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
Wednesday, May 1, 2013
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
Tuesday, April 30, 2013
Statement on Veterinary Compounding from the Veterinary Council in New Zealand
Statement on Compounding Veterinary Medicines
This statement should be read in conjunction with:
• Paragraph 6 of the Veterinary Medicines section of the VCNZ Code of
Professional Conduct and related explanatory notes
• MAF Guidance on Developing a Documented System to meet conditions of
exemption from registration for Compounded Veterinary Preparations under the
ACVM (Exemption) Regulations 2011
Definitions
Compounding means to combine ingredients (for example, generic chemicals or
biological compounds or trade name products) to prepare a medication to be
dispensed to a person to treat an animal. To prepare means not only the process of
combining ingredients in an appropriate manner for the intended purpose but also
placing the medication into appropriate packaging with appropriate labelling to allow
it to be dispensed to and used by a person other than the veterinarian who
compounded it.
Practices that are also included but do not strictly fit the above definition of
compounding are:
• decanting and breaking down trade name products into smaller quantities when
there is no change in the product itself
• reconstituting trade name products, and
• preparing medications to be used immediately by the veterinarian who prepares
the medication.
Compounding Classes--
What The Proposed Federal Legislation Has to Say About Compounding from Bulk- Vets What Do You Have to Say? You Need to Be Voicing Your Opinions on How This Will Effect You!
Bulk Ingredient
Qualifications and Restriction on Wholesaling
The bulk requirements in current section 503A are
preserved, with one modification.
Current law requires that any drug compounded from bulk must use bulk
active pharmaceutical ingredient that 1) either complies with an applicable
United States Pharmacopoeia (USP) or National Formulary (NF) monograph, is part
of an FDA-approved drug, or appears on a list established by the Secretary; 2) is
manufactured in a registered establishment; and 3) is accompanied by a valid
certificate of analysis. The revised section
503A would permit the Secretary to identify a drug that only has an applicable
USP or NF monograph as not suitable for compounding following the publication
of the reasoning and consideration of comments submitted to a docket open for
at least 30 days. Inactive ingredients also must comply with USP or NF.
If a drug is being compounded for a minor animal
species, the same requirements on bulk chemicals apply. However, if a drug is
compounded for a non-food major species or food-producing animal, compounding
from bulk can only be performed if FDA has listed that bulk ingredient. The
major species are cattle, horses, swine, chickens, turkeys, dogs, and cats.
Minor animal species are all other species.
Compounded drugs may only be sold by the entity that
compounded that product, and all must be labeled “not for resale”. It is a
prohibited act to resell a product labeled “not for resale”.
quoted from the Senate's section by section paper.
Do vets have a problem with this proposed new federal legislation? If so, you need to get your comments submitted by the May 3, 2013 deadline.
ASHP Statement on HELP Committee Proposed Pharmaceutical Compounding Bill April 30th, 2013 John Buck
The American Society of Health-System Pharmacists (ASHP) is encouraged by the provisions included in draft legislation released by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to address regulatory gaps in the oversight of compounding outsourcers.
“Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a “compounding manufacturer” that would be overseen by the Food and Drug Administration (FDA).”
The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.
The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.
ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline.
Source: ASHP
Question of the Day: 4/30/2013 Doesn't Congress Needs to Listen to the Experts in the Field--the Ones Who Deal with the Real World of Compounding?
In reading articles recently posted, it is apparent that there is still much misunderstanding about compounding, compounding pharmacies and the state of the law. If as some commentators say, "the FDA dropped the ball" then why is there a need for new federal legislation giving them authority over some compounders if in fact they had authority over all compounders or at least the group recently inspected by them? If the FDA did not drop the ball and thus did not have authority to regulate, then isn't it true the states dropped the ball and that there may be a need for additonal federal legislaton of some kind?
Doesn't it make sense for Congress to get more input from the people who actually deal with compounding everyday? Why not call leading pharmcist in compounding and knowledgeable marketing directors that deal with the realities of compounding to testify before them and get their input in how the federal legislation should be drafted?
Doesn't it make sense for Congress to get more input from the people who actually deal with compounding everyday? Why not call leading pharmcist in compounding and knowledgeable marketing directors that deal with the realities of compounding to testify before them and get their input in how the federal legislation should be drafted?
Health Canada Reviews Compounding Regulations Following Drug Scare
After reports of more than 1,000 patients receiving diluted chemotherapy treatments, Health Canada has implemented an interim solution to cover gray areas in the oversight of small compounding facilities, allowing admixing to continue under strict direction.
Will Senate fix compounding pharmacy oversight this time?
The first time most people heard of a “compounding pharmacy” was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.
Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreak tied to tainted injections made by the New England Compounding Center.
More than 700 people in 20 states have been sickened, and many are still suffering.
In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?
The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency’s authority does need to be clarified and expanded.
continue reading here
Subscribe to:
Posts (Atom)