Pages

▼

Friday, February 1, 2013

Updated January 30, 2013

On This Page

NCSL Resources


NCSL Contacts

Quote of Interest

"Federal and Massachusetts officials said Thursday that they lacked clear authority to take action earlier against a now-shuttered specialty pharmacy that set off safety alarms at least six years ago and is now at the center of a burgeoning meningitis outbreak.

"In a teleconference with reporters, the officials described a murky, archaic regulatory apparatus that hampered their ability to keep pace with the rapid changes in compounding pharmacies. That industry, which traditionally has consisted of mom-and-pop operations making customized medicines for individual patients, has expanded to include high-volume pharmacies that rival the production of drug manufacturers."

- Cited in Washington Post, 10/12/2012
In October 2012, national headlines reported a meningitis outbreak of epidemic proportions. The cause was quickly identified as contaminated compounded injectable medication made by a commercial "compounding pharmacy" located in Massachusetts.

Compounding pharmacies are a long-standing yet less frequently discussed element in the complex matrix of prescription drug manufacturing, distribution and patient use. The term refers to any physical pharmacy that is licensed to mix or "compound" chemical ingredients into a finished medication ready to use by an individual patient, based on a prescription ordered by a physician or other legally authorized prescriber.

The federal Food and Drug Administration (FDA) regulates virtually all commercial pharmaceutical manufacturing. However, states are the primary regulator of  pharmacies, including community "drug stores,"  large chains,  in-store pharmacy counters and specialty pharmacies.

State Roles

Every state has laws and regulations guiding pharmacy standards and requirements, addressing issues such as required licenses for each facilty and for the credentialed pharmacists and other employees who work there. Virtually every jurisdiction also has requirements for secure storage, recordkeeping, the forms or pads used for patient prescriptions, labeling, and safety protocols related to origins, authenticity, chain of custody, expiration dates of products, purity, sterility and storage, among others. This includes the extra, explicit authority granted to "compound" or mix pharmaceutical ingredients into a patient-ready product. Numerous existing pharmacies have the authority to prepare such products for patients, based on prescriptions written by doctors or other prescribers. Some of these practice requirements have origins dating back 30 to 50 years, when large drug manufacturers played a much smaller role as the source of medication. State rules are updated periodically, commonly under the jurisdiction of individual state Boards of Pharmacy, which operate in the 50 states.

The Recent Issues

The urgent issues that emerged in late 2012 have an additional emphasis. These include:
  • Compounding or manufacturing: Is it clear which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category?
  • Definitions: Uniform and up-to-date definitions of compounding, wholesale, specialty and hospital-based pharmacies.  Clear language about "sterile" and "non-sterile" compounding.
  • Inspection of facilities: How often, by whom, under what conditions. What kind of independent accreditation or evaluation is in place?
  • Enforcement: Which agencies or boards, state or federal, take action when violations or omissions occur? What levels of penalties are in place? Who can order the closure of an operating pharmacy?
  • Funding: Inspection and enforcement agencies have varied levels of budgets and personnel to complete inspections and enforcement.
  • Transparency: Are records of inspections publicly or adequately available to policymakers and federal and state regulatory entities?
  • Single-use injectibles:  Vials sometimes are over-filled and have no preservative added. The makes costs higher, while repeat injection use by some providers brings additional dangers of contamination and infection.

Table 1 – 2013 Proposed Bills – Compounding Pharmaceuticals (updated January 30, 2013)

StateLaw / Date / Summary / Links Topic
Hawaii
(HI)		 H 61; Introduced, 01/16/2013; 01/18/2013 Subsequent referral set for: HOUSE Committee on CONSUMER PROTECTION AND COMMERCE.
Related to out-of-state pharmacies; Unlawful for any person, as principal or agent, to conduct or engage in the business of preparing, manufacturing, compounding, packing, or repacking any drug without first obtaining a permit from the board to do so.		Compounding; Out-of-state Pharmacies
Massachusetts
(MA)		 H 39; Introduced 1/07/2013; 01/10/2013 To JOINT Committee on PUBLIC HEALTH. At the time of appointment or reappointment to the [pharmacy] board, at least 1 of the 4 registered pharmacist members must have had at least 7 years of experience as a pharmacist engaged in sterile compounding. Section 39E. Sterile Compounding Pharmacy Licensure

The board of registration in pharmacy shall establish a category of pharmacy licensure for pharmacies engaged in the practice of compounding sterile medications that may present an increased potential for harm to the public. The board shall establish in regulation no later than 180 days after passage of this law, the requirements for each category of pharmacy license consistent with pertinent United States Pharmacopeia Standards and General Chapters. All pharmacies licensed pursuant to this section must hold an active license in good standing issued by the board pursuant to sections 39, 39A-C, or 39F of this chapter.

Said board shall determine which regulations, applicable to a retail drug business licensed under section 39 shall apply to a pharmacy registered under this section and may establish regulations which shall apply only to pharmacies engaged in the practice of compounding medications that may present an increased potential for harm to the public. This licensure category should include no fewer than 3 tiered permit categories determined on the basis of volume and type of medication produced. Such permits shall expire on December 31 of each year following the date of its issue, and the fee therefore, shall be determined annually by the commissioner of administration under section 3B of chapter 7.		 Pharmacy Board makeup and establishment of ‘Pharmacy Licensure for Pharmacies Engaged in the Practice of Compounding Sterile Medications’
Mississippi
(MS)		 S 2735; Introduced 01/21/2013; 01/21/2013 To SENATE Committee on PUBLIC HEALTH AND WELFARE.  An Act to amend Mississippi Code of 1972, to define the term nontraditional compounding pharmacy and require all legal entities engaging in this practice to register with the state board of pharmacy; and for related purposes. Definition of nontraditional compounding pharmacy and registration requirement to practice.
New Hampshire
(NH)		 H 313; Introduced 01/03/2013; 01/03/2013 To HOUSE Committee on HEALTH, HUMAN SERVICES AND ELDERLY AFFAIRS.
01/17/2013 Filed as LSR 730.   An Act relative to the regulation of compounding pharmacies.  New language includes: "Compounding" shall not include the reconstitution of powered formulations before dispensing…. Manufacturing shall be governed by Good Manufacturing Practices as adopted and enforced by the federal Food and Drug Administration…..318:14 Pharmacy. A licensed pharmacist shall have the right to conduct a pharmacy for the compounding, according to the provisions of RSA 318:14-a,…….

New Section; Compounding. Amend RSA 318 by inserting after section 14 the following new section:

318:14-a Compounding.

I. Products that are not commercially available may be compounded for hospital or office use but shall not be resold or dispensed. Non-prescription items may be compounded for over-the-counter sale if the labeling complies with state and federal requirements and the product is not a copy of, or similar to, prescription products. All compounding shall be done in compliance with United States Pharmacopeia standards.

II. The compound drug product shall bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration, and the prescription shall be filed at that pharmacy. All compounded prescription labels shall include a statement similar to "This medication was specifically compounded for you at the request of your practitioner."

III. A pharmacist shall offer a compounded drug product to a practitioner for administration to an individual patient, in limited quantities, and without the intention for resale within the medical office or practice of the practitioner. The pharmacist shall maintain records to indicate what compounded drug products were provided to the medical office or practice. Compounding pharmacies may advertise or otherwise promote the fact that they provide prescription compounding services, in accordance with state law and rules of the board, as well as applicable federal laws.

IV. Where a commercial drug shortage exists because a manufacturer is the only entity currently manufacturing a drug product of a specific strength, dosage form, or route of administration for sale in the United States, and the manufacturer cannot supply the drug product to the public or to practitioners for use, a pharmacist may compound using the pure drug product and sell to a patient with a valid prescription from a valid prescriber. When the compounded drug product is sold to a medical office or practice it is for the practitioner to administer to patients, and shall not be for resale or dispensing within the practice.

V. The board shall adopt rules under RSA 541-A concerning the regulation of compounding.

5 Prescription Labels; Reference to Compounding Added. Amend RSA 318:47-a  to read as follows:

318:47-a Prescription Labels. Whenever a pharmacist dispenses a noncontrolled drug pursuant to a prescription, he shall affix to the container in which such drug is dispensed a label showing at least the name and address of the pharmacy and the name or initials of the dispensing pharmacist or pharmacist-in-charge; the prescription identification number assigned by the pharmacy; the date dispensed; any directions as may be stated on the prescription; the name of the prescribing practitioner; the name of the patient; all pertinent auxiliary labels; and, unless otherwise indicated by the prescribing physician, dentist, veterinarian, or advanced practice registered nurse, the name, strength, and quantity of the drug dispensed. All drugs dispensed to a patient that have been filled using a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities. No person shall alter, deface, or remove any label so affixed. A compounded drug product shall also be labeled as provided in RSA 318:14-a. Effective Date. This act shall take effect January 1, 2014.		 Regulation of compounding pharmacies.
Oklahoma
(OK)		 S 522; Prefiled 01/16/2013;

BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:

SECTION 1. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 355.3 of Title 59, unless there is created a duplication in numbering, reads as follows:

As used in this act:

1. "Nonresident pharmacy" means any pharmacy located outside of this state which delivers, dispenses, or distributes by any method prescription drugs or devices to a user physically located in this state, in addition to the initial application or renewal form and other documents required for a pharmacy located in Oklahoma; and

2. "Pharmacist-in-charge" means a professionally competent, legally qualified pharmacist responsible for compliance with all laws and regulations governing the operation of the respective pharmacy.

SECTION 2. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 355.4 of Title 59, unless there is created a duplication in numbering, reads as follows:

A nonresident pharmacy, in addition to the initial application or renewal form and other documents required for a pharmacy located in Oklahoma, shall:

1. Submit an affidavit signed by the pharmacist-in-charge that the pharmacy shall comply with non-sterile and sterile compounding standards of the newest edition of the United States Pharmacopeial and United States Food and Drug Administration Good Manufacturing Practices;

2. a. Submit a pharmacy site inspection form completed and signed within the previous eighteen (18) months by a person authorized by the pharmacy's resident state agency or board which is responsible for issuing pharmacy licenses,

b. Submit a pharmacy site inspection form completed and signed within the previous eighteen (18) months by a staff person employed by the Oklahoma State Board of Pharmacy and pay all costs incurred by the Board for completion of the inspection, or

c. Submit an inspection report or certificate of approval, from an organization approved by the Oklahoma State Board of Pharmacy, which shall include the standards and procedures to which the pharmacy demonstrated compliance; and

3. Pay an additional fee of One Hundred Dollars ($100.00) over and above the licensing and inspection fees charged to in-state pharmacies to cover the additional costs associated with administrative review and consideration of documents listed in subparagraphs a, b and c of paragraph 2 of this section.

SECTION 3. This act shall become effective November 1, 2013.		 Defines non-resident pharmacy, requires the naming of a ‘pharmacist-in-charge,’ requires such pharmacist in charge to submit an affidavit of compliance with requirements of the FDA regarding sterile and non-sterile compounding, additional language on site-inspections and fees.
South Carolina
(SC)		 H 3161; Prefiled 12/18/2012, Introduced 01/08/2013; 01/08/2013 to HOUSE Committee on MEDICAL, MILITARY, PUBLIC AND MUNICIPAL AFFAIRS. TO AMEND SECTION 40-43-30 , CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO DEFINITIONS IN THE SOUTH CAROLINA PHARMACY PRACTICE ACT, SO AS TO DEFINE ADDITIONAL TERMS; TO AMEND SECTION 40-43-86 , RELATING TO COMPOUNDING PHARMACIES, SO AS TO REVISE MINIMUM GOOD COMPOUNDING PRACTICES, TO PROVIDE A PHARMACIST MUST PERFORM A FINAL CHECK ON A PRODUCT COMPOUNDED BY A PHARMACY TECHNICIAN, TO MODIFY REQUIREMENTS FOR AN AREA USED FOR COMPOUNDING IN A PHARMACY, TO PROVIDE PHARMACISTS SHALL ENSURE CERTAIN EXPECTED FEATURES OF INGREDIENTS USED IN A FORMULATION, TO PROVIDE A MEANS FOR DETERMINING THE MAXIMUM BEYOND-USE DATE OF AN EXCESS AMOUNT OF A SPECIFIC COMPOUND IN CERTAIN CIRCUMSTANCES, TO REQUIRE CERTAIN WRITTEN POLICIES AND PROCEDURES APPLICABLE TO A COMPOUNDING AREA, AND TO PROVIDE THAT MATERIAL DATA SAFETY MUST BE READILY ACCESSIBLE TO PHARMACY PERSONNEL WHO WORK WITH DRUG SUBSTANCES OR BULK CHEMICALS, AND TO DELETE OBSOLETE LANGUAGE; AND TO AMEND SECTION 40-43-88 , RELATING TO THE HANDLING OF STERILE PRODUCTS BY PHARMACIES, SO AS TO REVISE ASSOCIATED STANDARDS AND TO BROADEN THE APPLICATION OF THESE STANDARDS TO INCLUDE OTHER FACILITIES PERMITTED BY THE BOARD, AMONG OTHER THINGS. Defines aseptic preparation; automated compounding device; ANTE area; beyond use date; buffer area; certified pharmacy technician; closed-system transfer device; colony forming unit; compounding sterile preparation; etc.
S 183; Introduced 01/08/2013; 01/08/2013 to SENATE Committee on MEDICAL AFFAIRS. TO AMEND SECTION 40-43-30 , CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO DEFINITIONS IN THE SOUTH CAROLINA PHARMACY PRACTICE ACT, SO AS TO DEFINE ADDITIONAL TERMS; TO AMEND SECTION 40-43-86 , RELATING TO COMPOUNDING PHARMACIES, SO AS TO REVISE MINIMUM GOOD COMPOUNDING PRACTICES, TO PROVIDE A PHARMACIST MUST PERFORM A FINAL CHECK ON A PRODUCT COMPOUNDED BY A PHARMACY TECHNICIAN, TO MODIFY REQUIREMENTS FOR AN AREA USED FOR COMPOUNDING IN A PHARMACY, TO PROVIDE PHARMACISTS SHALL ENSURE CERTAIN EXPECTED FEATURES OF INGREDIENTS USED IN A FORMULATION, TO PROVIDE A MEANS FOR DETERMINING THE MAXIMUM BEYOND-USE DATE OF AN EXCESS AMOUNT OF A SPECIFIC COMPOUND IN CERTAIN CIRCUMSTANCES, TO REQUIRE CERTAIN WRITTEN POLICIES AND PROCEDURES APPLICABLE TO A COMPOUNDING AREA, AND TO PROVIDE THAT MATERIAL DATA SAFETY MUST BE READILY ACCESSIBLE TO PHARMACY PERSONNEL WHO WORK WITH DRUG SUBSTANCES OR BULK CHEMICALS, AND TO DELETE OBSOLETE LANGUAGE; AND TO AMEND SECTION 40-43-88 , RELATING TO THE HANDLING OF STERILE PRODUCTS BY PHARMACIES, SO AS TO REVISE ASSOCIATED STANDARDS AND TO BROADEN THE APPLICATION OF THESE STANDARDS TO INCLUDE OTHER FACILITIES PERMITTED BY THE BOARD, AMONG OTHER THINGS. Similar to H 3161- please see above.
Utah
(UT)		 S 14; Prefiled 12/20/2012; Introduced 01/28/2013; 01/28/2013 To SENATE Committee on RULES; 01/28/2013 From SENATE Committee on RULES. (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a retail pharmacy to compound or dispense a drug or dispense a device to the public under a prescription order….(18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a limited quantity drug, sterile product, or device: (i) as the result of a practitioner's prescription order or initiative based on the practitioner, patient, or pharmacist relationship in the course of professional practice; (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing; or (iii) in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.  (b) "Compounding" does not include: (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to another pharmacist or pharmaceutical facility; (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a dosage form which is regularly and commonly available from a manufacturer in quantities and strengths prescribed by a practitioner; or (iii) the preparation of a prescription drug, sterile product, or device which has been withdrawn from the market for safety reasons……(b) "Manufacturing" includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons. (c) "Manufacturing" does not include the preparation or compounding of a drug by a pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation, compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical analysis……(47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility engaged in the business of wholesale vending or selling of any prescription drug or device to other than the consumer or user of the prescription drug or device, which the pharmaceutical facility has not produced, manufactured, compounded, or dispensed…...(56) "Practice of pharmacy" includes the following: (c) compounding, packaging, labeling, dispensing, administering, and the coincident distribution of prescription drugs or devices. Pharmacy Practice Act; includes compounding-related definitions.
Virginia
(VA)		 H 2181; Introduced 01/09/2013; 01/28/2013 To SENATE Committee on EDUCATION AND HEALTH. "Compounding" means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed prescribing patterns; (ii) by or for a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer's product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (§ 54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or A 19 of § 54.1-2901, or a person supervised by such practitioner or a licensed nurse practitioner or physician assistant pursuant to subdivision A 4 of § 54.1-2901 shall not be considered compounding………."Dispense" means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for that delivery. However, dispensing shall not include the transportation of drugs mixed, diluted, or reconstituted in accordance with this chapter to other sites operated by such practitioner or that practitioner's medical practice for the purpose of administration of such drugs to patients of the practitioner or that practitioner's medical practice at such other sites. For practitioners of medicine or osteopathy, "dispense" shall only include the provision of drugs by a practitioner to patients to take with them away from the practitioner's place of practice….."Proprietary medicine" means a completely compounded nonprescription drug in its unbroken, original package which does not contain any controlled substance or marijuana as defined in this chapter and is not in itself poisonous, and which is sold, offered, promoted or advertised directly to the general public by or under the authority of the manufacturer or primary distributor, under a trademark, trade name or other trade symbol privately owned, and the labeling of which conforms to the requirements of this chapter and applicable federal law. However, this definition shall not include a drug which is only advertised or promoted professionally to licensed practitioners, a narcotic or drug containing a narcotic, a drug which may be dispensed only upon prescription or the label of which bears substantially the statement "Warning - may be habit-forming," or a drug intended for injection. Medical equipment suppliers; includes compounding-related definitions.
H 2312; Introduced 01/18/2013; 01/29/2013 From HOUSE Committee on HEALTH, WELFARE AND INSTITUTIONS: Reported Favorably.

§ 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 in  accordance 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, (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; or 3. The compounding of inordinate amounts of any preparation in cases in which there is no observed historical pattern of prescriptions and dispensing to support an expectation of receiving a valid prescription for the preparation. The compounding of an inordinate amount of a preparation in such cases shall constitute manufacturing of drugs. 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. § 54.1-3434.1. Nonresident pharmacies to register with Board. A. Any pharmacy located outside the Commonwealth that ships, mails, or delivers, in any manner, Schedule II through VI drugs or devices pursuant to a prescription into the Commonwealth shall be considered a nonresident pharmacy, shall be registered with the Board, shall designate a pharmacist in charge who is licensed as a pharmacist in Virginia and is responsible for the pharmacy's compliance
 with this chapter, and shall disclose to the Board all of the following: 1. The location, names, and titles of all principal corporate officers and the name and Virginia license number of the designated pharmacist in charge, if applicable. A report containing this information shall be made on an annual basis and within 30 days after any change of office, corporate officer, or pharmacist in charge. 2. That it maintains, at all times, a current unrestricted license, permit, certificate, or registration to conduct the pharmacy in compliance with the laws of the jurisdiction, within the United States or within another jurisdiction that may lawfully deliver prescription drugs directly or indirectly to consumers within the United States, in which it is a resident. The pharmacy shall also certify that it complies with all lawful directions and requests for information from the regulatory or licensing agency of the jurisdiction in which it is licensed as well as with all requests for information made by the Board pursuant to this section. 3. As a prerequisite to registering or renewing a registration with the Board, the nonresident pharmacy shall submit a copy of the most recent a current inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located that indicates compliance with the requirements of this chapter, including compliance with USP-NF standards for pharmacies performing sterile and non-sterile compounding. The inspection report shall be deemed current for the purpose of this subdivision if the inspection was conducted within the past five years (i) no more than six months prior to the date of submission of an application for registration with the Board or (ii) no more than two years prior to the date of submission of an application for renewal of a registration with the Board. However, if the nonresident pharmacy has not been inspected by the regulatory or licensing agency of the jurisdiction in which it is licensed within the past five years required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection. 4. For a nonresident pharmacy that dispenses more than 50 percent of its total prescription volume pursuant to an original prescription order received as a result of solicitation on the Internet, including the solicitation by electronic mail, that it is credentialed and has been inspected and that it has received certification from the National Association of Boards of Pharmacy that it is a Verified Internet Pharmacy Practice Site, or has received certification from a substantially similar program approved by the Board. The Board may, in its discretion, waive the requirements of this subdivision for a nonresident pharmacy that only does business within the Commonwealth in limited transactions. 5. That it maintains its records of prescription drugs or dangerous drugs or devices dispensed to patients in the Commonwealth so that the records are readily retrievable from the records of other drugs dispensed and provides a copy or report of such dispensing records to the Board, its authorized agents, or any agent designated by the Superintendent of the Department of State Police upon request within seven days of receipt of a request. 6. That its pharmacists do not knowingly fill or dispense a prescription for a patient in Virginia in violation of § 54.1-3303 and that it has informed its pharmacists that a pharmacist who dispenses a prescription that he knows or should have known was not written pursuant to a bona fide practitioner-patient relationship is guilty of unlawful distribution of a controlled substance in violation of § 18.2-248. 7. That it maintains a continuous quality improvement program as required of resident pharmacies, pursuant to § 54.1-3434.03. The requirement that a nonresident pharmacy have a Virginia licensed pharmacist in charge shall not apply to a registered nonresident pharmacy that provides services as a pharmacy benefits administrator. B. Any pharmacy subject to this section shall, during its regular hours of operation, but not less than six days per week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in the Commonwealth and a pharmacist at the pharmacy who has access to the patient's records. This toll-free number shall be disclosed on a label affixed to each container of drugs dispensed to patients in the Commonwealth. C. Pharmacies subject to this section shall comply with the reporting requirements of the Prescription Monitoring Program as set forth in § 54.1-2521. D. The registration fee shall be the fee specified for pharmacies within Virginia. E. A nonresident pharmacy shall only deliver controlled substances that are dispensed pursuant to a prescription, directly to the consumer or his designated agent, or directly to a pharmacy located in Virginia pursuant to regulations of the Board. § 54.1-3434.2. Permit to be issued. The Board shall only register nonresident pharmacies that maintain a current unrestricted license, certificate, permit, or registration as a pharmacy in a jurisdiction within the United States, or within another jurisdiction that may lawfully deliver prescription drugs directly or indirectly to consumers within the United States. Applications for a nonresident pharmacy registration, under this section, shall be made on a form furnished by the Board. The Board may require such information as it deems is necessary to carry out the purpose of the section. The permit or nonresident pharmacy registration shall be renewed annually on a date determined by the Board in regulation. Renewal is contingent upon the nonresident pharmacy providing documentation of a current inspection report in accordance with subdivision A 3 of § 54.1-3434.1; continuing current, unrestricted licensure in the resident jurisdiction; and continuing certification if required in subdivision A 4 of § 54.1-3434.1.		Compounding pharmacies: A BILL to amend and reenact §§ 54.1-2408.1, 54.1-3401, 54.1-3410.2, 54.1-3434.1, and 54.1-3434.2 of
4 the Code of Virginia, relating to compounding pharmacies.

Similar to H 2182 prior to specific compounding language; please see above.


Resources:
 

Federal and National Standards for Pharmacies and Pharmacists

For pharmacies and pharmacists who engage in compounding, many states require that all "actions be performed in accordance with United States Pharmacopeia (USP) Standards."  The two key standards are termed as follows: USP Standard <Section 795> addresses the practice for Non-Sterile Compounding and USP Standard <Section 797> addresses the practice for Sterile Compounding Preparations. Current state data is noted in the table below.**
The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements. The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

FDA Meeting and Actions, 2012-13NEW icon
On Dec. 19, 2012, FDA Commissioner Margaret Hamburg convened a meeting of state regulators from the 50 states and the District of Columbia and other key stakeholders to discuss the issues surrounding the NECC events, and to discuss the future course of compounding pharmacy regulation.  FDA Commissioner Hamburg favors the formation of a three-tiered classification system for compounding pharmacies: (1) traditional; (2) nontraditional compounding pharmacy; or (3) manufacturer. Dr. Hamburg supports a process by which states partner with FDA in the regulation of the non-traditional pharmacies. Members of Congress are concerned about the regulatory vacuum with respect to the non-traditional compounding pharmacies, but seem to be equally concerned about the adequacy of state regulation of compounding pharmacies in a more general sense.  During the last Congress, Commissioner Hamburg testified before the House Committee on Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee.  Senators Harkin (D-IA) and Enzi (R-WY), the chairman and ranking member respectively, sent a survey to each state pharmacy board to gather information about state regulatory practices related to compounding pharmacies to help the Senate committee prepare to draft legislation during the 113th Congress.  The FDA has detailed one of its most senior staff people to oversee the FDA’s work on this issue.  Moving forward,FDA officials urged state legislators to examine current practices in their states regarding the regulation of compounding pharmacies and to be prepared to participate in discussions with federal officials on the best way to move forward in a way that allows state regulation of compounding pharmacies and also protects the public as the compounding pharmacy industry evolves.  [Source: NCSL Federal Health Pulse, January 21, 2013]

Overview and Examples of State Laws and Actions

The following are a few examples of state actions:
  • In 2011-2012 at least 16 states enacted laws affecting the practices of compounding pharmacies.  A new table, 2011-2012 Compounding Pharmacies-related Enacted Legislation of these measures, Alabama, Colorado, Indiana, Kansas, Kentucky, Michigan, Minnesota, Nebraska, New Jersey, Ohio, Oklahoma, Rhode Island, Utah, Virginia,Washington and West Virginia,  is included below
  • The Missouri Board of Pharmacy in 2006 began randomly sampling compounded drugs, "after a pharmacist in Kansas City, Mo., pleaded guilty to watering down chemotherapy drugs.  In 2008, one in four samples failed a potency test. The failure rate dropped to 15 percent in 2010, the most recent year available."
  • The Texas State Board of Pharmacy started its own random testing program after examining what Missouri had put in place. “If you take a drug, you should expect to get the amount of drug listed on the bottle,” said Gay Dodson, the Texas board’s executive director.  In April 2012, a compounding pharmacy in Dallas, ApotheCure Inc., and its owner, pleaded guilty in federal court to two misdemeanors for shipping a misbranded drug that led to the deaths of three people in the Pacific Northwest. Subsequent testing by the F.D.A. found that some vials were superpotent, containing 640 percent of the drug listed on the label, while others were subpotent."
  • Six states (Arizona, California, Missouri, New York, North Carolina and Rhode Island) had “state enforcement records related to the safety of compounding pharmacy practices" publicly available with state enforcement records according to the survey published by Rep. Edward Markey’s staff. The other 44 states had varying practices.
  • Massachusetts 2013 Legislation, H.39 was filed by the Governor in early January.  The bill would establish stricter state licensing requirements for compounding sterile drugs; authorize state imposed fines against pharmacy violations; provide whistle-blower protection for pharmacy workers who report abuses and restructure the state board of pharmacy to include more independent, non-industry members.
  • The Massachusetts Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department has taken several actions in the wake of discovering that the large-scale compounding pharmacy, New England Compounding Center, now closed, was identified as shipping large quantities of contaminated or non-sterile injectable drugs.  Those Massachusetts-originated drugs have been shown to be used byan estimated 14,000 patients in more than 20 states.  In late October, state officials moved to order three compounding pharmacies to cease work. Infusion Resource voluntarily surrendered its license on October 27.  The third company, Ameridose, has ceased distribution.  State inspectors who visited Infusion Resource found “significant issues with the environment in which medications were being compounded.”  Gov. Deval Patrick also directed the state’s Board of Registration in Pharmacy to start unannounced inspections immediately of compounding pharmacies that prepare sterile, injectable medications. There are 25 such pharmacies in Massachusetts; Gov. Patrick has acknowledged that the state rules governing them were insufficient.
Compounding Pharmacies in the News

Existing state laws and regulations as of Dec. 2012

Note that these provisions may not be the only regulations affecting a given pharmaceutical facility--other licensing and inspection provisions may also apply.  The National Association of Boards of Pharmacy (NABP) is the nationwide authority that records and facilitates the work of the individual state Boards of Pharmacy, established by law in virtually every state and territory. NCSL consulted the NABP "Minimum Standards of Practice" survey in the compilation of this state law and regulation table. To view or order NABP legal products, visit NABPLaw Online.
KEY:  "Sterile Preparations, USP" refers to existing state regulations of in-state compounding pharmacies, requiring  that all "actions be performed in accordance with United States Pharmacopeia (USP) Standards."
"PCAB Accreditation" indicates the number of in-state compounding pharmacies that are listed as approved by the "Pharmacy Compounding Accreditation Board,"a voluntary quality accreditation designation for the compounding industry." Nationwide 163 facilities have this accreditation.  This list provides the names and locations of accredited pharmacies.


Source found here

 

-

No comments:

Post a Comment