New Legislation in Virginia Dealing With Compounding

New Legislation in Virginia Dealing with Compounding:

VIRGINIA ACTS OF ASSEMBLY -- 2012 SESSION
CHAPTER 173
An Act to amend and reenact § 54.1-3410.2 of the Code of Virginia, relating to pharmacists' authority
to compound.
[H 733]
Approved March 8, 2012
Be it enacted by the General Assembly of Virginia:
1. That § 54.1-3410.2 of the Code of Virginia is amended and reenacted as follows:
§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certain conditions; labeling
and record maintenance requirements.
A. A pharmacist may engage in compounding of drug products when the dispensing of such
compounded products is (i) pursuant to valid prescriptions for specific patients and (ii) consistent with the provisions of § 54.1-3303 relating to the issuance of prescriptions and the dispensing of drugs.
Pharmacists shall label all compounded drug products that are dispensed pursuant to a prescription inaccordance with this chapter and the Board's regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.
B. A pharmacist may also engage in compounding of drug products in anticipation of receipt of
prescriptions based on a routine, regularly observed prescribing pattern.
Pharmacists shall label all products compounded prior to dispensing with (i) the name and strength of the compounded medication or a list of the active ingredients and strengths; (ii) the pharmacy's assigned control number that corresponds with the compounding record; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and
(iv) the quantity.
C. In accordance with the conditions set forth in subsections A and B, pharmacists shall not
distribute compounded drug products for subsequent distribution or sale to other persons or to
commercial entities, including distribution to pharmacies or other entities under common ownership or control with the facility in which such compounding takes place.
A pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions
to alternate delivery locations pursuant to § 54.1-3420.2.
A pharmacist may also provide compounded products to practitioners of medicine, osteopathy,
podiatry, dentistry, or veterinary medicine to administer to their patients in the course of their
professional practice, either personally or under their direct and immediate supervision.
Pharmacists shall label all compounded products distributed to practitioners for administration to their patients with (i) the statement "For Administering in Prescriber Practice Location Only"; (ii) the name and strength of the compounded medication or list of the active ingredients and strengths; (iii) the facility's control number; (iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (v) quantity.
D. Pharmacists shall personally perform or personally supervise the compounding process, which
shall include a final check for accuracy and conformity to the formula of the product being prepared,
correct ingredients and calculations, accurate and precise measurements, appropriate conditions and
procedures, and appearance of the final product.
E. Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile
compounding.
F. Pharmacists may use bulk drug substances in compounding when such bulk drug substances:
1. Comply with the standards of an applicable United States Pharmacopoeia or National Formulary
monograph, if such monograph exists, and the United States Pharmacopoeia chapter on pharmacy
compounding; or are drug substances that are components of drugs approved by the FDA for use in the United States; or are otherwise approved by the FDA;
2. Are manufactured by an establishment that is registered by the FDA; or
3. Are distributed by a licensed wholesale distributor or registered nonresident wholesale distributor,
or are distributed by a supplier otherwise approved by the FDA to distribute bulk drug substances if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer reputation, or reliability of the source.
G. Pharmacists may compound using ingredients that are not considered drug products in accordance with the USP-NF standards and guidance on pharmacy compounding.
H. Pharmacists shall not engage in the following:
1. The compounding for human use of a drug product that has been withdrawn or removed from the
market by the FDA because such drug product or a component of such drug product has been found to be unsafe. However, this prohibition shall be limited to the scope of the FDA withdrawal; or
2. The regular compounding or the compounding of inordinate amounts of any drug products that are essentially copies of commercially available drug products. However, this prohibition shall not include
(i) the compounding of any commercially available product when there is a change in the product
ordered by the prescriber for an individual patient, (ii) the compounding of a commercially
manufactured drug only during times when the product is not available from the manufacturer or
supplier, or (iii) the compounding of a commercially manufactured drug whose manufacturer has
notified the FDA that the drug is unavailable due to a current drug shortage, (iv) the compounding of a commercially manufactured drug when the prescriber has indicated in the oral or written prescription for an individual patient that there is an emergent need for a drug that is not readily available within the time medically necessary, or (v) the mixing of two or more commercially available products regardless of whether the end product is a commercially available product.
I. Pharmacists shall maintain records of all compounded drug products as part of the prescription,
formula record, formula book, or other log or record. Records may be maintained electronically,
manually, in a combination of both, or by any other readily retrievable method.
1. In addition to other requirements for prescription records, records for products compounded
pursuant to a prescription order for a single patient where only manufacturers' finished products are used as components shall include the name and quantity of all components, the date of compounding and dispensing, the prescription number or other identifier of the prescription order, the total quantity of finished product, the signature or initials of the pharmacist or pharmacy technician performing the compounding, and the signature or initials of the pharmacist responsible for supervising the pharmacy technician and verifying the accuracy and integrity of compounded products.
2. In addition to the requirements of subdivision I 1, records for products compounded in bulk or
batch in advance of dispensing or when bulk drug substances are used shall include: the generic name and the name of the manufacturer of each component or the brand name of each component; the manufacturer's lot number and expiration date for each component or when the original manufacturer's lot number and expiration date are unknown, the source of acquisition of the component; the assigned lot number if subdivided, the unit or package size and the number of units or packages prepared; and the beyond-use date. The criteria for establishing the beyond-use date shall be available for inspection by the Board.
3. A complete compounding formula listing all procedures, necessary equipment, necessary
environmental considerations, and other factors in detail shall be maintained where such instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product.
4. A formal written quality assurance plan shall be maintained that describes specific monitoring and
evaluation of compounding activities in accordance with USP-NF standards. Records shall be maintained showing compliance with monitoring and evaluation requirements of the plan to include training and initial and periodic competence assessment of personnel involved in compounding, monitoring of environmental controls and equipment calibration, and any end-product testing, if applicable.
J. Practitioners who may lawfully compound drugs for administering or dispensing to their own
patients pursuant to §§ 54.1-3301, 54.1-3304, and 54.1-3304.1 shall comply with all provisions of this section and the relevant Board regulations.

Another Article Suggest that the FDA May Start Inspecting More Compounding Pharmacies

Another article entitled Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall by Alexander Gaffney  suggest that the FDA may start inspecting more compounding pharmacies.  The article states:

Not all pharmacists have the same level of skills and equipment,” said Rear Admiral Steven Galson, deputy director of the Center for Drug Evaluation and Research at FDA and the US’s acting surgeon general. “In some cases, compounders may lack sufficient controls—equipment, training, testing, or facilities—to ensure product quality or to compound complex products such as sterile or modified release drugs.”

Because the majority compounds are made-to-order and exist in small quantities, many current good manufacturing practices such as lot and batch testing are impossible. “The quality of the drugs that these pharmacists compound is uncertain and these drugs pose potential risks to the patients who take them,” concluded Galson.

However, large-volume suppliers such as Franck’s are frequently making batches of products in amounts suitable for quality testing, creating tensions between FDA and the compounders, report The Star-Banner.

In response, FDA is starting to leverage its oversight authority towards companies “whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of” The Federal Food, Drug and Cosmetic Act, said Galston in previous testimony before Congress.

To read the entitle article, click here.

House Passes FDA Reform Act of 2012

The U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. The U.S. Senate had already passed its version of the bill. See previous post and here. This House Report explains the bill’s history and includes a section-by-section analysis. Both bills reauthorize and amend old (PDUFA and MDUFA) and establish new (GDUFA and BsUFA) user fee statutes, permanently reauthorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.  Next, a conference committee will reconcile differences between the House and Sentate bills. The Senate bill contains provisions, not included in the House bill, such as provisions on drug track and trace, Risk Evaluation and Mitigation Strategies, and changes to the Controlled Substances Act.  The House bill contains provisions on generic drug 180-day exclusivity forfeiture, citizen petitions, and drug shortages not included in the Senate bill. The Congressional Research Service has a side-by-side comparison of current law, S. 3187 and H.R. 5651. After the committee reaches a compromise on differences in the House and Senate bill, the legislation will be sent to the President for his signature.  This is expected to happen by the end of June or early July.

U.S. Senate passed the Food and Drug Administration Safety and Innovation Act

Senate Easily Passes FDA User Fee Bill, Reconciliation with House Version Looms

article found here.

by McDermott Will & Emery on 5/30/2012

authors: James S. Cohen and Michael W. Ryan]
In a nearly unanimous decision, the U.S. Senate passed the Food and Drug Administration Safety and Innovation Act on May 24, 2012. The bill would reauthorize the drug and device user fee programs and, for the first time, allow the Food and Drug Administration (FDA) to collect user fees from generic drug and biosimilar manufacturers. The bill is expected to raise $6.4 billion over the next five years to cover a portion of the costs of the FDA’s review of medical product marketing applications. In addition, the bill would implement a number of changes to the FDA’s review and oversight of drugs, devices and biologicals. The House of Representatives is expected to take up consideration of a similar House bill this week.
After months of negotiations, on May 24, 2012, the U.S. Senate passed the Food and Drug Administration Safety and Innovation Act, a bipartisan bill that would reauthorize the Food and Drug Administration (FDA) drug and medical device “user fee” programs and, for the first time, allow the agency to collect user fees from generic drug and biosimilar manufacturers. The bill, which passed by a vote of 96-1, is expected to raise $6.4 billion for the FDA over the next five years, which will be used to cover a portion of the costs associated with the agency’s review of marketing applications for the above-referenced products.
In addition to the user fee authorizations/reauthorizations, the bill proposes a number of changes to the agency’s oversight of drugs, medical devices and biologicals. Specifically, the bill would:

• Allow the FDA to change the classification of a device by administrative order. Such changes—which are currently made only through regulation—must be proposed by the Director of the Center for Devices and Radiological Health (CDRH) and issued by the Commissioner.
• Expressly require the FDA to extend its “Sentinel” post-market risk identification and analysis system to include medical devices. To ensure effective implementation, the FDA would be required to engage outside stakeholders through a public hearing, advisory committee meeting, public docket or similar public measure.
• Require the FDA to issue proposed regulations establishing a unique device identification (UDI) system by December 31, 2012. The FDA would be required to finalize the regulations within six months of the close of the comment period on the proposed rule, and to implement the regulations for implantable, life-saving and life-sustaining devices within two years of the UDI regulations being finalized. The legislation aims to speed up the process of implementing UDI regulations, which have been under development at the FDA for some time.
• For medical devices, require the FDA to provide a “substantive summary of the scientific and regulatory rationale” for decisions to deny clearance of a premarket clearance submission under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), to deny approval of a premarket approval application or to disapprove of an investigational device exemption application to conduct a clinical trial. In addition, applicants who receive a negative response on one of the above-referenced applications will be permitted to request a supervisory review of the decision to deny clearance or approval (i.e., review by an individual “at the organizational level above the organization level at which the decision to deny the clearance of the report or approval of the application is made”) within 30 days of receiving such response.
• Permit the FDA to classify a new medical device without predicates directly through de novo review into Class I or II without first requiring a “not substantially equivalent” determination under the 510(k) clearance process. The FDA may refuse to consider such a request, however, if it identifies a legally marketed device that could provide a reasonable basis for review of a substantially equivalent determination; if it determines the device is not of low-moderate risk; or if it determines “general controls” would be inadequate to control risk and “special controls” to mitigate risks cannot be developed for the proposed device.
• Prohibit the FDA from releasing final guidance on medical mobile applications until the FDA drafts a report that “contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology software, including mobile applications,” and convenes a working group to provide input on the contents of the report. The bill would require the FDA to submit this report to Congress no later than 18 months after the date of the bill’s enactment. The FDA had issued a draft guidance establishing a risk-based model for how it would regulate mobile medical applications, and the legislation would require the FDA to issue a report to explain the FDA’s approach after convening a working group that would include a variety of external stakeholders. While many application developers welcome a comprehensive, consistent and risk-based approach and the involvement of external stakeholders in the development of mobile medical application policy, there is some concern on the part of the developers (and the FDA) about a process that would delay providing the industry with regulatory clarity on the use of innovative and important medical mobile applications.
• Require the FDA to withdraw its draft “Guidance for Industry and Staff – 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” The draft guidance, which was released in July 2011, has been heavily criticized by the device industry, with one reported estimate that the new guidance will increase the number of devices subject to the 510(k) clearance process anywhere from 300 percent to 500 percent. Consistent with this concern, during a March 2012 congressional hearing, CDRH Director, Dr. Jeffrey Shuren, noted that implementation of the draft guidance may lead to some unintended consequences and indicated the FDA intends to rework the guidance document. In addition to requiring the withdrawal of the draft guidance, the bill would require the FDA to ensure affected stakeholders are provided with an opportunity to comment on any future guidance before the document is made final.
• Expand the information required of domestic and foreign facilities that manufacture, prepare, propagate, compound or process FDA-regulated products. Domestic and foreign drug establishments would be required to report their unique facility identifier, a point of contact’s e-mail address and information about each drug importer that takes physical possession of the drug (among other information). Foreign device facilities would be required to submit their name and place of business, the name of the U.S. agent for the facility, place of business and the name of each person who imports or offers to import such device into the United States. The bill authorizes the FDA to “specify the unique facility identifier system.”
• Require the FDA to carry out drug facility inspections according to a risk-based schedule. Factors that the FDA would be required to consider in assessing risk include the compliance history of the establishment, the record, history and nature of recalls linked to the establishment, and the inherent risk associated with the drug manufactured, prepared, propagated, compounded or processed at the establishment, among others.
• Allow the FDA to require establishments and wholesale drug distributors to notify the FDA of “substantial loss or theft” of drug, or if a drug has been or is being counterfeited and is in commerce in the United States or offered for import into the United States. These notifications must be made “in a reasonable time, in such reasonable manner, and by such reasonable means as the [FDA] may require.”
• Enhance penalties for knowingly and intentionally adulterating, counterfeiting and/or forging drugs. An individual who knowingly and intentionally adulterates a drug in a manner that has reasonable probability of causing serious adverse health consequences or death shall be imprisoned for a maximum of 20 years and/or fined up to $1 million. Individuals who are convicted of knowingly and intentionally counterfeiting or forging drugs may also be imprisoned for up to 20 years and/or fined up to $4 million. The penalties for either violation are currently capped at up to three years of imprisonment and/or a $10,000 fine.
• Extend market exclusivity for certain new antibiotics intended to treat serious or life-threatening infections by five years. Conditions identified as potentially serious or life-threatening include conditions caused by resistant gram-positive pathogens, multi-drug resistant gram negative bacteria, multi-drug resistant tuberculosis and C. difficile. Products intended to treat these conditions are also eligible for priority marketing application review.
• Require manufacturers of certain drugs to notify the FDA at least six months before taking action that would result in a permanent discontinuance of the manufacture of a drug or an interruption of the manufacture of a drug that could lead to a meaningful disruption in overall drug supply. This requirement would apply to manufacturers of drugs that are life-supporting, life-sustaining, intended for use in the prevention of a debilitating disease or condition, a sterile injectable product, or used in emergency medical care or during surgery (excluding products that are radiopharmaceuticals, human tissue replaced by a recombinant product, a product derived from human plasma or any other product designated by the FDA).
• Require the FDA to consider, before the issuance of enforcement action, the effect of such action on the availability of certain drugs. While the FDA often considers potential shortages when determining the extent or nature of enforcement action (e.g., in injunction actions), particularly for vaccines or sole source products, this provision would affirmatively require the FDA to consider the effect of any enforcement action or issuance of a warning letter that the FDA determines could “reasonably be anticipated to lead to a meaningful disruption” in the supply of certain drugs, e.g., drugs that are life-supporting, life-sustaining, intended for use in the treatment of a debilitating disease or condition, a sterile injectable product, or used in emergency medical care or during surgery (excluding products that are radiopharmaceuticals, human tissue replaced by a recombinant product, a product derived from human plasma or any other product designated by the FDA), in the United States. The FDA would be required to consult with an office of the FDA with expertise in drug shortages in making this determination.
• Require the FDA to issue guidance describing its policy on the promotion of FDA-regulated products on the internet. The guidance must be issued within two years after the date of enactment of the legislation. This provision would speed up the FDA’s development and issuance of guidance, and provide more clarity to the industry, on internet-related advertising, including through social media.
• Provides that the elements to assure safe use in a risk evaluation and management strategy (REMS) may not be used to prohibit access to a drug or biological by a generic drug or biosimilar manufacturer. The bill states that as part of each REMS program, the FDA shall require that the holder of an application for an innovator drug or biological not restrict the resale of the drug or biological to an eligible generic drug or biosimilar developer for the purpose of testing in support of a generic or biosimilar marketing application if the manufacturer of the innovator product receives written notice from the FDA.
• Require the FDA to develop and implement strategies to solicit the views and perspectives of patients during product development and regulatory discussions. The bill identifies “fostering participation of a patient representative” to participate in agency meetings with clinical trial sponsors and investigators, and “exploring means to identify patient representatives who do not have any, or have minimal financial interest in the medical products industry” as methods for the FDA to facilitate public participation. This provision is consistent with developments in personalized medicine and risk-benefit analysis reforms to more expressly include patient views and patient risk tolerance in the review of data in support of marketing applications.

The Senate bill is also notable for its exclusion of several widely publicized proposed provisions, including proposals to allow United States citizens to import drugs from Canadian pharmacies; to revoke exclusive marketing rights from manufacturers found to be at fault for violations of the FDCA, the False Claims Act (e.g., off-label promotion) or the Anti-kickback Statute (among others); to discourage so-called “pay for delay” patent settlements that are purported to delay generic drugs from entering the market; and to limit enforcement relating to dietary supplements.

With the Senate’s vote, the Food and Drug Administration Safety and Innovation Act now moves to the House of Representatives, which has been working on its own version of a user fee bill. The House bill, which was recently reported from the House Energy and Commerce Committee, differs in some respects from the Senate bill described above, and thus, the chambers will likely iron out any differences between the two bills through a formal or informal “reconciliation process” prior to submitting a final bill for President Obama’s signature. Notwithstanding this remaining process, members of both chambers of Congress are aiming to have a final bill on the President’s desk by the first week of July—well before the FDA’s current authorization to charge user fees expires on September 30, 2012.

Implications

In a surprising show of bipartisan cooperation, the Senate’s nearly unanimous approval of the Food and Drug Administration Safety and Innovation Act is an important step toward ensuring the FDA has the financial resources it needs to continue to review marketing applications for FDA-regulated products. Because the majority of the funding required to review marketing applications comes from user fees, the agency’s inability to charge such fees would significantly inhibit its ability to review applications in a timely manner.

The nearly unanimous passage of the Senate bill and the absence of some of the more controversial provisions that had been under discussion, or proposed as amendments, signifies congressional and administration recognition of the importance of prompt review and approval of innovative and life-saving medical products for patients. In addition, the bipartisan passage of the bill represents acknowledgment that speedier review and approval of medical products provides incentive for investments in important medical research.

The full House of Representatives is expected to take up consideration of the House bill this week (week of May 28, 2012).

Clean Room Environmental Best Practices for Medical Device & Pharmaceutical Manufacturers are Focus of Boston Seminar on June 6

AGAWAM, Mass., May 30, 2012 /PRNewswire/ -- Sterile manufacturing environments at medical device and pharmaceutical companies require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. To help, laboratory testing experts will present "Clean Room Environmental Best Practices," a special seminar in Boston on Wednesday, June 6, 2012.

The seminar is designed for all professionals responsible for building, validating, and maintaining controlled environments in the medical device and pharmaceutical industries. The program will include technical presentations on:

• Best practices for qualifying and maintaining clean room facilities
• "The people factor" in terms of containment control
• Qualifying and evaluating clean room disinfectants
• Difficult challenges: Practical advice and solutions

Opportunities for questions and continuing interaction will be encouraged.
"Clean Room Environmental Best Practices" is scheduled for 10 a.m. to 2 p.m. on Wednesday, June 6, 2012, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts — located just minutes from Boston. The cost is $149. Breakfast, lunch, and networking opportunities are included.
The seminar is sponsored by Microtest Laboratories, a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest's environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

For more information, click here.

Perry Drug in Overland Park: Final Order

Final Order against Perry Drug  in Overland Park, Kansas can be seen here.  This pharmacy was charged with compounding drugs in advance without a label and without the proper expiration date.

North Dakota Proposed Rules for Nonsterile and Sterile Compounding

On March 12, 2012, the North Dakota State Board of Pharmacy posted the following letter:


Full Notice
NOTICE OF INTENT TO [ADOPT, AMEND, OR REPEAL] ADMINISTRATIVE RULES
TAKE NOTICE that the North Dakota State Board of Pharmacy will hold a public
hearing to address proposed N.D. Admin. Code Article 61; 61-02-01-03 Pharmaceutical
Compounding Standards.  The Hearing will be held at 10:00 AM on Thursday,
November 17, 2011, at the Board of Pharmacy Office – 1906 East Broadway  in
Bismarck  ND 58501.
The purpose of these proposed rule in 61-02-01-03 are to set standards for both nonsterile and sterile compounding [United States Pharmacopeia guidelines have been in
place since June 2008].   This rule, once adopted, will give specificity to those
individuals and entities in North Dakota wishing to compound pharmaceuticals, both
non-sterile and sterile.    This rule will give North Dakota entities a basis for coming into
compliance with professional standards and a timeline for doing so.
The proposed compounding rules may have an impact on the regulated community in
excess of $50,000. The regulatory analysis can be obtained at the location bellow.
The proposed rules may be reviewed at the office of the ND State Board of Pharmacy –
1906 E Broadway – Bismarck ND 58501 or Board website www.nodakpharmacy.com.
A Copy of the proposed rules and/or a regulatory analysis may be requested by writing
P O Box 1354 Bismarck ND 58502-1354; emailing ndboph2@btinet.net or calling 701-
328-9535.  Written or oral comments on the proposed rules sent to the above address
or email address and received by January 2, 2012 will be fully considered.
If you plan to attend the public hearing and will need special facilities or assistance
relating to a disability, please contact the ND State Board of Pharmacy at the above
telephone number or address at least two weeks (14 days) prior to the public hearing.
Dated this 11th day of  October  2011.

Ohio: Case Against Elise Miller Who Operated Miller Pharmacy and Three Rivers

March 9, 2012

ELISE MILLER PLAINTIFF-APPELLANT
v.
OHIO STATE BOARD OF PHARMACY DEFENDANT-APPELLEE

Appeal from the Court of Common Pleas, Case No. 2011CI0050

The opinion of the court was delivered by: Farmer, J.

Cite as Miller v. Ohio State Bd. of Pharmacy,

CHARACTER OF PROCEEDING:

JUDGMENT:

DATE OF JUDGMENT:

JUDGES: Hon. Patricia A. Delaney, P.J. Hon. Sheila G. Farmer, J. Hon. John W. Wise, J.

OPINION

Affirmed

{¶1} Appellant, Elise Miller, became a licensed pharmacist in 1979. She owned and operated two pharmacies, Miller Pharmacy which was a retail pharmacy and Three Rivers which provided specialty infusion products. The pharmacies where right next to each other.

{¶2} In 2008, the FBI searched Three Rivers and seized many documents. Three Rivers went bankrupt and was closed by the bankruptcy trustee on April 1, 2009.

{¶3} In April and May of 2009, two investigators from the Ohio State Pharmacy Board, Louis Mandi and David Gallagher, conducted surprise inspections of the pharmacies. Pursuant to a letter from the Board dated March 10, 2010, appellant was charged with 23 counts of misbranding drugs, adulteration of drugs, and failure to keep accurate records. An administrative hearing before the Board was held on December 8, 2010. At the conclusion of the hearing, the Board revoked appellant's pharmacy license. The decision was made an official order on January 14, 2011.

{¶4} On January 28, 2011, appellant filed an appeal with the Court of Common Pleas of Coshocton County. By judgment entry filed June 17, 2011, the trial court affirmed the Board's decision.

{¶5} Appellant filed an appeal and this matter is now before this court for consideration. Assignments of error are as follows:

I

{¶6} "THE TRIAL COURT ERRED IN FAILING TO PROPERLY ADDRESS EACH ASSIGNMENT OF ERROR."

II

{¶7} "THE TRIAL COURT ERRED IN AFFIRMING THE BOARD'S CONCLUSIONS OF LAW, 2, 11, 13, 14 AND 18-24 AS TO WILLFULNESS."

III

{¶8} "THE TRIAL COURT ERRED IN SUMMARILY AFFIRMING THE BOARD'S FINDING NOS. 4, 5, 6 AND 14 AS THERE WAS NO EVIDENCE THAT THESE ITEMS WERE OFFERED FOR SALE AND MS. MILLER HAD ACCESS TO STATE AND FEDERAL DRUG LAWS."

IV

{¶9} "THE TRIAL COURT ERRED IN AFFIRMING THE BOARD'S ADMISSION OF IRRELEVANT HEARSAY EVIDENCE."

V

{¶10} "THE TRIAL COURT ERRED IN SUMMARILY AFFIRMING THE BOARD'S FINDING NO. 12 AS THERE WAS INSUFFICIENT EVIDENCE OF THE DISPENSING OF BACLOFEN AS LIORESAL."

VI

{¶11} "THE TRIAL COURT ERRED IN AFFIRMING THE BOARD'S REFUSAL TO PRODUCE ITS INVESTIGATIVE FILE AND ALL STATEMENTS PRIOR TO THE HEARING."

I

{¶12} Appellant claims the trial court erred in failing to address each of her assignments of error raised in her R.C. Chapter 119 appeal. We disagree.

{¶13} "In reviewing an administrative appeal, the common pleas court is not permitted to either try the issues de novo or substitute its own judgment for that of the administrative agency.***The role of the common pleas court in an administrative appeal is limited to determining whether the judgment of the administrative agency is support by reliable, probative and substantial evidence and is in accordance with law. See R.C. 119.12; see, also, Pons v. Ohio State Med. Bd. (1993), 66 Ohio St.3d 619, 621, 614 N.E.2d 748, 750-751; In re Williams (1991), 60 Ohio St.3d 85, 86, 573 N.E.2d 638, 639." Baughman v. Department of Public Safety Motor Vehicle Salvage (1997), 118 Ohio App.3d 564, 570. (Citations omitted.)

{¶14} "***'Reliable, probative and substantial evidence has been defined as: (1) "Reliable" evidence is dependable; that is, it can be confidently trusted. In order to be reliable, there must be a reasonable probability that the evidence is true. (2) "Probative" evidence is evidence that tends to prove the issue in question; it must be relevant in determining the issue. (3) "Substantial" evidence is evidence with some weight; it must have importance and value. Our Place, Inc. v. Ohio Liquor Control Comm. (1992), 63 Ohio St.3d 570, 571, 589 N.E.2d 1303.' " Vinci v. Ohio State Board of Pharmacy, Tuscarawas App. Nos. 2008 AP 08 0052 and 2008 AP 08 0053, 2010-Ohio-451, ¶85.

{¶15} Appellant argues the trial court is somehow required to follow App.R. 12(A)(1)(c) which states, "[u]nless an assignment of error is made moot by a ruling on another assignment of error, decide each assignment of error and give reasons in writing for its decision." However, trial courts are only required to address the standard of R.C. 119.12. Not only did the trial court sub judice address the evidence as being reliable, probative, and substantial to support the Board's findings, it also addressed evidentiary issues (hearsay) as well as the distinction between Miller Pharmacy and Three Rivers as raised in the appeal.

{¶16} Upon review, we find no necessity for the trial court to follow the Appellant Rules of Procedure.

{¶17} Assignment of Error I is denied.

II, III, V

{¶18} In these assignments, appellant claims the trial court erred in determining the Board's decision was supported by reliable, probative, and substantial evidence. We disagree.

{¶19} Specifically, appellant argues the Board's Findings of Fact Nos. 2, 11, 13, 14, and 18-24 were incorrect because there was no showing of willfulness, Findings of Fact Nos. 4, 5, 6, and 14 were incorrect because there was no showing that the mentioned items were offered for sale, and Findings of Fact No. 12, that she dispensed Baclofen as Lioresal, was not supported by sufficient evidence.

{¶20} " 'On appeal to this Court, the standard of review is more limited. Unlike the court of common pleas, a court of appeals does not determine the weight of the evidence. Rossford Exempted Village School Dist. Bd. of Edn. v. State Bd. of Edn. (1992), 63 Ohio St.3d 705, 707, 590 N.E.2d 1240. In reviewing the trial court's determination [whether] the Board of Review's order was supported by reliable, probative and substantial evidence, this Court's role is limited to determining whether the trial court abused its discretion. Roy v. Ohio State Med. Bd. (1992), 80 Ohio App.3d 675, 680, 610 N.E.2d 562. The term "abuse of discretion" connotes more than an error of law or judgment; it implies that the court's attitude is unreasonable, arbitrary or unconscionable. Blakemore v. Blakemore (1983), 5 Ohio St.3d 217, 219, 450 N.E.2d 1140.' Id. at ¶9, ¶10, 450 N.E.2d 1140. An abuse of discretion shows 'perversity of will, passion, prejudice, partiality, or moral delinquency.' Pons v. Ohio State Med. Bd. (1993), 66 Ohio St.3d 619, 621, 614 N.E.2d 748." Vinci, supra at ¶86.

{¶21} In Payne v. Vance (1921), 103 Ohio St. 59, paragraph three of the syllabus, the Supreme Court of Ohio held, "[w]illful tort involves the element of malice or ill will, but it is not necessary to show actual malice or ill will. It may be shown by indifference to the safety of others after knowledge of their danger, or failure after such knowledge to use ordinary care to avoid injury."

{¶22} Appellant argues no evidence was presented to establish that she willfully dispensed Kineret, a single-use product, into four different syringes, thereby reducing the effectiveness of the drug. See, Findings of Fact Nos. 2 and 11.

{¶23} It is uncontested from appellant's own testimony that she took the commercially packed dosages of Kineret containing 100 mg and repackaged the drug into 25 mg dosages as prescribed by a doctor for a juvenile patient. T. at 61-62. Appellant claimed this had been the practice since 2005 and it was approved by the doctor. T. at 63, 73, 75. However, documented proof of such approval of this method was not presented. Appellant claimed to have no records of the approval or the patient's chart because of the FBI search and confiscation of documents and the subsequent bankruptcy and sale of Three Rivers. T. at 75, 95. Appellant admitted to making dispensing errors. T. at 130, 290.

{¶24} The Board's compliance specialist, Louis Mandi, testified appellant's method was an inappropriate method. T. at 221-222. The single-use dosage can be administered in lesser amounts at the time of injection by injecting the drug into a sterile vial and then the prescribed amount can be removed by a syringe. T. at 222.

Appellant's method compromised the life of the drug from thirty days to four to six hours and exposed it to an unstable environment causing it to congeal or thicken. T. at 221.

{¶25} Appellant disregarded the original packaging and the standard procedures for dispensing the drug and did not have any supporting evidence of approval of her method. We find the trial court did not err in finding this procedure was willful.

{¶26} Appellant argues her failure to have her ID badge on and her failure to have the Drug Laws of Ohio book at hand in Miller Pharmacy was not willful. See, Findings of Fact Nos. 13 and 14. Appellant argued the items were next door at Three Rivers, but also argued she had no control over Three Rivers because the bankruptcy trustee was in control and had shut the place down on April 1, 2009. T. at 267-268. Although technical violations, they were nevertheless violations. These standing alone would not have precipitated the Board's actions, but were part of appellant's "house of cards" when she admitted her life was in chaos. T. at 270.

{¶27} Findings of Fact Nos. 18-24 cover the failure to properly record the dispensing of drugs and keeping patient profiles. Appellant admitted to these errors. T. at 269-272. She attempted to excuse them by arguing her life was in chaos, and she was a small town pharmacist who knew her physicians by voice and first name. T. at 270. She did not state she forgot, she just failed to do it properly. Although all of these claims may very well be true, they are no excuse for failing to comply with the Administrative Code and her own standard of care for her profession.

{¶28} Based upon appellant's admissions and the facts presented via the testimony of compliance specialists Mandi and Gallagher, we find the trial court was correct in concluding there was substantial credible evidence of willfulness.

{¶29} Findings of Fact Nos. 4, 5, and 6 found appellant misbranded drugs. The trial court found these findings were supported by reliable, probative, and substantial evidence. When Mr. Mandi first investigated Three Rivers in April of 2009, he found stored in the refrigerator several unmarked intravenous mixtures and containers that he could not identify. T. at 192-193. There were also unidentified syringes in the refrigerator. T. at 193. The drugs were misbranded because there were no labels on them. T. at 195-196; State's Exhibits 7 and 7a.

{¶30} Appellant was unable to tell Mr. Mandi what was in the containers. T. at 196. Appellant did not deny that they were unmarked, but claimed they were not offered for sale because Three Rivers was closed. T. at 267. This argument is disingenuous because Mr. Mandi and Mr. Gallagher observed activity and persons in Three Rivers at the time of their inspection, and appellant acknowledged compounding drugs there after April 1, 2009. T. at 27, 200-201, 205, 246, 280. We find sufficient evidence of on-going activity and use of Three Rivers after April 2009 to substantiate the fact that unbranded drugs were available for sale.

{¶31} Appellant argues there was insufficient evidence to establish that she was compounding Baclofen and labeling it Lioresal. See, Findings of Fact No. 12. As testified to by Mr. Mandi and admitted by appellant, if the brand drug is available (Lioresal) it is illegal to compound it from the generic (Baclofen) [R.C. 3715.52(A)(2)]. T. at 218-219. While not admitting to compounding Baclofen, appellant admitted it was done for those patients who needed more that the branded amount of 2000 mg; however she was unable to support this claim with prescriptions for those patients she claimed needed more than 2000 mg. T. at 34-35. 37-39, 65.

{¶32} Via the affidavits of Janet Myers who was a technician in the pharmacy in 2008 and Douglas Bolden who was a pharmacist until 2007, there was evidence that appellant oversaw the compounding of Baclofen and labeling it Lioresal. See, Exhibits 3 and 4. Further, Dr. Joseph Poole of the Mt. Vernon Developmental Center provided Mr. Mandi with information that the packaging of Lioresal received from appellant's pharmacy as late as May 13, 2009 was not labeled as the same as the branded Lioresal. T. at 197.

{¶33} Documents compiled by Mr. Mandi compared the purchase versus dispensing records of Lioresal from the pharmacy for 2008-2009. T. at 208-214; Exhibits 34 and 35. Even assuming some overstocking at the commencement of the analysis, the amounts dispensed far exceeded the amounts purchased. T. at 213, 228. This circumstantial evidence plus the direct evidence from Ms. Myers and Mr. Bolden more than substantiated the charge of illegally compounding Baclofen.

{¶34} Assignments of Error II, III, and V are denied.

IV

{¶35} Appellant claims the Board permitted irrelevant hearsay. We disagree.

{¶36} The complained of hearsay testimony consisted of the affidavits of Ms. Myers and Mr. Bolden, statements made by Nurse Busdiecker to Mr. Gallagher, and statements made by Dr. Poole to Mr. Mandi.

{¶37} At the outset, we note the Ohio Rules of Evidence are relaxed in administration proceedings. Simon v. Lake Geauga Printing Co. (1982), 69 Ohio St.2d

41. "Statements that would elsewhere be excluded as hearsay will be admissible in an administrative proceeding where they are not inherently unreliable, and may constitute reliable, probative, and substantial evidence." Vinci, supra at ¶118.

{¶38} Evid.R. 401 defines "relevant evidence" as, "evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence."

{¶39} Each of the complained of statements provide evidence of the illegal compounding of Baclofen to Lioresal; therefore, they were clearly relevant to the issue at hand.

{¶40} Assignment of Error IV is denied. VI

{¶41} Appellant claims she was denied her right to discovery as any criminal defendant would be entitled to to prepare an adequate defense. We disagree.

{¶42} Appellant argues she was entitled to the investigation file that may or may not have included exculpatory evidence.

{¶43} "It is well settled that the Civil Rules pertaining to discovery do not apply to proceedings conducted pursuant to R.C. Chapter 119.12." Baughman, supra at 573; see also Yoder v. Ohio State Board of Education (1988), 40 Ohio App.3d 111. We conclude the same would be the case for the Criminal Rules of Procedure.

{¶44} The Board contends appellant was given every document and a witness list prior to the hearing.

{¶45} Upon review, we find the arguments herein lack merit.

{¶46} Assignment of Error VI is denied.

{¶47} The judgment of the Court of Common Pleas of Coshocton County, Ohio is hereby affirmed.

By Farmer, J.

Delaney, P.J. and Wise, J. concur.

_s/ Sheila G. Farmer_______________ _s/ Patricia A. Delaney_____________ _s/ John W. Wise_________________ JUDGES

[Cite as Miller v. Ohio State Bd. of Pharmacy, 2012-Ohio-1002.]

IN THE COURT OF APPEALS FOR COSHOCTON COUNTY, OHIO FIFTH APPELLATE DISTRICT

ELISE MILLER Plaintiff-Appellant -vs- : OHIO STATE BOARD OF PHARMACY Defendant-Appellee

JUDGMENT ENTRY

CASE NO. 11-CA-9

For the reasons stated in our accompanying Memorandum-Opinion, the judgment of the Court of Common Pleas of Coshocton County, Ohio is affirmed. Costs to appellant.

_s/ Sheila G. Farmer_______________ _s/ Patricia A. Delaney_____________ _s/ John W. Wise_________________ JUDGES

20120309

© 1992-2012 VersusLaw I

Compounding Rules Proposed in Pennsylvania

Pennsylvania has proposed rules that would establish standards for compound of drugs.  See here. Compounding Practices— 49 Pa. Code Chapter 27 (16A-5419)

This proposed rulemaking would establish standards for the compounding of drugs by pharmacists. Statutory Authority: Section 6(k)(9) of the Pharmacy Act, 63 P. S. § 390-6(k)(9) grants the authority to promulgate rules and regulations to effectuate the purposes of the act. Section 2 of the Pharmacy Act, 63 P. S. § 390-2(11) defines the practice of pharmacy to include the compounding of drugs.

California State Board of Pharmacy Proposes Amendments to Compounding Regulations

On February 2, 2012, California's State Board of Pharmacy has proposed Amendments to the Compounding Regulations:

Board Subcommittee to Address the Compounding Regulations

• The Board Proposes Significant Improvements to the Compounding Regulations - After hearing a presentation from Rita Shane, PharmD, FASHP, FCSHP, Director of Pharmacy Services at Cedars-Sinai Medical Center, and many other pharmacists regarding the complications surrounding the current compounding regulations, the board proposed many improvements:
  
  • Expiration Date of Components and Exemption for Hospitals – The board voted in favor of initiating a rulemaking file to amend section 1735.3. as follows:
    1735.3. Recordkeeping of Compounded Drug Products
    (a) For each compounded drug product, the pharmacy records shall include:
    (1) The master formula record.
    (2) The date the drug product was compounded.
    (3) The identity of the pharmacy personnel who compounded the drug product.
    (4) The identity of the pharmacist reviewing the final drug product.
    (5) The quantity of each component used in compounding the drug product.
    (6) The manufacturer, expiration date and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. Exempt from the requirements in this paragraph [(6)] are sterile products compounded on a one-time basis for administration within twenty-fourseventy-two hours stored in accordance with USP standards to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code.
  • Labeling of Chemotherapy and Cytotoxic Substances – The board voted in favor of initiating a rulemaking file to amend section 1751.2(d) to read: “All cytotoxic agents shall bear a special label which states ‘Chemotherapy - Dispose of Properly' or ‘Cytotoxic product – Dispose of Properly.’”
  • Definition of Equipment – The board voted in favor of initiating rulemaking files to amend section 1735.1 to add  a definition of equipment; section 1735.3(a)(7) to remove equipment from the list of items that must be recorded in the daily log when compounding; and 1735.2.(d) to require that the equipment be added to and recorded in the master formulary:
    
    • 1735.1. Compounding
      (a) “Equipment” means items that must be calibrated, maintained or periodically certified
      (ab) “Integrity” means retention of potency until the expiration date noted on the label.
      (bc) “Potency” means active ingredient strength within +/- 10% of the labeled amount.
      (cd) “Quality” means the absence of harmful levels of contaminants, including filth, putrid, or decomposed substances, and absence of active ingredients other than those noted on the label.
      (de) “Strength” means amount of active ingredient per unit of a compounded drug product.
    • 1735.3. Recordkeeping of Compounded Drug Products
      (a) For each compounded drug product, the pharmacy records shall include:
      (1) The master formula record.
      (2) The date the drug product was compounded.
      (3) The identity of the pharmacy personnel who compounded the drug product.
      (4) The identity of the pharmacist reviewing the final drug product.
      (5) The quantity of each component used in compounding the drug product.|
      (6) The manufacturer and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. Exempt from the requirements in this paragraph are sterile products compounded on a one-time basis for administration within twenty-four hours to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code.
      (7) The equipment used in compounding the drug product.
      (87) A pharmacy assigned reference or lot number for the compounded drug product.
      (98) The expiration date of the final compounded drug product.
      (109) The quantity or amount of drug product compounded.
    • (d) A drug product shall not be compounded until the pharmacy has first prepared a written master formula record that includes at least the following elements:
      (1) Active ingredients to be used.
      (2) Inactive ingredients to be used.
      (3) Equipment to be used.
      (34) Process and/or procedure used to prepare the drug.
      (45) Quality reviews required at each step in preparation of the drug.
      (56) Post-compounding process or procedures required, if any.
      (67) Expiration dating requirements.

• The board will hold additional meetings in the future to continue to discuss the compounding regulations. CSHP is also committed to working with the board to create an inpatient compounding guideline that will help address many inconsistencies with the board’s compounding Q&A document. CSHP will continue to work on your behalf at future meetings to ensure the best possible improvements to the compounding regulations.

To view the board materials for this meeting, click here. 

Virginia: Jodi Ettare and Vince Ettare: Rustburg Family Pharmacy and Valley Compounding Pharmacy

State board sets hearing for pharmacist

By: CRAIG DAVISON | The News & Advance 
Published: February 09, 2012

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A Rustburg pharmacist faces an informal hearing before the state Board of Pharmacy next week for possible administrative violations related to the operation of the pharmacy.

Jodi Ettare operates Rustburg Family Pharmacy with her husband, Vince Ettare. The husband-and-wife team of pharmacists also operated Valley Compounding Pharmacy on Timberlake Road in Campbell County, but it closed last fall after Vince Ettare’s license was suspended for a year by the state for violations similar to the allegations Jodi Ettare now faces.

The state Board of Pharmacy found that he left technicians and interns at the pharmacy while he left for other business and that he maintained prescription records saying he was there at the time. The board also found he allowed staff to use the alarm and keys to enter the drug storage area without a pharmacist present, according to the Board of Pharmacy’s order.

A pharmacist is required on the premises at all times and technicians are allowed access to the alarm only under “exceptional” circumstances, said Caroline Juran, executive director of the Board of Pharmacy.

Ettare said it happened because he pushed himself past his limits trying to meet the needs of running a small business. He testified to the board his absence during the periods in question was due to his confidence in his senior pharmacy technician, according to the board’s order.

Losing his license left Jodi Ettare with the responsibility of running the pharmacy.

“Jodi has had to bear the brunt of the burden,” Vince Ettare said.

Jodi Ettare is accused of improperly verifying prescriptions she was not present for and allowing an unlicensed individual to use the alarm code and keys to enter the prescription area, according to the notice for her informal hearing. According to that document, the incidents are alleged to have happened in May and June 2011; Vince Ettare’s license was suspended in August 2011.

The committee at the informal hearing next week can take several actions: dismissal of the charges, probation, a fine, a reprimand or a referral to a formal hearing.

In 2010, the board reprimanded Jodi Ettare for making and dispensing generic Viagra. She signed a consent order that did not admit or deny the accusation.

Valley Compounding opened in January 2008 and Rustburg Family Pharmacy opened about a year later, filling a void in the town after Allied Community Pharmacy closed.

The Ettares' work specializes in compounding medicines, a niche field in pharmacy where chain stores readily dispense premanufactured drugs.

Compounding medications can help make a medication work better for a patient. For example, a person too sick to take pills orally can have the medication compounded into a cream to be rubbed on his or her skin. The couple’s pharmacy also compounds drugs for veterinarians.

Vince Ettare said the stress of keeping two pharmacies open led them to consider consolidating the pharmacies before his suspension. He said it allows them to spend more time with their three children.

“It was something we had considered for a long time,” he said.

Article found here.

Compounding Drugs for Horses

From Equus Magazine

Who Makes the Drugs Your Horse Takes?

By Joseph Rettone, DVM

Where do the drugs that you give your horse come from? Unless you've asked your veterinarian or you've carefully scrutinized the label affixed to the bottle or box, you're probably not aware of the name and location of the firm that manufactured the product. After all, as long as the preparation produces the desired effect to support your horse's health and well-being, it hardly seems essential for you to know much more than how often the drug should be administered and in what amount. Nevertheless, learning just how a pharmaceutical is made and by whom can save you from giving your horse ineffective or even dangerous medications.Compounding drug pharmacies provide a valuable service to the equine community, but it's wise to become familiar with their credentials and procedures.

Brand-name and generic drugs approved by the Food and Drug Administration (FDA) are supplied to veterinarians by the manufacturers, who must comply with strict regulations regarding product safety, efficacy and the manufacturing process. As a result, consumers who use pharmaceuticals that are FDA approved generally are confident of the products' drug content and quality.

In some cases, however, there is no FDA-approved preparation readily available or conveniently formulated to treat a horse--and that's where the services of a compounding pharmacy come in. For example, if a veterinarian wants to administer a particular drug intravenously but only the tablet version has been approved by the FDA, he may ask a compounding pharmacy to produce the medication in intravenous form. In other instances, a compounding pharmacy can make a drug that is not FDA approved in any form. For example, a veterinarian may want to use an antibiotic that is reported to work on a particular infection in laboratory studies but which is not FDA approved for that particular purpose. The compounding pharmacy can use bulk raw chemicals and produce the preparation at the veterinarian's request.

In the absence of stringent government oversight, the use of compounded medications is bounded ethically by several stipulations that include, but are not limited to, the observance of the restrictions that govern the dispensing of prescription drugs, the need for the compounded preparation in the treatment of disease or to improve the welfare of the animal, and the lack of an FDA-approved product in a suitable dosage form to treat the condition.Compounding pharmacies provide an invaluable service because there are not enough FDA-approved drugs to treat all equine diseases. However, the pharmacies that produce compounded drugs are not held to the same standards that the manufacturers of FDA-approved drugs must meet.

Yet, even when these stipulations are satisfied, there is no guarantee that the formulation created by a compounding pharmacy is safe and effective. There are, however, some specific questions your veterinarian can ask to assure that a compounding pharmacy is doing its best for you and your horse.

Does the compounding pharmacy have a licensed pharmacist on staff? Some compounders do not have a pharmacist on staff, or they maintain only a loose association with a pharmacist. Pharmacists have the training, as well as the legal and ethical responsibility, to follow good compounding practices as prescribed by the practice of pharmacy and as outlined by state pharmacy boards. Through their training, pharmacists understand the issues of drug quality, strength, purity and stability, which are essential to the rational use of drugs. Your veterinarian can verify a pharmacist's name and license number with the appropriate state agency.

Are high-quality raw materials used? Obviously, the individual ingredients that go into a drug formulation must be of high quality for the resultant compounded product to be of high quality. When drugs are not FDA approved, there is no assurance that the raw materials are of acceptable quality. Raw materials used by reputable compounding pharmacies are accompanied by a valid certificate of analysis. A reputable compounding pharmacy will not hesitate to provide that information to veterinarians. At the least, a veterinarian can--and should--ask the compounder if the wholesaler of the raw materials is licensed or registered with the state pharmacy board.

What type of quality testing is performed? Ideally, each individual drug preparation would be quality tested before it was shipped to a veterinarian. However, this is impractical in many situations. At a minimum, a compounding pharmacy can test batches of any formulation that is produced regularly. Such analysis will detect any loss of quality of calculation errors.

How stable is the compounded drug? The nature of equine practice leads me to stress the importance of the stability of compounded products. Equine practitioners tend to work outdoors, so the medications that we administer to horses often are kept in uncontrolled climates, which can lead to the breakdown of unstable compounds. The compounding pharmacy should provide some storage instructions with the medication.

To read the rest of the article click here.

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

Story appears at Ocala.com:

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

By Carlos E. Medina
Correspondent

Published: Saturday, June 2, 2012 at 7:16 p.m.

Last Modified: Saturday, June 2, 2012 at 7:16 p.m.

The recent recalls of sterile products made by Franck's Pharmacy in Ocala, as well as its position as a high-volume drug maker, are aspects of the compounding pharmacy business that has troubled federal regulators for years.

The Federal Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight over compounding pharmacies like Franck's because of a 74-year-old law that allows pharmacists to “compound,” or create unique variations of existing drugs for patients.

But that law, and the FDA's lack of authority over the practice of compounding, may draw new scrutiny in the wake of a well-publicized mistake at Franck's that killed two dozen prized polo ponies in 2009 and the production of contaminated solutions that reportedly damaged the vision of 33 eye surgery patients in recent months.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make straight copies of commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether that means creating a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Historically, compounding was the way most people got their prescription medicines. As recently as the 1960s pharmacists routinely ground and mixed compounds in their stores to make the medicines prescribed by local doctors.

The age of mass-produced drugs is a phenomenon of the last fifty years. The availability of those mass-produced drugs eventually led most pharmacies only to dispense ready-made medicines.

To read the rest of the story, click here.

Recent Report Projects that Compounding Pharmacies Will Experience Growth

IBISWorld Inc recently issued the following report:

The Compounding Pharmacies industry is expected to experience annualized revenue growth of 5.5% to $1.8 billion in the five years to 2012. During that time, the industry has benefited from increased awareness of pharmaceutical options among consumers and a growing number of senior citizens. The industry has also gotten a boost from an increasing number of mass manufactured drugs that are in short supply. However, the industry was not entirely unaffected by the recession. Revenue growth slowed during the recession due to a sharp increase in the unemployment rate, which reduced the number of people with private health insurance. Furthermore, the recession hurt per capita disposable income. According to industry analyst Kevin Culbert, “this factor slowed growth because a larger proportion of industry products are paid for out of pocket by consumers compared with traditional pharmaceuticals.”
Luckily for the Compounding Pharmacies industry, there has been no shortage of demand in recent years. In 2012, revenue is expected to grow 7.9%, largely due to a steadily aging US population and an increase in physician visits. In the five years to 2012, the number of adults aged 65 and older is expected to grow 2.4% annually to about 42.7 million people. People aged 65 and older are a major market for this industry because they tend to require more prescription medication than the rest of the population. Consequently, growth in the market has boosted industry demand during the past five years. According to Culbert, “drug shortages can also cause doctors and patients to use compounding pharmacies because operators purchase chemicals in bulk and make medicines on-site.” During the past five years, the number of prescription drug shortages has increased, rising from 61 in 2005 to more than 280 in 2012.
In the five years to 2017, IBISWorld estimates that revenue will increase. During that time, a growing number of doctors and patients will likely turn to compounding pharmacies to prepare medications with alternate doses and strengths. Rising demand will ultimately bring more operators into the industry. IBISWorld projects that the number of firms operating in this industry will increase at an average of 2.3% annually to 178 in the five years to 2017.
For more information visit IBISWorld’s Compounding Pharmacies in the US industry page
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This industry includes stores that make and sell compounded medications. Compounded medications are prescriptions that are written by physicians and prepared by pharmacists for individual patients. These medications are not commercially available; rather, they are prescribed by physicians and prepared by pharmacists to meet unique needs.
IBISWorld industry Report Key Topics