, facility, and/or pharmacy to which the preparation was distributed;]
[(B) notification to each patient to whom the preparation was dispensed;]
[(C) quarantine of the product if there is a suspicion of harm to a patient; and]
[(D) a recall if there is probable or confirmed harm to a patient.]
[(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm to a patient, the pharmacy shall immediately notify and provide information as required by the board to the following:]
[(A) the Texas Department of State Health Services, Drugs and Medical Devices Group, if the preparation is distributed for office use; and]
[(B) the board.]
(4) [(3)] The board may require a pharmacy to initiate [institute ] a recall if there is potential for [probable ] or confirmed harm to a patient.
§291.133.Pharmacies Compounding Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (9) (No change.)
(10) Drugs, components, and materials used in sterile compounding.
(A) - (G) (No change.)
(H) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.
(11) - (13) (No change.)
(e) - (f) (No change.)

Summary of FDA bill passed by Congress

Summary of FDA bill passed by Congress

Associated Press – Tue, Jun 26, 2012

WASHINGTON (AP) — President Obama is expected to sign into law a mammoth bill passed by Congress Tuesday that reshapes how the Food and Drug Administration assures the safety of the drug supply, particularly imported medicines.

The bill is a must-pass piece of legislation because it extends the 20-year program that helps fund the FDA's budget for reviewing new drugs and medical implants. But lawmakers added dozens of provisions influencing FDA policies and the drug industry.

Here's a look at some of the key changes the bill would bring:

FOREIGN INSPECTIONS: Gives the FDA more leeway to inspect drug factories in China, India and other foreign countries. FDA has long been required to inspect U.S. manufacturing sites every two years, but most drug ingredients are now made overseas. The bill frees FDA inspectors to go after foreign drug plants.

COUNTERFEIT DRUGS: Hikes the maximum penalty for drug counterfeiting to $4 million or 20 years in prison. The current maximums are $10,000 or three years in prison. Drug counterfeiting has risen steadily over the past decade, and drugmakers reported more than 1,700 worldwide last year. The FDA is investigating two faked batches of the cancer drug Avastin that reached the U.S. this year from the Middle East by way of European supply chains.

FDA REVIEW FEES: Renews, through 2017, a program under which drugmakers pay the FDA to review new medications. For the first time, it also requires generic drugmakers to pay for reviews, adding $299 million in annual fees to the $693 million paid by makers of branded drugs. The bill also renews a similar program for reviews of medical devices.

BREAKTHROUGH DRUGS: Relaxes certain requirements — including allowing smaller and shorter clinical studies — to speed approval of drugs that appear to offer innovative treatments for life-threatening diseases.

OUTSIDE INSPECTORS: Allows drugmakers to hire non-government inspectors to assess whether factories are meeting U.S. quality standards. These inspections wouldn't take the place of the FDA's but could be used to bolster a company's safety record.

DRUG SHORTAGES: Requires drugmakers to notify the government at least six months before discontinuing production of a drug. More than 280 drugs are currently in short supply, creating life-threatening delays for patients with cancer and other serious diseases. The shortages are driven by factors including consolidation in the pharmaceutical industry.

SYNTHETIC DRUGS: Bans 28 chemicals used in synthetic drugs known as "bath salts" that are often sold at corner stores as hygiene products, incense or plant food and can trigger bizarre and violent behavior.

Amendment with Respect to Misbranding Contained in Senate Bill 3187

The final version of Senate Bill 3187 as passed and headed ot the President's desk can be read by clicking here. 

One amendment provided for in the bill is an amendment to the misbranding provision as follows:

SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

Section 502 (21 U.S.C. 352) is amended by adding at the end the following:

‘(aa) If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 744A(a)(4) or for which identifying information required by section 744B(f) has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.’.

From American Society of Health-System Pharmacists

News Capsule

Drug Shortages Bill Headed to White House

6/27/2012

Thanks to ASHP’s multi-year effort to educate Congress about the public health crisis caused by drug shortages, along with work to build broad based support for the legislation in the health care community, we are closer than ever to protecting patients from the dangers posed by drug shortages. Today, the Senate passed the final version of S. 3187, “The Food and Drug Administration Safety and Innovation Act,” which included ASHP-supported drug shortages provisions. The House of Representatives passed the bill last week. The bill now goes to the President for his signature. 

“This is a very important achievement for ASHP,“ said chief executive officer Paul W. Abramowitz, Pharm.D., FASHP. “We are gratified that the determined efforts of our members and our staff resulted in this resounding victory for patients.”

ASHP is widely viewed as the most credible source of information on drug shortages. In a year when Congress experienced inertia due to partisan disagreements, the Society took the lead in bringing both parties together to help address the drug shortages crisis in a bipartisan, rational, and thoughtful manner. The Society, in collaboration with key partners, including the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP), worked closely with legislators to develop the drug shortages provisions.

ASHP championed the provision which became the centerpiece of the drug shortages legislation –an early notification system that requires drug manufacturers to notify the Food and Drug Administration (FDA) of production problems or if a product will be discontinued. Failure to comply with the early notification requirement will trigger a letter from FDA.

The bill also gives the FDA authority to expedite the review of products and new drug applications; creates a generic user fee program; and allows for repackaging of medications in short supply to be used within the same health system. 

President Obama is expected to sign the bill in the coming days. 

Pharmacies Receive Suspicious Offers of Wholesale Drugs; Importance of Following FDA Guidelines to Protect Patients Stressed

Several pharmacies in the Charlotte, NC, area have been approached by questionable drug wholesalers attempting to sell them drug supplies that may be fake, reports WSOCTV. One pharmacy owner indicated that he received calls from companies claiming to be new wholesalers on a daily basis. He indicated further that he avoids working with such companies for fear that they may be distributing dangerous counterfeits, and that he only buys drug supplies directly from the drug manufacturer. 

In an April 2012 FDA statement, the agency urges the health care community “to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States.” The statement was issued following FDA’s action of requesting that medical practices in several states stop administering drugs purchased from any foreign or unlicensed source. In the statement, FDA notes that the “Verify Wholesale Drug Distributor Licenses” FDA Web page may be used to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business. Also, suspected criminal activity can be reported to FDA's OCI by calling 800/551-3989 or completing the online form on the OCI Web Site. 

Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors^® (VAWD^®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and NABP's VAWD criteria. Wholesale distributers that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo a site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.