Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, May 2, 2013
Senate Hearing Scheduled for May 9th to discuss draft legislation
Senate Drug Compounding Hearing Slated For Thursday
The Senate Health, Education, Labor and Pensions Committee will hold a hearing Thursday (May 9) to discuss the panel's recent bipartisan drug compounding proposal, . . .
HHS Official Pledges Guidance To Ease Compliance With HIPAA Privacy Rule
An HHS official responsible for writing the recently released omnibus rule for strengthening the privacy and security of patient data said the agency would soon be releasing a series of guidance documents to ease industry compliance with the new requirements that go into effect in September.
Source found here
Source found here
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?
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 giantstep 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, compoundingpharmacies 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.
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
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
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
May 01, 2013
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
FDA Law Blog Summary of Draft Compounding Legislation by Karla L. Palmer
Senate’s HELP Committee Releases Draft Compounding Legislation; Seeks Stakeholders’ Written Comments by May 3, 2013
By Karla L. Palmer –
The Senate’s Health, Education, Labor and Pensions (“HELP”) Committee released draft legislation on Friday, April 26, 2013, that would replace section 503A of the Federal Food, Drug & Cosmetic Act (“FDCA”), amend other sections, and clarify FDA’s authority to regulate pharmaceutical compounders and compounded pharmaceutical products. Interested persons, industry and other stakeholders are asked to submit written comments concerning the draft legislation tocompounding@help.senate.gov by 6:00 PM on May 3, 2013. The draft legislation is available here, along with a summary, and an easily digestiblesection-by-section analysis of the draft bill.
Set forth below is a summary of the draft legislation:
Compounded Drugs Would Be Considered “New Drugs.” In a section titled, “Clarification of New Drug Status” the proposed legislation explicitly clarifies that compounded drugs are “new drugs” subject to regulation under the FDCA. This clarification would put to rest decades of ambiguity concerning whether the FDCA’s provisions relating to new drug approval requirements apply to compounded drug products.
The Proposed Legislation Seeks to Establish Clear Regulatory Boundaries By Defining “Traditional Compounder” and “Compounding Manufacturer.” The legislation would create two categories of compounding pharmacies: “traditional compounders” and “compounding manufacturers.”
Compounding Manufacturer. The draft defines “compounding manufacturer” as an entity that: (1) makes sterile drug products without receiving or in advance of a prescription and introduces those drugs in interstate commerce; or (2) “repackage[s] a drug using sterile preservative-free single-dose vials or by pooling sterile drugs.” Compounding manufacturers would be required to pay FDA annual registration fees, follow statutory restrictions on drugs they can compound (both for humans and animals), submit to FDA inspections similar to those conducted of drug manufacturers, and make regular reports to FDA pursuant to a national, uniform set of rules. Drugs compounded by newly defined compounding manufacturers that meet the requirements set forth in the new section 503A would be exempt from the Act’s requirements regarding adequate directions for use (Sec. 502(f)(1)) and the new drug approval provisions (Sec. 505 for human drugs and Sec. 512 for animal drugs), but are subject to current Good Manufacturing Practices (“cGMP”) applicable to drug manufacturers. In order for the exemptions to apply, the compounding manufacturer would have to comply with the other provisions of the legislation, and cannot be licensed as a pharmacy in any state.
More specifically, under the legislation, compounding manufacturers would have to:
- Ensure that a pharmacist, licensed in the state where the compounding manufacturer is located, exercises direct supervision over the operations of the compounding manufacturer.
- File with FDA every six months a list of drugs compounded during the previous six month period (including active ingredients, NDC numbers, the strength of active ingredients per unit, dosage form and route of administration, number of individual units produced, the NDC of the final product, and other requirements as established by FDA pursuant to regulation).
- Report to FDA any serious adverse drug experience not later than 15 days after receipt of information about the adverse event and maintain records of serious adverse drug experiences for 10 years.
- Label compounded drugs with the following statement: “This is a compounded drug,” or a reasonable comparable alternative statement (as specified by FDA). The label also would include the name, address, and phone number of the compounding manufacturer; the lot or batch number; established name of the medication; strength; statement of quantity; directions for use; date the product was compounded; the “beyond use date;” storage instructions; and other information that the FDA determines is necessary.
- Pay registration fees. For compounding manufacturer establishments with more than 25 employees, the annual fee would be $15,000 (subject to inflation); those with less than 25 employees would pay roughly one-third of that fee. To the extent that FDA must reinspect a compounding manufacturer, that entity would be responsible for 100% of the reinspection-related costs. All fees collected will be used by FDA solely to pay costs associated with inspections.
Traditional Compounders. As defined by the legislation, a “traditional compounder” requires a licensed pharmacist in a state-licensed pharmacy, a licensed physician or licensed veterinarian, to the extent permitted under state law, to compound a drug, but only (1) upon receipt of a prescription for an individual patient; or (2) in limited quantities before receipt of a prescription for an individual patient if such compounding is based on an “established history” of such prescriptions. Compounded drugs meeting the requirements set forth in the new 503A would be exempt from FDA’s cGMP (Sec. 501(a)(2)(B)), adequate directions for use requirements (Sec. 502(f) (1)), and the new drug provisions of the FDCA (Sec. 505 for human drugs and Sec. 512 for animal drugs).
The Proposed Legislation Contains An Exemption for Hospital Pharmacies. A pharmacy located within a “health system” that compounds and ships drugs for dispensing within that health system (which may include interstate shipment) is considered a traditional compounder, subject to specified conditions, if it otherwise meets the definition of a traditional compounder.
Prohibitions on Compounding Certain Drugs. The draft legislation states that certain drugs may not be compounded except under limited circumstances. Those drugs include complex dosage forms and biologics as designated by FDA pursuant to regulation (this may include “extended release products, metered dose inhalers, transdermal patches, and liposomal products”).
Copies of marketed animal or human drugs, including variations of such drugs compounded from bulk substances also could not be compounded, with a few exceptions. These exemptions include: (1) if the compounder receives a prescription order for an identified individual patient indicating that the compounded variation produces for that patient a significant difference, as determined by the prescribing practitioner; (2) for copies of marketed FDA-approved drugs, if the drug at the time of compounding and its distribution is on FDA-maintained drug shortage lists, and the compounder notifies FDA prior to compounding.
Other Provisions. The draft legislation also contains restrictions on the bulk chemicals that can be used in compounding, prohibits compounding manufacturers from selling to middlemen or wholesalers. Lastly, references in the draft legislation to a prescription order for an “identified individual patient” would, in the case of animals, include a prescription order for a specific herd or flock of animals.
quoted from source found here
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