Thursday, May 2, 2013

Ten Reasons Why the Proposed Federal Compounding Legislation Should Not Be Passed In Its Current Form--Reposted from April 30, 2013


Sue Tuck Richmond
April 30, 2013

While there are good things about the proposed federal compounding legislation, there are also somethings that make this not the best possible legislation that Congress can pass. Here are ten reasons that the proposed compounding federal legislation is not a good idea to pass in its current form:

1.  Congress appears to be rushing to pass Federal legislation without taking the time to allow all affected parties time to analyze this legislation.  While Congress is asking for comments, they are not allowing much time to submit those comments.  Comments are due May 3, 2013.

2.  There are currently state rules and regulations covering some of the same areas.  These state rules and regulations need to be enforced.  Adding more piecemeal regulations when the current ones are not enforced makes little sense.

3.  The FDA already has jurisdiction over manufacturers.  If a compounding pharmacy is engaged in manufacturing the FDA should already be enforcing its laws.  A new category muddies the water, creates more gray area, and leaves open more areas for litigation.

4.  This proposed legislation contains a number of loopholes.  The bad compounders will continue to find ways around the legislation and use the loopholes to their advantages.

5.  The labeling requirements should not  only require  the name, address, and phone number of the applicable compounding manufacturer, but should also require the name of the pharmacist responsible for preparing the compound.

6.  Exempting hospitals pharmacies who ship interstate within a hospital system from the definition of compounding manufacturer or to excuse them from registration with the FDA will not save lives or ensure public safety.  People receiving these compounds deserve the same protections as everyone else.

7.   Charging a $15,000.00 fee for inspections may cause some good compounders to stop compounding much needed drugs. This is a huge amount to be charged for inspections. In addition the compounder must pay 100 percent of the cost of reinspection.

8.   Only covering preparations prepared without a prescription or in advance of prescription does not ensure public safety.  Compounds prepared with a prescription can also be deadly.  Just because the number of deaths may not be as great as in NECC this does not mean we should not do everything we can to prevent all deaths from bad compounds.

9.    This legislation will require the larger compounders who prepare prescriptions in advance of prescription or without a prescription to be monitored by the FDA but in no way ensures a way for the FDA to monitor, inspect or keep track of the "bad compounders" who do not fit the proposed definition.

10.  The legislation creates a number of areas such as who is a compounding manufacturer that could be highly litigated and take years to be settled by courts. The "bad compounders" who probably meet these definitions will have the resources and money to tie these issues up for years in court, which in effect does not truly advance the ball as far as public safety.

As a side note, Congress is spending too much time trying to place blame on someone when in truth the blame is shared by a number of people--the FDA, the states, bad compounders, organizations and lobbyists, doctors and vets not demanding the highest quality of compounds, and the public for not being educated and knowledgeable and demanding more from doctors, vets, pharmacists, the FDA and states.  Congress needs to be careful to not adopt legislation that actually punishes the the good compounders who are are making every effort to play by the rules.

Question of the Day 5/2/2013 Will Drug Manufacturers Be Able to Compound Drugs Under the Proposed Federal Legislation?

It appears they would be as long as they could meet the requirements of the proposed legislation.  Is this an intended or unintended loophole in the proposed legislation?  

Pharmacy Practice News - Botched Drugs, Broken Trust

Agenda for Alaska Board of Pharmacy May Meeting Includes Discussion of High Risk Pharmacy Inspections


STATE OF ALASKA
DEPARTMENT OF COMMERCE, COMMUNITY AND ECONOMIC DEVELOPMENT
DIVISION OF CORPORATIONS, BUSINESS AND PROFESSIONAL LICENSING
ALASKA STATE BOARD OF PHARMACY
550 W. 7TH AVE. STE. 1270, ANCHORAGE, ALASKA
TENTATIVE MEETING AGENDA
May 9-10, 2013
 Item Time Topic Packet Lead Person
 9:00 a.m. Call to Order/Roll Call Dick Holm, Chair
1. 9:05 a.m. Review Agenda Chair
2. 9:10 a.m. Review Minutes Tab 1 Chair
 3. 9:15 a.m. Ethics Disclosure Tab 2 Chair
 4. 9:20 a.m. Division Update Tab 3 Chair
 Expense Report
 5. 9:45 a.m. PDMP Tab 4 Brian Howes, Program Mgr
 Program Report Chair
 10:15 a.m. Break
 6. 10:30 a.m. Legislative Report Tab 5 Chair
 7. 10:45 a.m. Regulation Projects Tab 6 Jun Maiquis, Reg Specialist
 Facility Inspections Chair
PDMP Exemption
 Pharmacist Reinstatement
 12:00 p.m. Lunch
 8. 1:00 p.m. UAA/ISU Joint Pharmacy Tab 7 Chair
 Program
 Cathy Cashmore presenter
 9. 1:30 p.m. Investigator Report Tab 8 Al Kennedy, Investigator
 10. 2:15 p.m. New Business Tab 9 Chair
Facility Licensing
Hydrocodone reclassification
FDA Sharing Information
 Temporary permits/military training
3:15 p.m. Break
 11. 3:30 p.m. Old Business Tab 10 Chair
Labor Laws
High Risk Pharmacy inspections
4:00 p.m. Recess until May 10th – 9:00 a.m. ALASKA STATE BOARD OF PHARMACY
 MEETING AGENDA
 Friday, May 10, 2013
Item Time Topic Packet Lead Person
 9:00 a.m. Call to Order/Roll Call Dick Holm, Chair
 12. 9:05 a.m. Review Agenda Chair
13. 9:10 a.m. Correspondence Tab 11 Chair
 14. 9:45 a.m. AkPha Report Chair
 * Nancy Davis not available
 15. 10:00 a.m. Public Comment Chair
 16. 10:15 a.m. License Application Review Tab 12 Chair
17. 11:00 a.m. Annual Report Tab 13 Chair
Narrative
 Budget request
 Legislative request
18. 11:30 a.m. Office Business Chair
 TA’s
 Wall Certificates
 11:45 p.m. Adjourn

Wednesday, May 1, 2013

Public Citizen to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety


tatement of Dr. Michael Carome, Deputy Director, and Sarah Sorscher, Attorney, Public Citizen's Health Research Group

After a tainted drug from a New England compounding pharmacykilled 53 people and exposed a major safety problem posed by a growing illegal drug manufacturing industry, one would think that lawmakers would leap to correct the problem and boost patient safety.

Not this Congress. Senate lawmakers are proposing what amounts to a giant step backward for U.S. drug safety and quality control.

Draft legislation on pharmacy compounding released Friday, April 26, by the U.S. Senate Committee on Health, Education, Labor and Pensions (the Senate HELP Committee) would dramatically weaken patient protections by creating an extremely dangerous new class of drug manufacturers, confusingly called "compounding manufacturers." (In contrast to drug manufacturing, pharmacy compounding involves a pharmacist preparing, in response to a physician's prescription, an individually customized drug for one patient who has unique medical needs that cannot be met by a commercially available, Food and Drug Administration (FDA)-approved drug manufactured by a pharmaceutical company.)

These second-tier manufacturers would be permitted to mass-produce standardized drugs and sell across state lines without obtaining FDA approval or meeting federal labeling requirements intended to ensure the safe use of drugs — requirements currently mandated for all drug manufacturers.

Rather than strengthening the FDA's authority over high-risk manufacturing activities, this bill would remove important federal requirements that protect patients from unsafe and ineffective drugs and bring about massive deregulation of a growing industry of second-tier drug manufacturing — an industry that has been permitted to thrive under the guise of "pharmacy compounding" in violation of current federal law due to lax FDA enforcement. Even worse, the substandard drugs manufactured by proposed second-tier "compounding manufacturers" would carry no warning label to notify hospitals, doctors and patients that drugs made by this industry are not approved by the FDA or evaluated by the FDA for safety, efficacy and accurate labeling.

Under current law, compounding pharmacies that mass produce standardized products, as opposed to producing customized drugs to meet an individual patient's needs, are considered drug manufacturers and are subject to FDA regulation. As manufacturers, these firms can be prosecuted if they fail to register with the FDA,submit to FDA inspections, obtain FDA pre-market approval, followgood manufacturing practices, report adverse events or take certain steps to avoid false or misleading labeling.

In the past, the FDA has been slow to enforce these laws against companies calling themselves "compounding pharmacies," even where they engage in manufacturing activity. The agency can correct that error by taking swift, aggressive action to identify and prosecute these companies under existing statutory authority.

Yet rather than pushing the FDA to fully use its existing authority and giving the agency enhanced authority to monitor and inspect all compounding pharmacies, the Senate HELP Committee proposal ratifies and endorses the FDA's history of under-enforcement, allowing "compounding manufacturers" to continue manufacturing drugs under greatly weakened federal standards.

Under these clearly weakened standards, "compounding manufacturers" would only have to comply with limited federal requirements (such as good manufacturing practices, registration and some post-marketing inspection requirements), but could mass-produce new drugs without obtaining FDA premarket approval or complying with federal labeling requirements. As a result, "compounding manufacturers" could manufacture new drug formulations and combinations that have not been evaluated for safety and efficacy and could launch new, untested manufacturing processes without first receiving an inspection or approval by the FDA. They also would not be required to include labels that explain how to safely use the product, including indications for use, precautions and warnings about serious toxicities, and contraindications for use.

The proposed legislation also fails to adequately strengthen federal oversight of traditional compounding pharmacies. Under the new law, these companies would be entirely exempt from FDA authority, including registration and inspection requirements. This would make it harder for the FDA to police the line between traditional compounding and drug manufacturing, a major problem because the definition of "traditional compounding" in the statute is overly broad, ambiguous and subject to abuse.

The American public deserves better. Congress should reject the HELP Committee proposal and instead adopt legislation that would:

- Draw a single, clear line between traditional compounding and drug manufacturing, with no newly created category of second-tier, substandard drug manufacturers, called "compounding manufactures";

- Provide adequate funding to the FDA to aggressively enforce existing laws against "compounding pharmacies" that cross the line into manufacturing;

- Strengthen the FDA's authority to police the line between traditional compounding and drug manufacturing by requiring registration and granting the FDA authority to inspect for traditional compounding pharmacies, regardless of whether they engage in drug manufacturing activities; and

- Require clear, standardized warning labels to communicate to providers and patients who purchase traditional compounded products that the safety, efficacy and the accuracy of the product's labeling have not been assessed by the FDA.

quoted from source found here

Bill to Strengthen Regulation of Compounding Introduced in Maine Legislature

A bill (LD1315) to strengthen the regulation of compounding pharmacies in Maine was introduced to the state’s legislature. The proposed law would require pharmacies compounding medications to obtain a special license, and would require that all pharmacies dispensing compounded drugs to patients in Maine be licensed by the state. The bill also proposes to change the structure of the Maine Board of Pharmacy by removing two pharmacists and replacing them with a physician and a nurse, reports the Kennebec Journal. If the bill becomes law, nonresident pharmacies that fail to comply with Maine regulations for compounding could face fines of up to $25,000.


APhA says: Senate draft proposal would clarify FDA authority over high-risk compounding


Compounders would be subject to greater oversight and stricter standards

Drafted by a bipartisan group from the Senate Health, Education, Labor, & Pensions (HELP) Committee led by Chair Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), Pat Roberts (R-KS), and Al Franken (D-MN), the draft legislation “clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation,” according to a statement from the committee.New Senate draft legislation introduced April 26 would give FDA greater authority over compounding pharmacies and distinguish clearly between traditional compounding pharmacies and compounding manufacturers.
The draft legislation defines compounding manufacturers as entities that compound sterile drugs without patient-specific prescriptions and sell the drugs across state lines, whereas traditional pharmacies compound drugs based on specific prescriptions for individual patients. In addition, “any entity that pools sterile products or repackages sterile, single-use, preservative-free vials” is a compounding manufacturer, the draft proposal states, and cannot be licensed as a pharmacy.
Following are highlights of the draft proposal:
  • Compounded drugs would be considered new drugs that are subject to the Federal Food, Drug, and Cosmetic Act. Compounders would not be allowed to compound complex dosages or biologic products made from live organisms. They would also be prohibited from compounding variations of marketed FDA-approved drugs unless the products fulfill a specific patient need or drug shortages occur. In addition, the bill would prohibit compounding of products that are subject to certain Risk Evaluation and Mitigation Strategies unless the compounders use comparable safety controls.
  • Compounding manufacturers would be required to register with FDA, inform the agency what products they have made, and compound drugs under a pharmacist’s direct oversight. They would also have to comply with current Good Manufacturing Practices, investigate and report adverse events, and label compounded products.
  • Compounding manufacturers with more than 25 employees would pay an annual fee of $15,000 (with an inflation adjustment) to defray the cost of FDA inspections.
  • Wholesaling regulations would allow only the company that compounded products to sell them, and all drugs would be labeled “not for resale.”
Although state boards of pharmacy would continue to license and regulate traditional compounding pharmacies, the bill would increase communication between states and FDA and encourage communication among states, according to a summary of the draft proposal. For example, if FDA received a complaint from a state regulatory agency about a traditional pharmacy or product, FDA would inform the state pharmacy board.

Continue reading here

Question of the Days: 5/1/2013 How many Senators and Representatives Actually Understand the Importance of Compounding Animal Drugs from Bulk or Even What Drugs Will Not Be Available If Animal Drug

Cannot be Compounded from Bulk?

Anesthesiology News - Doctor Group Claims Drug Purchasing Organizations Causing Chronic Shortages

FDA Law Blog Summary of Draft Compounding Legislation by Karla L. Palmer