Texas State Board of Pharmacy Proposed Amendments

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that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.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

Summary of FDA bill passed by Congress

Summary of FDA bill passed by Congress

Associated Press – Tue, Jun 26, 2012

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

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

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

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

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

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

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

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

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

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

House sends FDA fee bill to Senate for final vote

The Associated Press

Wednesday, June 20, 2012 | 1:09 p.m.

The House on Wednesday passed a major bill affecting the Food and Drug Administration that will increase inspections of drug manufacturing facilities overseas, while also funding review of new drugs at home.

Under the bill, approved by majority voice vote Wednesday, the FDA will have more flexibility to inspect sites in China, India and other countries. The number of U.S. drugs produced overseas has more than doubled over the last decade.

The underlying legislation renews an agreement under which drug companies pay the FDA to review new products. The FDA will collect $6.4 billion in fees from companies over the next five years. For the first time, the agency will collect fees from generic drugmakers to speed up approvals of their therapies. The FDA currently has a backlog of roughly 2,700 generic drugs awaiting review.

Other sections of the bill increase fines for drug counterfeiting and require drugmakers to notify the government earlier of potential drug shortages. More than 280 drugs are currently in short supply in the U.S., due in part to drug industry consolidation.

The bill sorts out differences in prior legislation passed by the House and Senate. House lawmakers approved their initial version of the sweeping legislation last month in a 387-5 vote.

The Senate is expected to vote on the bill next week, after which it will go to White House to be signed into law.

The National Association of Pharmacy Boards' 2011-2012 Report of the Committee on Law Enforcement/Legislation Released

The National Association of Pharmacy Boards website contains the following:

2011-2012 Report of the Committee on Law Enforcement/Legislation Released

June 04, 2012 10:11 AM

The Committee on Law Enforcement/Legislation met February 29, 2012.
Committee members reviewed their charge and accepted it as follows:

1. Review and comment on existing legislation and rules for the practice of pharmacy, legal distribution of drugs, and related areas within pharmacy, including impaired pharmacists.
2. Develop model regulations for pharmacy as assigned by the Executive Committee, or from resolutions adopted by the members of the Association, or from reports of the other committees of the Association.
3. Recommend to the Executive Committee areas where model regulations are needed in pharmacy for improving the protection of the public health.

View the committee's recommendations in the full report (PDF).

Congress fails to agree on national drug trace plan

Congress fails to agree on national drug trace plan
By Anna YukhananovWASHINGTON | Mon Jun 18, 2012 5:45pm EDT

(Reuters) - Lawmakers failed to agree on a national plan for tracking medications, congressional staffers said on Monday, crimping efforts to protect the U.S. supply chain from the threat of counterfeit or stolen drugs.

After a last-ditch weekend attempt to hammer out the details of a plan, the Senate and House of Representatives conceded defeat in trying to include the measure in a "must-pass" funding bill for the U.S. Food and Drug Administration (FDA), said the staffers, who spoke on condition of anonymity.

The FDA funding bill is likely to be submitted for approval to President Barack Obama in early July, House leaders have said.
"But the timeline was very long. ... It was just unclear that (individual tracking) would ever actually happen." it through a divided Congress.

Earlier this year, counterfeit vials of cancer drug Avastin were sold to dozens of medical practices across the country, sparking new fears about the safety of the drug supply.

Regulators and healthcare companies have been talking about a "track and trace" system for nearly a decade, but cannot agree on what the system will look like or who will pay for it.

"It's disappointing," said one staffer, who was not authorized to speak on the record.

The staffer said some lawmakers may try to introduce the measure as a stand-alone bill later this year. But the legislation may have a hard time making it. The Senate version of the FDA bill included room for a law that would require a uniform drug tracing system, based on an amendment proposed by Senators Richard Burr, a Republican from North Carolina, and Michael Bennet, a Democrat from Colorado.

But after a new draft was proposed late on Friday, lawmakers could not get all sides to agree on how quickly the United States would move toward a "unit level" system that tracks individual drug packages.

"The draft recognized for the first time that we do need to eventually get to unit-level tracking," said Allan Coukell, director of medical programs at the Pew Health Group, which has been involved developing the legislation.In the meantime, companies may have to start complying with at least one state's laws on the issue. California passed its own law for a track and trace system in 2004.

While healthcare companies were able to delay its implementation three times, the plan is now scheduled to begin in 2015.

Virginia Herold, executive officer of the California Board of Pharmacy, said she supports a national drug tracing system, rather than a patchwork of separate state rules. But the Congressional draft system would take at least 10 years to create a truly secure system, she said.

"We know there are problems in the supply chain," she said. "We need something to sort it out before we have a major public health event."

The FDA has been pushing for a uniform plan that would track individual vials of medicine. But companies, distributors and pharmacies say it may be too expensive, and propose an alternative plan that would track much larger "lots" of drugs. They say their plan would pave the way for more stringent rules later.

Article is found here.

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.