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regulating compounding pharmacies

State Regulation of Compounding Pharmacies

6/6/2014

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 facility 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 injectables:  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.

2014 Resources

Florida passed a new law applicable to compounding pharmacies. CS/HB 7077: Nonresident Sterile Compounding Permits was enacted June 13, 2014, and will become effective October 1st. The law refers to permitting and inspection requirements for nonresident sterile compounding pharmacies. The law also enhances penalties and applies certain "health care fraud provisions" to such pharmacies. Read the full text of the law here.

New Report Examines Updates to Compounding Pharmacy Law - An NCSL Blog post of June 6, 2014 informs members of NCSL's collaboration with the Pew Charitable Trusts which has commissioned an independent report, "Quality Standards for Large Scale Sterile Compounding Facilities." The report, by Clinical IQ, provides an updated road map, it chronicles the dramatic changes in drug compounding over recent decades and describes quality measures needed to ensure safety when compounding occurs on a commercial scale.

As detailed in the report, although traditional compounding is primarily regulated by the states, not all compounders under state oversight are operating in a traditional manner—preparing custom medicines for individual patients. Today, many states reference quality standards set by the United States Pharmacopeia for safe sterile drug compounding (widely cited as “USP Chapter <797>”). But the report points out that this standard was created for traditional compounding activities, and maintains it is not sufficient for high-volume operations. The report encourages the USP to update <797>—currently under revision—to reflect compounding at different scales. In the meantime, states continue to face decisions about oversight.

NCSL Meeting Session | Fall Forum, Dec. 6, 2013

Tracking Tracing and Compounding: An Update on Pharmaceutical Legislation
  • Jane Axelrad, Food and Drug Administration (FDA) - View slidesPresentation 
  • I. Bernstein, Food and Drug Administration >FDA)- View slides: Presentation 
  • Elizabeth "Scotti" Russell, Government Affairs Manager, National Association of Boards of Pharmacy (NABP), Illinois - View slides: Presentation

"Compounding Interest" - NCSL feature article in State Legislatures magazine, June 2013.

The Pew Charitable Trusts commissioned a report entitled Quality Standards for Large Scale Sterile Compounding Facilities. The report, released May 2014 and is publicly available online, provides an updated roadmap: it chronicles the dramatic changes in drug compounding over recent decades and describes quality measures needed to ensure safety when compounding occurs on a commercial scale.

Congressional Report: "State of Disarray" Compounding Pharmacies Going Untracked, Unregulated, Under-inspected from Coast to Coast - a survey of states, released April 15, 2013 |  Full report is available - More. (41 pp, PDF) 
 

(updated Oct. 15, 2013) 

In 2013, a total of 27 bills or resolutions were filed across 16 states which relate to compounding pharmacies.  Of the 25 bills or resolutions posed, 10 have been adopted or enacted into law.
 
2013 Enacted Compounding Pharmacies | Related Laws
State and Bill No Title Summary
CA S 294 Sterile Drug Products Enacted as Chapter No. 565, 10/4/2013.  Prohibits a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the Board of Pharmacy. Specifies requirements for the issuance or renewal of a license, and requirements for the pharmacy as a licensee.  
GA H 209 Provisions For Pharmacists Relates to pharmacists and pharmacies, provides for license transfers for pharmacists licensed in another jurisdiction, relates to dispensing prescription drugs, use of security paper for hard copy prescription drug orders, compounding drug products, nonresident pharmacy permits and the electronic data base of prescription information, revises the definition of a dispenser relative to information to include for each Schedule II, III, IV, or V controlled substance prescription.
MD H 986 Pharmacy Sterile Compounding Permits Requires a sterile compounding facility to hold a sterile compounding permit issued by the State Board of Pharmacy before the sterile compounding facility may perform sterile compounding in the State, provides that a sterile compounding permit is required in addition to and does not replace other permits or licenses, provides that a person that prepares and distributes sterile drug products into or within the State is not required to hold a sterile compounding permit but shall hold certain other permits.

MA

[Not yet law]

Regulating compounding by pharmacists [[Still in Conference Comm., 11/27/2013]]
Relates to pharmacy practice in the Commonwealth; provides for a board of registration in pharmacy; provides for licensing and labeling requirements regarding sterile or non-sterile compounded drug preparation, serious adverse drug events, event reporting requirements and the marketing code of conduct. 
MN H 1233 Redefining Redefining research drugs, by adding: (3) dispensing and distribution of research drugs by pharmacies shall not be considered compounding, manufacturing, or wholesaling under this chapter.
NH H313
 
Regulating compounding by pharmacists Chapter No. 2013-0121, signed 6/25/2013. Provides for regulation of the compounding of drugs by pharmacists; provides that a licensed pharmacist shall have the right to conduct a pharmacy for the compounding of medicines upon physicians', dentists' and physician assistants' prescriptions or a valid order for the sale, and distribution of drugs; requires that the compound drug product bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration.
TN S 582 Pharmacy Practice Act Relates to Pharmacy, revises the definition of compounding to include the preparation, mixing, assembling, packaging or labeling of a drug or device for use in a practitioner's office, medical facility, by emergency medical services or a licensed veterinarian for administration to the prescribing practitioner's patients when the product is not commercially available, provides for licensure and inspection of out of state pharmacies, exempts hospital compounding pharmacies from specified reporting.
TX S 1100 Licensing and Inspection Relates to the licensing and inspection of out-of-state pharmacies by the Texas State Board of Pharmacy, authorizes fees.
U H 200 Utah Code Revisions (d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to patients is reconstituted or compounded. Modifies parts of the Utah Code to make technical corrections, including eliminating references to repealed provisions, making minor wording changes, updating cross references, and correcting numbering, modifies parts of the Utah Code to make technical corrections, including eliminating references to repealed provisions, making minor wording changes, updating cross references, correcting numbering, and fixing errors that were created from the previous year's session.
UT S 14 Pharmacy Practice Act Pharmacy Practice Act. Amends the Pharmacy Practice Act, defines research using pharmaceuticals, exempts research using pharmaceuticals from licensure to engage in the practice of pharmacy, telepharmacy, or the practice of a pharmacy technician, exempts research using pharmaceuticals from licensure to act as a pharmacy, makes technical corrections.
VA H 2312 (2012) Compounding Pharmacies Relates to compounding pharmacies, clarifies the definition of compounding and adds a requirement for a current inspection report for registration or renewal of a registration for a nonresident pharmacy, provides that the compounding of an inordinate amount of a preparation where there is not historical pattern of prescriptions to support an expectation of receiving a valid prescription for the preparation shall constitute manufacturing of drugs.


 

2013 Proposed Compounding Pharmacies - Related Legislation
STATE & BILL No. TITLE CURRENT DISPOSITION SUMMARY
CA S 294 Sterile Drug Products 10/04/2013 Enacted as Chapter No. 565 Prohibits a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the Board of Pharmacy. Specifies requirements for the issuance or renewal of a license, and requirements for the pharmacy as a licensee.
GA H 209 Provisions For Pharmacists Enacted Relates to pharmacists and pharmacies, provides for license transfers for pharmacists licensed in another jurisdiction, relates to dispensing prescription drugs, use of security paper for hard copy prescription drug orders, compounding drug products, nonresident pharmacy permits and the electronic data base of prescription information, revises the definition of a dispenser relative to information to include for each Schedule II, III, IV, or V controlled substance prescription.
HI H 61 Out of State Pharmacy Pending - Carryover Requires an out-of-state pharmacy delivering drugs into the State to have in its employ a pharmacist licensed under chapter 461, HRS.
MA H 39 Pharmacy Practice Pending Relates to pharmacy practice in the Commonwealth.
MA S 1 Governor State of the Commonwealth Pending Submits a message from the Governor relative to the general concerns of the Commonwealth.
MA
S 1053
H 3672
Pharmacies NEW iconPassed Senate; passed House;
in Conference Comm., 11/27/13
Relates to pharmacy practice in the Commonwealth; provides for a board of registration in pharmacy; provides for licensing and labeling requirements regarding sterile or non-sterile compounded drug preparation, serious adverse drug events, event reporting requirements and the marketing code of conduct. 
MD H 986 Pharmacy Sterile Compounding Permits Enacted Requires a sterile compounding facility to hold a sterile compounding permit issued by the State Board of Pharmacy before the sterile compounding facility may perform sterile compounding in the State, provides that a sterile compounding permit is required in addition to and does not replace other permits or licenses, provides that a person that prepares and distributes sterile drug products into or within the State is not required to hold a sterile compounding permit but shall hold certain other permits.
MD S 896 State Board of Pharmacy Failed - Adjourned Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits.
ME H 934 Safety of Compounded Drugs To Governor; Vetoed & sustained; bill failed 6/26/2013 Strengthens Maine's laws on compounding pharmacies. The bill contains the following provisions. 1. The bill provides a definition for "compounding pharmacy" and describes sterile compounding pharmacies and non sterile compounding pharmacies. 2. Beginning with appointments made on or after January 1, 2014, the bill adds a physician and an advanced practice registered nurse to the Maine Board of Pharmacy, decreases the number of pharmacist members from 5 to 3.
MN H 1136 Pharmacy Regulation Pending - Carryover Changes licensing requirements for pharmacies, drug manufacturers, and wholesale drug distributors, requires all licensed pharmacies to comply with federal laws and state laws and rules related to operation of a pharmacy, requires out-of-state pharmacies dispensing drugs to residents of Minnesota to comply with federal laws related to operation of a pharmacy.
MN H 1208 Health Pending - Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program.
MN S 1081 Health Pending - Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program.
MS S 2735 State Board of Pharmacy Registration Failed Defines the term non-traditional compounding pharmacy and require all legal entities engaging in this practice to register with the state board of pharmacy.
NM H 313 Regulation of the Compounding of Drugs by Pharmacists To Governor Provides for regulation of the compounding of drugs by pharmacists, provides that a licensed pharmacist shall have the right to conduct a pharmacy for the compounding of medicines upon physicians', dentists' and physician assistants' prescriptions or valid order for the sale, and distribution of drugs, requires that the compound drug product bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration.
NJ A 3453 (2012) Compounding Pharmacy Quality Assurance Act Pending Enacts the Compounding Pharmacy Quality Assurance Act, requires accreditation of compounding pharmacies.
NJ S 2365 (2012) Compounding Pharmacy Quality Assurance Act Pending Creates the Compounding Pharmacy Quality Assurance Act, requires accreditation of compounding pharmacies.
OK S 522 Nonresident Pharmacies Pending - Carryover Relates to professions and occupations, imposes requirements on nonresident pharmacy, imposes a fee to cover the additional costs associated with administrative review and consideration of certain documents, requires a pharmacy site inspection form, requires licensure of certain persons, requires prescription for Plan B One-step, or its generic equivalent, also known as the "morning-after" emergency contraceptive administered to minors, provides for codification, provides an effective date.
SC H 3161 South Carolina Pharmacy Practice Act Pending Relates to definitions in the South Carolina Pharmacy Practice Act , defines additional terms, relates to compounding pharmacies, revises minimum good compounding practices, provides a pharmacist must perform a final check on a product compounded by a pharmacy technician, modifies requirements for an area used for compounding in a pharmacy, provides pharmacists shall ensure certain expected features of ingredients used in a formulation, relates to the handling of sterile products by pharmacies.
SC S 183 South Carolina pharmacy practice act Pending Relates to definitions in the South Carolina pharmacy practice act, relates to compounding pharmacies, revises minimum good compounding practices, provides a pharmacist must perform a final check on a product compounded by a pharmacy technician, modifies requirements for an area used for compounding in a pharmacy, provides pharmacists shall ensure certain expected features of ingredients used in a formulation, provides a means for determining the maximum beyond-use date.
TN H 317 Pharmacy Practice Act Pending - Carryover Relates to Pharmacy, relates to Pharmacists, revises the definitions of compounding and dispense in the Pharmacy Practice Act.
TN S 582 Pharmacy Practice Act Enacted Relates to Pharmacy, revises the definition of compounding to include the preparation, mixing, assembling, packaging or labeling of a drug or device for use in a practitioner's office, medical facility, by emergency medical services or a licensed veterinarian for administration to the prescribing practitioner's patients when the product is not commercially available, provides for licensure and inspection of out of state pharmacies, exempts hospital compounding pharmacies from specified reporting.
TX S 1100 Licensing and Inspection Enacted Relates to the licensing and inspection of out-of-state pharmacies by the Texas State Board of Pharmacy, authorizes fees.
UT H 200 Utah Code Revisions Enacted Modifies parts of the Utah Code to make technical corrections, including eliminating references to repealed provisions, making minor wording changes, updating cross references, and correcting numbering, modifies parts of the Utah Code to make technical corrections, including eliminating references to repealed provisions, making minor wording changes, updating cross references, correcting numbering, and fixing errors that were created from the previous year's session.
UT S 14 Pharmacy Practice Act Enacted Amends the Pharmacy Practice Act, defines research using pharmaceuticals, exempts research using pharmaceuticals from licensure to engage in the practice of pharmacy, telepharmacy, or the practice of a pharmacy technician, exempts research using pharmaceuticals from licensure to act as a pharmacy, makes technical corrections.
VA H 2312 (2012) Compounding Pharmacies Enacted Relates to compounding pharmacies, clarifies the definition of compounding and adds a requirement for a current inspection report for registration or renewal of a registration for a nonresident pharmacy, provides that the compounding of an inordinate amount of a preparation where there is not historical pattern of prescriptions to support an expectation of receiving a valid prescription for the preparation shall constitute manufacturing of drugs.

Search courtesy of StateNet.

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.

Oversight of the U.S. Drug Supply

NEW iconU.S. Congress Passes Law Strengthening FDA Oversight of Compounding Pharmacies - On September 28, 2013 the House of Representatives passed the Drug Quality and Security Act by a voice vote.  In November, the Senate passed H.R. 3204, the "Drug Quality and Security Act," which clarifies the authority of the Food and Drug Administration to regulate specialty compounded (altered) drugs; creates a new voluntary program for FDA to regulate entities engaged in batch compounding that elect to register with the Agency; and establishes authority for FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain and minimize opportunities for contamination, adulteration, diversion, or counterfeiting.  The law was signed by the president on Nov. 27, 2013.


FDA Meeting and Actions, 2012-13
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]

Violations found in 18 States.  On April 11, 2013, the FDA announced that after a priority inspection program, federal regulators said Thursday that they had found numerous unsafe practices at 31 compounding pharmacies located in 18 states, the same type of facility responsible for the tainted drug that caused a deadly meningitis outbreak last October. The FDA Commissioner reported that, "During the course of both our proactive and reactive inspections over the past few months, we observed concerning sterility practices, inappropriate conditions for sterile processing and other practices that create risk of contamination. As of this week, we have issued to all but one pharmacy that we inspected an inspection observation report (called an FDA Form 483, or just a “483”) that lists objectionable conditions observed at the facilities. The one firm not receiving a FDA Form 483 was not producing sterile drugs."  Among the problems found were " include:  unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in “clean rooms” where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats."  The report was highlighted the next day in the N.Y. Times, 4/12/2013.
> A summary of April 2013 FDA inspections can be found on their website.

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  (some media links may require free or paid passwords)

“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,”
-- Dr. Margaret A. Hamburg, the F.D.A. commissioner, post on the agency’s blog April 11, 2013.
 

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.

Index by state:  A-C | D-H | I-L | M | N | O-R | S-U | V-W

 

Current Statute or Regulation related to Compounding Pharmacies
State Sterile Preparations/
Accreditation Examples
State Statute or Regulation | Examples     [Emphasis Added]
Alabama


 
  • Yes: Regs require
Serile Preparations, USP
  • PCAB accred. = 5

 
Pharmacy Practice Act: § 34-23-160. Preparation of compounded drug products for prescriber's office use; labeling.
(a) A pharmacy may prepare a compounded drug product for a prescriber's office use. An order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy. The product shall be administered in the prescriber's office and shall not be dispensed to the consumer. A record of the compounded drug product may be kept as a prescription record in the computer of the pharmacy. A label may be generated and a number assigned by the computer of the pharmacy for the compounded product. A record of the product's written procedure shall be on file in the pharmacy as provided in Section 34-23-156. A record of the product's sale to the prescriber shall remain on file at the pharmacy for not less than one year. The record shall contain the following information: 
(1) The name and address of the prescriber.   (2) The date of sale.  (3) A description and amount of the product sold.  (b) The label on the compounded product shall include the following information:  (1) The designated name and the strength of the finished product.  (2) The quantity dispensed.  (3) The date on which the product was compounded.  (4) The beyond use date.  (5) A lot or batch number.  (6) Any other information the pharmacist deems necessary.  (7) The name and address of the pharmacy.  (c) The label may not include the phrase “For Office use.”
Alaska
  • No
  • PCAB accred. = 0
n/a
Arizona
  • No
  • PCAB accred. = 10
Pharmacy Practice Act § 32-1981
Definitions.
In this article, unless the context otherwise requires:
7. “Wholesale distribution” means distribution of a drug to a person other than a consumer or patient. Wholesale distribution does not include:
 (a) Any transaction or transfer between any division, subsidiary, parent or affiliated or related company under common ownership and control of a corporate entity.
 (b) Selling, purchasing, distributing, transferring or trading a drug or offering to sell, purchase, distribute, transfer or trade a drug for emergency medical reasons. For the purposes of this subdivision, “emergency medical reasons” includes transferring a prescription drug by a community pharmacy or hospital pharmacy to another community pharmacy or hospital pharmacy to alleviate a temporary shortage.
 (c) Drug returns if conducted by a hospital, health care entity, retail pharmacy or charitable institution in accordance with 21 Code of Federal Regulations § 203.23.
 (d) The sale of prescription drugs by a pharmacy, not to exceed 5 percent of the pharmacy's gross sales, to practitioners for office use.
 (e) Dispensing by a retail pharmacy of prescription drugs to a patient or patient's agent pursuant to the lawful order of a practitioner.
 (f) Distributing a drug sample by a manufacturer's representative.
 (g) Selling, purchasing or trading blood or blood components intended for transfusion.
Arkansas
  • Yes: Regs require Sterile Preparations, USP
  • PCAB accred. = 3
AR State Board of Pharmacy Regulations BReg § 07-02-0002. - Good Compounding Practices.
(a) This regulation describes the requirements of minimum current good compounding practice for the preparation of drug products by pharmacies or other facilities with permits issued by the Arkansas State Board of Pharmacy.
Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of a commercially available FDA-approved drug product is generally prohibited. However, in special circumstances a pharmacist may compound an appropriate quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available based on documentation provided by the prescribing physician of a patient-specific medical need (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The recommended methodology for documenting unavailability is to print the screen of wholesalers showing back-ordered, discontinued, or out-of-stock items. This or similar documentation must be available when requested by the Board (see full text).
California
  • No
  • PCAB accred. = 21
CA Pharmacy Practice Act PracAct § 4052. - Power to perform procedures and functions; training.
(a) Notwithstanding any other provision of law, a pharmacist may:
(1) Furnish a reasonable quantity of compounded drug product to a prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer, orally or topically, drugs and biologicals pursuant to a prescriber's order.
(4) Perform procedures or functions in a licensed health care facility as authorized by Section 4052.1.
(5) Perform procedures or functions as part of the care provided by a health care facility, a licensed home health agency, a licensed clinic in which there is a physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, as authorized by Section 4052.2.
(6) Manufacture, measure, fit to the patient, or sell and repair dangerous devices or furnish instructions to the patient or the patient's representative concerning the use of those devices.
Colorado
  • Yes: Regs  require Sterile Preparations, USP
  • PCAB accred. = 3
CO Pharmacy Practice Act PracAct 12-42.5-102.
Definitions.
(7)(a) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device:
 (I) As the result of a practitioner's prescription drug order, chart order, or initiative, based on the relationship between the practitioner, patient, and pharmacist in the course of professional practice; or
 (II) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing.
 (b) “Compounding” also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
(42)(a) “Wholesale distribution” means distribution of prescription drugs to persons or entities other than a consumer or patient.
 (b) “Wholesale distribution” does not include: ....
(VI) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use;
(c)(I) A prescription drug outlet shall not compound drugs that are commercially available except as provided in subparagraph (II) of this paragraph (c).
 
CO PracAct 12-42.5-118. (II) A pharmacist may compound a commercially available drug if the compounded drug is significantly different from the commercially available drug or if use of the compounded drug is in the best medical interest of the patient, based upon the practitioner's drug order, including the removal of a dye that causes an allergic reaction. If the pharmacist compounds a drug in lieu of a commercially available product, the pharmacist shall notify the patient of that fact.
(4) Only a registered prescription drug outlet or other outlet registered pursuant to section 12-42.5-117(1)(d) may compound or dispense a prescription. Initial interpretation and final evaluation, as defined by the board, may be conducted at a location other than a registered prescription drug outlet or other outlet registered pursuant to this article in accordance with rules adopted by the board.
(6)(a) A practitioner may personally compound and dispense for any patient under the practitioner's care any drug that the practitioner is authorized to prescribe and that the practitioner deems desirable or necessary in the treatment of any condition being treated by the practitioner, and the practitioner is exempt from all provisions of this article except section 12-42.5-126.
 
(b) The board shall promulgate rules authorizing a pharmacist to compound drugs for office use by a practitioner. The rules must limit the amount of drugs a pharmacist may compound to no more than ten percent of the total number of drug dosage units dispensed and distributed on an annual basis by the outlet.
Connecticut
  • PCAB accred. = 0
CT Pharmacy Practice Act BReg 20-576-61.
General requirements for pharmacies providing radiopharmaceutical services.
(a) A license to operate a nuclear pharmacy shall only be issued to a person who is, or who employs, a nuclear pharmacist.
(c) Nuclear pharmacies shall:

(5) compound and dispense radiopharmaceuticals that meet accepted standards of radiopharmaceutical quality, including, but not limited to, standards established by the United States Nuclear Regulatory Commission; and

(d) (1) A nuclear pharmacist may transfer to authorized persons and United States Nuclear Regulatory Commission licensed medical practitioners radioactive materials not intended for drug use, in accordance with the regulations of the United States Nuclear Regulatory Commission and the Regulations of Connecticut State Agencies. A nuclear pharmacy may also furnish radiopharmaceuticals and other drug products for office use to these practitioners for individual patient use.
CT Chapter 400j Pharmacy
Sec. 20-581. Penalty for violation of Pharmacy Practice Act. Exception. Any person who violates any provision of sections 20-570 to 20-631, inclusive, and section 20-635 for the violation of which no other penalty has been provided shall be fined not more than five thousand dollars or imprisoned not more than five years or both. For purposes of this section, each instance of patient contact or consultation that is in violation of any provision of sections 20-570 to 20-631, inclusive, and section 20-635 shall be a separate offense. Failure to renew in a timely manner any license issued under said sections is not a violation for purposes of this section.
Delaware
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 0
DE Division of Professional Regulation/ BReg Chapter 2500-5
Dispensing.
5.1 The practice of dispensing shall include, but not be limited to the following acts which shall …

5.1.6 Compounding is the responsibility of the pharmacist. All compounding must be in compliance with FFDCA Section 503A and any regulations promulgated by FDA concerning compounding pertaining to this section. The pharmacist may utilize the assistance of a certified pharmacy technician under the direct supervision of a pharmacist if:
5.1.6.1 The formulation is developed by a pharmacist before proceeding with the compounding.
5.1.6.2 The compounding ingredients are checked by the pharmacist before proceeding with the compounding.
5.1.6.3 Every weight and measurement is checked by the pharmacist before proceeding with the compounding.
5.1.6.4 The finished product is checked by the pharmacist before dispensing.
5.1.7 Compounded medications for office use.
5.1.7.1 On the order of a practitioner, compounded products may be sold to the practitioner for use in his or her office to administer to individual patients, but not for resale.
District of Columbia
  • No
  • PCAB accred. = 0
DC Board of Pharmacy Regulations BReg 1320.
Distribution by Dispenser to Another Practitioner or a Reverse Distributor.
 
1320.1 A practitioner who is authorized to dispense a controlled substance may distribute (without being registered to distribute) a quantity of the substance to:
(b) Another practitioner for the purpose of general dispensing by the practitioner to his or her patients, provided that the following conditions are satisfied:
  (1) The practitioner to whom the controlled substance is to be distributed is registered appropriately to dispense that controlled substance;
 (2) The distribution is recorded by the distributing practitioner and by the receiving practitioner in accordance with 21 CFR § 1304.22(c);
 (3) If the substance is listed in Schedule I or II, an order form shall be used as required by 21 CFR § 1305; and
 (4) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section, during the twelve (12) month period in which the practitioner is registered to dispense, does not exceed five percent (5%) of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the twelve (12) month period.
Florida
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 12
FL Board of Pharmacy Regulations BReg 64B16-27.700.
Definition of Compounding.
“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner's agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this rule, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.

(1) Compounding includes:
(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis and the patient has been made aware that the compounded product will be prepared by the pharmacist. The reconstitution of commercially available products pursuant to the manufacturer's guidelines is permissible without notice to the practitioner.
 
(2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is not compounding and is not within the practice of the profession of pharmacy. Except that the supply of patient specific compounded prescriptions to another pharmacy under the provisions of Section 465.0265, F.S., and Rule 64B16-28.450, F.A.C., is authorized.
(3) Office use compounding. “Office use” means the provision and administration of a compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner for office use by the practitioner in accordance with this rule provided:
 (a) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner's office before the expiration date of the drug.
Georgia
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 3
GA Pharmacy Practice Act, PracAct 26-4-201.
Definitions.
As used in this article, the term:
(E) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use, except that nothing contained herein shall be construed to prohibit the board from requiring that other records of these transactions shall be kept in accordance with law and regulation not found in this article; …
      History: Laws 2007, Act 245, § 2..
Guam
  • Yes: Regs require
Sterile Preparations, USP
n/a
Hawaii
  • No; Sterile Preparations is a standard of practice
n/a
Idaho
  • No
  • PCAB accred. = 1
ID PracAct 54-1752.
Definitions.
As used in sections 54-1751 through 54-1759, Idaho Code:
(f) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use.
Illinois
  • No; uses state
administrative code
  • PCAB accred. = 4
IL Admin Code 1330.670
IL PracAct 225 ILCS 120/15.
Definitions.
 As used in this Act:
 “Wholesale distribution” means the distribution of prescription drugs to persons other than a consumer or patient, but does not include any of the following:
 (1) Intracompany sales of prescription drugs, meaning (i) any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under the common ownership and control of a corporate entity or (ii) any transaction or transfer between co-licensees of a co-licensed product.
 (2) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.
 (3) The distribution of prescription drug samples by manufacturers' representatives.
 (4) Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with federal regulation.
 (5) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use.
 (6) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.
Indiana
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 3
Indiana Code: PracAct 25-26-14-11.
"Wholesale distribution" defined.
 
As used in this chapter, “wholesale distribution” means to distribute legend drugs to persons other than a consumer or patient. The term does not include:
 (1) a sale or transfer between a division, a subsidiary, a parent, an affiliated, or a related company under the common ownership and control of a corporate entity;
 (2) the purchase or acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the hospital's or health care entity's own use from the group purchasing organization or from other hospitals or health care entities that are members of the organization;
 (3) the sale of a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
 (4) the sale of a drug among hospitals or other health care entities that are under common control;
 (5) the sale of a drug for emergency medical reasons, including transfers of legend drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, if the gross dollar value of the transfers does not exceed five percent (5%) of the total legend drug sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period;
 (6) the sale of a drug or the dispensing of a drug pursuant to a prescription;
 (7) the distribution of drug samples by manufacturers' representatives or distributors' representatives;
 (8) the sale of blood and blood components intended for transfusion;
 (9) the sale of a drug by a retail pharmacy to a practitioner (as defined in IC 25-26-13-2) for office use, if the gross dollar value of the transfers does not exceed five percent (5%) of the retail pharmacy's total legend drug sales during any twelve (12) consecutive months;
 (12) the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use.
Iowa
  • No
  • PCAB accred. = 4
IA Board of Pharmacy Regulations  BReg 657-16.4 (155A).
General requirements for pharmacies providing radiopharmaceutical services.
 16.4(7) Prescription and office use. Radioactive drugs shall be dispensed only upon a prescription order from a licensed medical practitioner authorized to possess, use and administer radiopharmaceuticals. A nuclear pharmacy may also furnish radiopharmaceuticals to practitioners for office use.
16.4(11) Redistribution. A nuclear pharmacy may redistribute to another nuclear pharmacy or authorized party radioactive drugs that are the subject of an approved new drug application if the pharmacy does not process the radioactive drugs in any manner or violate the product packaging.
Kansas
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 4
KS PracAct 65-1626.
Definitions.
For the purposes of this act:
 (ww) “Wholesale distribution” means the distribution of prescription drugs or devices by wholesale distributors to persons other than consumers or patients, and includes the transfer of prescription drugs by a pharmacy to another pharmacy if the total number of units of transferred drugs during a twelve-month period does not exceed 5 percent of the total number of all units dispensed by the pharmacy during the immediately preceding twelve-month period. Wholesale distribution does not include: (1) The sale, purchase or trade of a prescription drug or device, an offer to sell, purchase or trade a prescription drug or device or the dispensing of a prescription drug or device pursuant to a prescription; (2) the sale, purchase or trade of a prescription drug or device or an offer to sell, purchase or trade a prescription drug or device for emergency medical reasons;
(12) the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use.
Kentucky
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 4
KY Board of Pharmacy Regulations BReg 902 KAR 55:060.  (only applies to) Requirements for distribution of small amounts of controlled substances without manufacturer's or wholesaler's licenses.
Section 1. Distribution of Controlled Substances by Pharmacy to Practitioner or other Pharmacy.
(1) A pharmacy may distribute a quantity of a controlled substance to a practitioner or another pharmacy, without being licensed as a manufacturer or wholesaler in Kentucky if it:
(a) Is licensed in Kentucky;
(4) The total number of dosage units of all controlled substances distributed by a pharmacy pursuant to this administrative regulation during a 12 month period shall not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the pharmacy during the 12 month period. If the 5 percent limitation is expected to be exceeded, the pharmacy shall obtain a license to distribute controlled substances in accordance with KRS 218A.160 and 218A.170; and
 (5) A prescription shall not be issued by a practitioner to obtain any controlled substance for the purpose of general dispensing, administering or office use.
History: effective April 14, 1982; effective June 04, 1985; effective November 25, 1991; effective January 10, 1994.
Louisiana
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 4
LA Board of Pharmacy Regulations BReg 105.
Wholesale Drug Distribution Exemptions.
A. Wholesale drug distribution does not include:
 8. the sale of legend drugs by retail pharmacies to licensed practitioners for office use where the annual dollar volume of legend drugs sold to licensed practitioners does not exceed 5 percent of the dollar volume of that retail pharmacy's annual legend drug sales.
Maine - ME Board of Pharmacy Regulations 36. - Wholesale distribution.
“Wholesale distribution” is the distribution of prescription drugs by wholesale distributors to persons other than consumers or patients, but does not include:
....
(6) The sale of a drug by a retail drug outlet to licensed practitioners for office use when the total annual dollar volume of prescription drugs sold to licensed practitioners does not exceed five (5) percent of that drug outlet's total annual prescription drug sales; ....
Maryland
  • Yes: Regs require
Sterile Preparations, USP
MD  PracAct 12-6C-01.Wholesale Distributor Permitting and Prescription Drug Integrity- Definitions.
In general
(2) “Wholesale distribution” does not include:
(vi) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed health care practitioners for office use;
 (vii) The sale, purchase, or trade of a prescription drug, an offer to sell, purchase, or trade a prescription drug, or the dispensing of a prescription drug in accordance with a prescription.
Massachusetts
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 4
Massachusetts General Law Chapter 94C, section 21 and Department of Public Health regulations (105 CMR 721.000) require that pharmacies and pharmacists dispense medications pursuant to a valid prescription from an authorized practitioner for a specific patient. This prescription must be valid as defined under Massachusetts statutes and regulations, not under the rules governing prescriptions in the recipient state.
The Board of Registration in Pharmacy Regulations (247 CMR) require that all actions be performed in accordance with United States Pharmacopeia (USP) Standards. 247 CMR 9.01(3).
Notice: DPH Advisory for Compounding Pharmacies and Pharmacists, October 2012.
Michigan
  • No
  • PCAB accred. = 6
MI Board of Pharmacy Regulations  R 338.493a.
Applicability; distributions by pharmacies; license requirements.
 (3) If the total number of dosage units of all prescription drugs that are prepared or compounded by a pharmacy for resale, compounding, or dispensing by another person, as defined in section 1106 of the code, during any consecutive 12-month period is more than 5 percent of the total number of dosage units of prescription drugs prepared by the pharmacy during the 12-month period, then the pharmacy is a manufacturer as defined in section 17706(1) of the code.
Minnesota
  • Yes: Regs require
Sterile Preparations, USP
-
Mississippi
  • No
  • PCAB accred. = 2
 
Missouri
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 2
MO Board of Pharmacy Regulations BReg 20 CSR 2220-5.020.
Drug Distributor Licensing Requirements.
Purpose: This rule defines terms and requirements for the lawful licensure of drug distributors.
(1) A “wholesale drug distributor” is defined in section 338.330(3), RSMo. No wholesale drug distributor with physical facilities located in the state of Missouri shall knowingly purchase or receive legend drugs and/or drug related devices from a wholesale drug distributor or pharmacy not licensed or registered by the board. Knowledge of the licensure status of a drug distributor or pharmacy includes, but is not limited to, actual or constructive knowledge. Knowledge of the license status of a drug distributor or pharmacy shall also include, but not be limited to, notification from the board by mail or electronic transmission.
 (A) A wholesale drug distributor is further defined as anyone engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.
  (B) A wholesale drug distributor does not include:
 1. The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug for emergency medical reasons. For purposes of this section, emergency medical reasons includes transfers of prescription drugs by a licensed pharmacy to anyone other than a licensed pharmacy that constitutes five percent or less of total gross sales of the pharmacy; and ....
Montana
  • No
n/a
Nebraska
  • No
  • PCAB accred. = 1
NE PracAct 71-7444.
Wholesale drug distribution, defined.
 
(1) Wholesale drug distribution means the distribution of prescription drugs to a person other than a consumer or patient.
(2) Wholesale drug distribution does not include: ...
(e) The sale, purchase, or trade of, an offer to sell, purchase, or trade, or the dispensing of a prescription drug pursuant to a prescription;
Nevada
  • No; uses state admin. code
  • PCAB accred. = 3
n/a
New Hampshire
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 1
n/a
New Jersey
  • Yes: Regs require
Sterile Preparations, state
  • PCAB accred. = 6
n/a
New Mexico
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 1
n/a
(PCAB list updated 6/2013)
New York
  • No
  • PCAB accred. = 10
n/a
North Carolina
  • No
  • PCAB accred. = 6
n/a
North Dakota
  • No
  • PCAB accred. = 0
n/a
Ohio
  • No
  • PCAB accred. = 2
n/a
Oklahoma
  • Yes: Regs require Sterile Preparations, USP
  • PCAB accred. = 1
OK Board of Pharmacy Regulations  BReg 535:15-10-12.
Compounding for a prescriber's office use.
 (a) Pharmacies engaging in compounding may prepare compounded drug preparations for a licensed prescriber's office use.
 (b) An order by the licensed prescriber indicating the formula and quantity ordered will be filed in the pharmacy.
(c) The preparation is to be administered in the office and not dispensed to the patient. The preparation label should state “for office use only-not for resale.”
(d) An invoice shall be kept on file by the pharmacy. This invoice shall include, but not be limited to, the name and address of purchaser, quantity sold, drug description, price, and date of transaction. These invoices must be readily available for inspection. A drug supplier permit is required per OAC 535:15-7.
(e) A record of the compounded drug may be kept as a prescription record in the pharmacy computer and a label may be generated and a number assigned by the pharmacy computer for the compounded drug
(f) Under Oklahoma Bureau of Narcotics rules [475:30-1-3 (b) et seq.], a prescription for controlled dangerous substances cannot be filled “for office or medical bag use.”
(g) Compounded preparations may not be given or sold for resale by practitioners or other persons.
  -- 17 Ok Reg 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff 7-1-09.
OK Board of Pharmacy Regulations BReg Part 3. Good Compounding Practices for Sterile Products/
OK BReg 535:15-10-64. Compounding for institution and/or practitioner administration.
 (a) The purpose of this section is to provide standards for the compounding of preparations pursuant to a prescription for a patient from a practitioner in a different health care facility or institutional pharmacy. Since compounding is already based on the practitioner/patient/pharmacist triad, this should be satisfied when a practitioner writes an order to administer the drug in the medical record.
 (b) A compounded product shall NOT be sold to a third party for resale.
 (c) A retail pharmacy that provides compounded preparations to an institutional pharmacy shall obtain a Compounding Drug Supplier Permit from the Board prior to such activity.
 (d) A retail pharmacy that provides compounded preparations to practitioners for office use or to an institutional pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall:
(1) Address acceptable standards of practice for each party entering into agreement and include a statement that the compounded preparation may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity;
 (2) Include liability language, references to performance improvement and quality controls;
 (3) require the practitioner or receiving pharmacy to include on patient's record, medication order, or medication administration record the batch number and BUD of the compounded preparation administered to a patient;
 (4) Describe the scope of services to be performed by the filling pharmacy and practitioner or receiving pharmacy, including a statement of the process for:
 (A) A patient to report an adverse reaction or submit a complaint; and
 (B) The pharmacy to recall compounded preparations.
 (e) Records of orders and distributions of compounded preparations to a practitioner for office use or receiving pharmacy shall be kept by pharmacy for at least 5 years and be available for inspection. These records shall be maintained separately from the records of products dispensed pursuant to a prescription.
Oregon
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 3
n/a
Pennsylvania
  • pending
  • PCAB accred. = 1
n/a
Puerto Rico
  • Yes: Regs require
use of USP standards
n/a
Rhode Island
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 1
n/a
South Carolina
  • No
  • PCAB accred. = 2
n/a
South Dakota
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 2
n/a
Tennessee
  • No
  • PCAB accred. = 3
Board of Pharmacy Regulations Chapter 1140-6. - Nuclear Pharmacy Practice Sites
TN BReg 1140-6-.02. General requirements.
(2) The compounding and dispensing area for radioactive drugs shall be separate from the compounding and dispensing area for non-radioactive drugs, and shall be secured from unauthorized personnel.
(5) A pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with T.C.A. 68-202-206. A nuclear pharmacy practice site may also furnish radiopharmaceuticals for office use to authorized practitioners for individual patient use.
Texas
  • PCAB accred. = 16
S.B. 492 of 2005 Relating to inspection of and drug compounding by a pharmacy and to distribution of compounded and prepackaged drugs to pharmacies under common ownership. (Summary)
In recent years, a growing number of medications have been unavailable from the manufacturer for various reasons, sometimes these shortages can last months or longer. The result is that some critical products are unavailable for essential patient care demands in hospitals, clinics, and surgical centers. Such medications required compounding and the challenge is to ensure that the process occurs in the most controlled and safe pharmacy environment. Compounding pharmacists do not compound if the drug is commercially available and pharmacies do not compound, dispense, sell, or distribute without a physician's order or prescription.
S.B. 492 amends the Occupations Code to allow for dispensing, sale, or distribution of compounded drugs to state-licensed physicians for in-house administration and the distribution of compounded and prepackaged products to and from pharmacies under common ownership.

TX PracAct Subchapter D. Compounded and Prepacked Drugs/

TX PracAct Sec. 562.151. Definitions.  (Added by Acts 2005, chapter 28, § 4, effective Sept. 1, 2005)
(1) “Office use” means the provision and administration of a compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy in accordance with Chapter 563.
 (2) “Prepackaging” means the act of repackaging and relabeling quantities of drug products from a manufacturer's original container into unit dose packaging or a multiple dose container for distribution within a facility licensed as a Class C pharmacy or to other pharmacies under common ownership for distribution within those facilities. The term as defined does not prohibit the prepackaging of drug products for use within other pharmacy classes.
 (3) “Reasonable quantity” with reference to drug compounding means an amount of a drug that:
 (A) does not exceed the amount a practitioner anticipates may be used in the practitioner's office before the expiration date of the drug;
 (B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and
 (C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.
   ---------------
TX PracAct Sec. 562.152. - Compounding for Office use.
 A pharmacy may dispense and deliver a reasonable quantity of a compounded drug to a practitioner for office use by the practitioner in accordance with this chapter.
  ----------
TX PracAct Sec. 562.153. - Requirements for Office use Compounding.
To dispense and deliver a compounded drug under Section 562.152, a pharmacy must:
 (1) verify the source of the raw materials to be used in a compounded drug;
 (2) comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, and the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191);
 (3) comply with all applicable competency and accrediting standards as determined by the board; and
 (4) comply with board rules, including rules regarding the reporting of adverse events by practitioners and recall procedures for compounded products.
   -----------------------
TX Board of Pharmacy Regulations Sec. 291.131. - Pharmacies Compounding Non-Sterile Preparations.
(a) Purpose. Pharmacies compounding non-sterile preparations, prepackaging pharmaceutical products and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the:
(1) compounding of non-sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies;   ....
  -------------------------
TX Board of Pharmacy Regulations Sec. 291.133. - Pharmacies Compounding Sterile Preparations. 
[NCSL NOTE: This 30-page regulation includes comprehensive examples of regulatory language- copy available upon request]
(a) Purpose. Pharmacies compounding sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the:
 
(1) compounding of sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies;
Utah
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 1
n/a
Vermont
  • No
  • PCAB accred. = 0
n/a
Virginia
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 2
n/a
Washington
  • No
  • PCAB accred. = 4
n/a
West Virginia
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 2
n/a
 
Wisconsin
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 2
n/a
Wyoming
  • Yes: Regs require
Sterile Preparations, USP
  • PCAB accred. = 0
WY Board of Pharmacy Regulations Chapter 8 Section 4. Wholesale pharmacy regulations restrict activities to include:
"(vi) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use;"

 

Federal Standards for Pharmacies and Pharmactists

** For pharmacies and pharmacists who engage in compounding, many states require that all "actions be performed in accordance with United States Pharmacopeia (USP) Standards."  USP<795> addresses the practice for Non-Sterile Compounding and USP Standard <797> addresses the practice for Sterile Compounding Preparations.

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. Learn more.

USP-NF Photo of book


A report released October 2012 by Congressman Edward Markey (Mass.), whose district includes New England Compounding, "Compounding Pharmacies, Compounding Risk, "reveals before current outbreak at least 23 deaths, 86 serious illnesses and injuries associated with compounding pharmacy practices.  The report cites F.D.A. records,  stating "there had been 'adverse medical incidents' related to compounding in at least 34 states. The statistics did not include the current meningitis outbreak.  The report also included a review of state pharmacy boards and found that they do not generally undertake enforcement actions that relate to the safety or scope of compounding.  The report describes their focus " to be more on traditional pharmacy activities, including licensing and controlled substances."  >  Massachusetts lawmaker seeks greater pharmacy regulation - Fox News Boston, 11/2/2012.
 

2011 - 2012 Enacted Legislation Related to Compounding Pharmacies
State and Bill Number Summary
AL H 393  Practice and Operation of Pharmacies; enacted 04/19/2012 Relates to the practice of pharmacy and the operation of pharmacies; defines pharmacy services; authorizes the Alabama State Board of Pharmacy to provide by rule for the issuance, renewal, and fees relating to a pharmacy services permit; provides that the creation of a pharmacy services permit does not expand or limit the existing practice of pharmacy or medicine.
AL S 383 Audits of Pharmacy Records; enacted 05/09/2012 Relates to audits of pharmacy records; establishes minimum and uniform standards and criteria for the audit of pharmacy records by or on behalf of certain entities; prescribes the procedures for conducting an audit; provides for an appeal process; provides that an entity conducting an audit may not use the accounting practice of extrapolation in calculating recoupments or penalties for audits.
AL H 566 Prescription Drugs; enacted 05/23/2012; act 2012-553 Relates to prescription drugs; allows a named federally qualified health care center and public health facility to compound and dispense non-controlled substances at one location and deliver the medications to clinics for patient pick-up.
CO H 1311 State Pharmacy Board; enacted 06/08/2012; Ch. 281 Relates to the continuation of the State Board of Pharmacy, the rehabilitation evaluation committee and transfers its duties to the state board, license fee increase to cover the costs of the Pharmacy Peer Health Assistance Program, hospital satellite pharmacies, veterinary prescription drug wholesalers, board letters of admonition, pharmacist managers, interns, and prescription requirements.
IN H 1280 Regulation of Interstate Commerce; enacted 03/19/2012; Public Law 152 Relates to regulatory matters; provides that intrastate commerce is not subject to the authority of the United States Congress; provides a review of agency rules; imposes a duty on a state agency to give a person an opportunity to correct a violation discovered in an inspection; requires hearing officers and administrative law judges to be licensed attorneys; provides for carrier regulation, in-state products, public hearings, franchise fees and mail order pharmacy permits.  (expands rights of Rx)
KS H 2182 House Aging and Long-term Care Committee; enacted 05/25/2011; Ch. 114 Amends health care provisions; includes pharmacy audit procedures, pharmacy benefit managers, resident's right to purchase or refuse to purchase health insurance; provides for acceptance of unused medications, health provider licensure and regulation, physical therapists, addiction counseling, electronic health records and confidentiality, health care representatives, school sports head injury prevention, EMS, dentists, nurses and smoking laws.
KS S 397 Mental Retardation Definition; enacted 04/06/2012; Ch. 91 Relates to terminology change from mental retardation and similar terms to intellectual disability and similar terms.
KS S 134 Advanced Practice Registered Nurse; enacted 05/04/2012; Ch. 107 Creates the licensure role of advanced practice registered nurse; relates to renewal of licenses; provides grounds for disciplinary action for violations; relates to felony convictions; relates to evidence of completion of continuing education; amends provisions regarding prescribing of drugs.
KS S 211 Dispensing Prescriptions; enacted 05/17/2012; Ch. 121 Concerns pharmacists; relates to dispensing prescriptions; provides that a pharmacist may provide up to three-month supply of a prescription drug that is not a controlled substance or psychotherapeutic drug when a practitioner has written a drug order to be filled with a smaller supply but included sufficient numbers of refills for a three-month supply.
KS H 2792 Amendment Reconciling; enacted 05/31/2012; Ch. 166 Reconciles amendments to certain statutes and makes certain technical changes related thereto, including statutes relating to ad valorem taxes, payroll withholding taxes, unemployment contribution taxes, insurance agents or insurance solicitor, health insurers and health maintenance organizations, and tax information of firms contracting with the Secretary of Revenue.
KY S 3 Drugs; enacted 04/11/2012; Ch. 122 Relates to drugs; includes drugs containing non-liquid ephedrine, pseudoephedrine, or phenylpropanolamine within the definition of a legend drug; limits the amount of ephedrine-based, pseudoephedrine-based, or phenylpropanolamine-based legend drugs available without a prescription to 15 grams per year and 3.6 grams per month; requires the use of the electronic sales logging system, to require the system to block sales to certain purchasers, and to require annual statistical reporting.
MI S 1082 Synthetic Cannabinoids; enacted 06/19/2012; Public Act 183 Classifies synthetic cannabinoids as schedule 1 controlled substances; prohibits selling and offer to sell certain products represented to contain controlled substances or having the effects of controlled substances.
MN H 1236 Pharmacy Record Audits; enacted 04/23/2012; Ch. 215 Establishes a program for the audit of pharmacy records carried out by a pharmacy benefits manager or a representing entity; prohibits a pharmacy benefits manager from requiring that certain information be written on a prescription; provides that recoupment may be assessed for certain information not written on a prescription, including information relating to a drug manufacturer's product safety program; requires copies of claims included in an audit to be provided to a plan sponsor.
MN S 1675 Human Services Revisions; enacted 04/23/2012; Ch. 216 *companion H 1967 Relates to human services; modifies provisions related to children and family services; reforms adoptions under guardianship of the commissioner; modifies statutory provisions related to child support; relates to employer payroll taxes and unemployment taxes, employee health and disability insurance, liability insurance, and workers' compensation insurance.
MN H 2508 Public Safety; enacted 04/27/2012; Ch. 240 *companion S 2319 Relates to public safety; aligns state-controlled substance schedules with federal controlled substance schedules; modifies authority of the Board of Pharmacy to regulate controlled substances; provides for penalties.
MN H 2532 Health; enacted 04/28/2012; Ch. 246 *companion S 2128 Relates to health; allows prescriptions for controlled substances to be transmitted electronically or by facsimile if the prescription meets State law and federal regulations.
MN S 2493 Natural Resources; enacted 05/01/2012; Ch. 264 Relates to natural resources; appropriates money from the outdoor heritage fund; modifies requirements for outdoor heritage fund appropriations; appropriates money for clean water; appropriates money for an Aquatic Invasive Species Cooperative Research Center; modifies prior appropriations; modifies specified parks and trails grant program provisions.
NE L 179 Pharmacy Provisions; enacted 03/10/2011; signed by Governor Changes pharmacy provisions; changes prescribing provisions under the Uniform Controlled Substance Act; defines the term samples to mean a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug; provides that to be eligible to take the pharmacist licensure examination, every applicant must present proof of graduation from an accredited pharmacy program.
NJ A 3104 Department of Health; enacted 06/29/2012; Ch. 17 *companion S 2072 Reorganizes and renames Department of Health and Senior Services as Department of Health; establishes Division of Aging Services in Department of Human Services; transfers certain services and programs for senior citizens from the Department of Health and Senior Services to the new Division of Aging Services; revises various parts of the statutory law to include the provisions governing the Medical Malpractice Insurance Premium Assistance Fund.
OH H 86 Criminal Code; enacted 06/29/2011; Session Law 29 Relates to Medicaid and workers' compensation fraud, trafficking in controlled substances, child-victim offenders, violent offender escape, parole hearings, prisoner credits, post-release GPS monitoring, pretrail and postconviction confinement, inmate reentry plan, a offender risk assessment tool, community control sanctions, juvenile probation grants, delinquent youth task force, truancy, inmate assault, speeding violations, older inmate parole, shoplifting, identity fraud, and crime victims.
OH H 487 Appropriation, Taxes and State Programs; enacted 06/11/2012; Ch. 127 Makes operating and other appropriations; provides authorization and conditions for the operation of state programs; relates to the levying of a tax by school districts; relates to the taxation of independent living facilities; relates to regional transit authority taxation; relates to special district taxation; relates to the liability insurance of motor carriers; relates to gross premium taxation; relates to liability insurance for fireworks manufacturers; relates to workers' compensation insurance.
OK S 919 Narcotics and Dangerous Drugs; enacted 05/13/2011; Ch. 239 Relates to the Uniform Controlled Dangerous Substances Act; designates certain substances as Schedule I through Schedule V substances; authorizes an electronic prescription method; clarifies the weight amounts for certain substances; modifies the agency responsible for the destruction of seized or surrendered property; requires the registration with the State Dangerous Drugs Control Registry of persons convicted in other jurisdictions; modifies the registration time limitation.
OK S 878 Workers’ Compensation; enacted 05/24/2011; Ch. 318 Provides for a mass revision of the Workers' Compensation Code.
OK H 2942 Controlled Dangerous Substances; enacted 04/17/2012; Ch. 80 Relates to public health and safety; relates to the Uniform Controlled Dangerous Substances Act; adds certain substances to certain schedules; relates to prescriptions; authorizing use of electronic prescribing methods; relates to the Anti-Drug Diversion Act; deletes exception to transmission requirement for nonresident drug outlets; amends provision relating to drug cleanup fines; makes the imposition of cleanup fines discretionary.
OK H 2941 Electronic Pharmacy Records; enacted 05/08/2012; Ch. 206 Requires electronic pharmacy records of nonprescription pseudoephedrine or ephedrine sales; directs pharmacies to electronically submit information prior to completing certain sales; provides an exception; makes pharmacies exempt from civil liability under certain circumstances; provides for the confidentiality of information collected; provides exemptions; provides for purchase restrictions; provides for stop-sale alerts and the methamphetamine offender registry; allows a service charge for such products.
RI H 5211 Business and Professions; enacted 06/22/2011; Ch. 109 Allows the administration of immunizations by a pharmacy to adults and children nine years of age and older; require a pharmacist who is authorized to administer immunizations to electronically report to the Department of Health all immunizations administered within fourteen days of administration in the format and for the populations required by the department; takes effect upon passage.
RI S 480 Immunizations by Pharmacists; enacted 06/21/2011; Ch. 91 Allows the administration of influenza immunizations by a pharmacy to adults and children 9-18 years of age pursuant to a valid prescription and necessary training requirements; requires parental consent for immunizations for children under 18; requires a pharmacist who is authorized to administer immunizations to electronically report to the department of health all immunizations administered within 7 days of administration in the format and for the populations required by the department.
UT H 254 Controlled Substances Act; enacted 03/22/2012; Ch. 297 Modifies the Controlled Substances Act; amends the definition of a controlled substance to allow proof that the substance is chemically substantially similar to a controlled substance, without requiring proof of the effect of the substance by the expert testimony of a pharmacologist; adds benzylpiperazine to Schedule I of the controlled substances list; adds AM-2201, RCS-4, JWH-210, and JWH-203 to the list of listed controlled substances.
UT H 434 Pharmacy Practice Act; enacted 03/22/2012; Ch. 320 Amends the Pharmacy Practice Act; amends the definition of a pharmacy preceptor; amends provisions relating to a prescribing practitioner providing sample drugs to a patient.
UT H 76 Health Benefits and Insurance; enacted 03/22/2012; Ch. 265 Requires health benefit plans, the Public Employees' Benefits and Insurance Program, and pharmacy benefit managers to implement certain pharmacy audit procedures when auditing pharmacy claims; requires a health insurer and a pharmacy benefits manager for a health insurer to comply with pharmacy audit rights established in the Pharmacy Practice Act; requires the Public Employees' Benefit and Insurance Program to comply with pharmacy audit rights established in the Pharmacy Practice Act.
VA H 733 Pharmacists; enacted 03/08/2012; Ch. 173 Relates to pharmacists; relates to compounding authority; increases pharmacists' authority to compound to allow the compounding of a commercially manufactured drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage, or a commercially manufactured drug when the prescriber has indicated in the prescription for an individual patient that there is an emergent need for a drug that is not readily available within the medically necessary time.
VA S 294 Methamphetamine Precursors; enacted 03/07/2012; Ch. 160 *companion H 1161 Relates to methamphetamine precursors; relates to pharmacies, sale and tracking; relates to penalties; requires the Department of State Police to enter into a memorandum of understanding to establish the Commonwealth's participation in a real-time electronic recordkeeping and monitoring system for the nonprescription sale of ephedrine or related compounds; provides a penalty for failure to report sales.
VA H 346 Nurse Practitioners Practice; enacted 03/10/2012; Ch. 213 Amends provisions governing the practice of nurse practitioners; provides that nurse practitioners shall only practice as part of a patient care team, which shall include at least one licensed patient care team physician; relates to persons licensed to practice osteopathy when taking blood or giving injections; relates to fitting artificial limbs; requires professional liability insurance; relates to prescribing controlled substances.
VA H 1301 Budget Bill; enacted 06/11/2012; Ch. 3 *line item vetoed by Governor Relates to budget Bill; provides that appropriations of the Budget providing a portion of revenues for the two years ending respectively on the thirtieth day of June, 2013, and the thirtieth day of June, 2014; relates to a study of restructuring the local Business, Professional, and Occupational License Tax; authorizes an annual food-related inspection fee; relates to third party coverage under a medical support order; requires the modernization of the unemployment insurance benefits and tax system.
WA H 1486 Pharmacies and Prescriptions; enacted 03/07/2012; Ch. 8 *companion S 5390 Authorizes Washington pharmacies to fill prescriptions written by advanced registered nurse practitioners in other states.
WA H 2056 Assisted Living Facilities; enacted 03/07/2012; Ch. 10 Changes the term boarding home to assisted living facility throughout the boarding home licensing statute and elsewhere in the state Revised Code; provides that the Department of Social and Health Services is authorized to apply rules regarding boarding homes to assisted living facilities.
WV S 437 Substance Abuse and Controlled Substances; enacted 03/09/2012; Ch. 83 *same as H 4336 Relates generally to substance abuse; relates to opioid treatment programs and facilities, education and training requirements for treatment facility staff, licensing and oversight of chronic pain management clinics, end-of-life care education, health professional drug diversion training, the compounding and dispensing of prescriptions, a controlled substances monitoring program, methamphetamine laboratories and restrictions on the sale of ephedrine, pseudoephedrine and precursors, and related matters.
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