Authority to Prescribe
1. Can certified nurse practitioners and PAs write prescriptions for C-II controlled substances?
Certified nurse practitioners and PAs can write prescriptions for C-II controlled substances if the following requirements have been met:
- Must be registered with the Board of Medical Examiners with a DEA # and have the practice registration amended to include C-IIs.
- Must have a current collaborative practice agreement.
- Must have an active Qualified Alabama Control Substance Certificate (QACSC) in order to write C-III through C-V prescriptions.
- Must have an active Limited Purpose Schedule II Permit (LPSP)–an extension of the QACSC to include practice specific C-II prescriptions. The permit number will be the same as the QACSC certificate number.
The medication being prescribed must fall within the practitioner’s scope of practice and be listed in the formulary set forth by the collaborating physician. In order to verify which C-IIs are allowed to be prescribed by a practitioner, visit the Alabama Board of Medical Examiner’s website: www.albme.org Code of Ala. §20-2-260
2. Can certified nurse practitioners and PAs write prescriptions for C-III through C-V controlled substances?
According to the Alabama Board of Medical Examiners & Medical Licensure Commission of Alabama,
“The Alabama Legislature has passed Act 2013-223 which confers to Certified Registered Nurse Practitioners and Certified Nurse Midwives authority to prescribe controlled substances in Schedules, III, IV, and V. The Board (Medical Board) will act as the certifying board and issue Qualified Alabama Controlled Substances (QACSC) certificates in much the same way that Physician Assistants are issued QACSCs, that is, a CRNP/CNM in a collaborative agreement with a physician may apply for a QACSC to prescribe controlled substances in Schedules III, IV and V without a collaborating physician’s review or signature, provided such is agreed to in the collaborative practice agreement.”
To qualify for a controlled substances certificate, a CRNP or CNM must:
- Be in a collaborative practice with a physician who holds a valid, unrestricted Alabama Controlled Substances Certificate (ACSC).
- Submit documentation of attendance at an eight credit, Board approved course entitled, “Prescribing Controlled Drugs,” plus attendance at four credits of advanced pharmacology and controlled substance prescribing trends.
- Provide documentation of a minimum of 12 months of active clinical practice pursuant to an approved collaborative agreement. Once the required information is submitted to the Medical Board, the applicant must submit a form to DEA. DEA will confirm with the Alabama Medical Board that the person is approved for authority to prescribe controlled substances and will provide the nurse with a DEA number. Look for the nurse’s DEA number on prescriptions you receive from CRNPs.
Ala. Admin. Code 540-X-18-.03
1. CAN A PHARMACIST SUBSTITUTE AN INTERCHANGEABLE BIOSIMILAR?
Yes, a pharmacist is allowed to dispense an interchangeable biosimilar. The pharmacist must inform the patient prior to dispensing and communicate with the prescriber within 24 hours. The pharmacist must provide the prescribing practitioner with the name and manufacturer of any interchangeable biosimilar product dispensed.
Code of AL §34-23-8.1
Destruction of Unwanted Medications
1. What are my options for disposing of unwanted medications?
Many community-based drug “take-back” programs offer the best option. A small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed. Many of these medicines have specific disposal instructions on their labeling or patient information leaflet. CLICK HERE for a list of medications recommended by the FDA for disposal by flushing and more information concerning medication destruction.
A pharmacy is allowed to take back medications for the purpose of disposal if registered with DEA as a registered collector. DEA authorization to be a collector must be submitted to the Board within 10 days of receipt from DEA.
21 CFR §1317.40
Ala. Admin. Code 680-X-2-.42
2. Are there guidelines in place for proper disposal of unwanted medications?
The following guidelines were developed to encourage the proper disposal of medicines and help reduce harm from accidental exposure or intentional misuse after they are no longer needed:
- Follow any specific disposal instructions on the prescription drug labeling or patient information that accompanies the medicine. Do not flush medicines down the sink or toilet unless FDA safe disposal of medicine states you can.
CLICK HERE for more information on safe drug disposal.
- Take advantage of programs that allow the public to take unused drugs to a central location for proper disposal. Call your local law enforcement agencies about take back or contact your city or county government’s household trash and recycling service to learn about medicine disposal options and guidelines for their area.
- Contact your local pharmacy to find out if it is a registered DEA collection site.
3. What if there are no medicine take-back programs in my area?
If no medicine take-back programs or DEA-authorized collectors are available in your area, you can also follow these simple steps to dispose of most medicines in the household trash:
- Mix medicines (do not crush tablets or capsules) with an unpalatable substance such as dirt, kitty litter, or used coffee grounds,
- Place the mixture in a container such as a sealed plastic bag,
- Throw the container in your household trash,
- Scratch out all personal information on the prescription label of your empty pill bottle or empty medicine packaging to make it unreadable, and then dispose of the container.
1. Can a pharmacist give an emergency refill on a weekend if a patient needs it when there are no refills left on the prescription?
In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication, providing that:
- The prescription is not a medicinal agent listed in Schedule II appearing in Title 20, Chapter 2.
- The prescription is not a medicinal agent listed in Schedule III appearing in Title 20, Chapter 2.
- The medication is essential to the maintenance of life or the continuation of therapy in a chronic condition. Only those drugs designed by a joint rule adopted by the board of pharmacy and the board of medical examiners shall be refilled, according to the procedure established in this section
- The dispensing pharmacist created a written order containing all the prescription information required by this chapter and Title 20, Chapter 2.
- The dispensing pharmacist notifies the prescriber of the emergency dispensing within 72 hours after such dispensing.
1. Do prescription orders or prescription documents have an expiration date?
Non-controlled legend drugs: There is no expiration date for a prescription for any non-controlled, legend drug.
Schedule II controlled substances: There is no expiration date for prescriptions written for schedule II controlled substances.
Schedule III-IV controlled substances: Prescriptions for schedule III-IV controlled substances expire 6 months after the written date on the prescription or after 5 refills, whichever comes first.
21 CFR §1306.22
Schedule V controlled substances: There is no expiration date for prescriptions written for schedule V controlled substances.
21 CFR §1306.22
EXCEPTION: The partial filling of a Schedule V does subject the prescription to a six-month limitation.
21 CFR §1306.23
2. If a patient does not pick up his or her prescription and the medication is returned to stock, what is the resulting expiration date?
If the stock bottle for that medication has been thrown away, the resulting expiration date is either the expiration date on the label or 12 months, whichever date is less. If the stock bottle has not been thrown away, it is acceptable to use the expiration date printed on the stock bottle.
1. Can prescription orders be transmitted by fax in Alabama?
A written prescription for a Schedule II, which has been signed by the practitioner, may be faxed to a pharmacy provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance.
Schedule II prescriptions may be faxed for patients under hospice care or in a long-term care facility; and the faxed prescription may serve as the original for recordkeeping purposes.
1. Must a prescription label state the drug’s generic name?
Unless otherwise indicated by the practitioner, the prescription label on the dispensing container shall indicate the actual drug product dispensed, either the brand name, or if none, the generic name, and the name of the manufacturer or a reasonable abbreviation of the name of the manufacturer.
Code of Ala. §34-23-8
2. What should be on the label of a prescription?
The following is required to be on the label of a prescription:
- Name and address of the dispensing pharmacy
- Serial number of the prescription (Prescription Number)
- Date of the prescription
- Name of the prescriber
- Name of the patient
- Name and strength of the drug
- Directions for use
- Appropriate cautionary statements, such as “do not take with food” or “shake well”
- How soon must I notify the ALBOP with change of employment?
2. How often must a pharmacist renew their license?
Must renew biennially on even numbered years (license expires December 31st of that year).
Code of Ala. §34-23-52
3. How many continuing education (CE) hours must a pharmacist obtain each renewal?
A pharmacist must obtain 30 ACPE approved CE hours, requiring 6 of those to be “live”.
Ala. Admin. Code 680-X-2-.36
MEDICATION SAFETY: SHARPS AND SHARPS CONTAINERS
1.What safety precautions should I be aware of when using sharps?
Sharps is a medical term for devices with sharp points or edges that can puncture or cut skin. They may be used at home, at work, and while traveling to manage the medical conditions of people or their pets, including allergies, arthritis, cancer, diabetes, hepatitis, HIV/AIDS, infertility, migraines, multiple sclerosis, osteoporosis, blood clotting disorders, and psoriasis. Sharps Include:
- Needles: hollow needles used to inject drugs under the skin.
- Syringes: devices used to inject medication into or withdraw fluid from the body.
- Lancets/ “fingerstick” devices: instruments with a short, two-edged blade used to get drops of blood for testing.
- Auto Injectors: syringes pre-filled with fluid medication designed to be selfinjected into the body (ex: epinephrine and insulin pens).
- Infusion sets: tubing systems with a needle used to deliver drugs to the body.
Used sharps should be immediately placed in a sharps disposal container. FDA-cleared sharps containers are generally available through pharmacies, medical supply companies, and health care providers and online. These containers are made of puncture-resistant plastic with leakresistant sides and bottom. They also have a tight fitting, puncture-resistant lid.
If an FDA-cleared container is not available a heavy-duty plastic household container, such as a laundry detergent container can be used as an alternative.
FDA guidelines on the safe and proper use of sharps can be viewed HERE.
2.What precautions should I take when disposing of sharps?
Never place loose needles and other sharps (those that are not placed in a Sharps disposal container) in the household or public trash cans or recycling bins, and never flush them down the toilet. This puts trash and sewage workers, janitors, housekeepers, household members, and children at risk of being harmed.
Pet owners who use needles to give medicine to their pets should follow the same sharps disposal guidelines used for humans.
FDA guidelines for safe and proper disposal of sharps can be viewed HERE.
3.What should I do if I am accidentally stuck by used needle or other sharp?
If you are accidentally stuck by another person’s used needle or other sharp:
- Wash the exposed area right away with water and soap or use a skin disinfectant (antiseptic) such as rubbing alcohol or hand sanitizer.
- Seek immediate medical attention by calling your physician or local hospital
Follow these same instructions if you get blood or other bodily fluids in your eyes, nose, mouth, or on your skin.
FDA recommendations can be viewed HERE.
MEDICATIONS FOR THE TREATMENT OF ADDICTION
1. Can Suboxone be used for pain management?
Yes. If the physician writes a prescription for Suboxone for pain management, the prescription may be called in to the pharmacy. Suboxone prescriptions for addiction management may not be called in or faxed to the pharmacy unless the prescribing physician has obtained a signed HIPAA release form from the patient. Any further redisclosure of patient identifying information by the pharmacist is prohibited. Confirmation of a signed HIPAA release form is not required when a patient delivers the prescription to the pharmacist, without direct communication from the physician to the pharmacist.
42 CFR part 2.
Additional information from the DEA Drug and Chemical Evaluation Section can be viewed HERE.
2. What other information should I relay to patients?
It is important that you make sure patients understand the instructions from the physician, and that you answer any questions they may have. When counseling patients, be sure to discuss any relevant precautions as listed in the prescribing information, including but not limited to the following:
- Patients should be cautioned that a serious overdose may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as Suboxone or Subutex.
- Patients should be cautioned that Suboxone or Subutex may impair the mental or physical abilities required for the performance of potentially dangerous tasks, such as driving a car or operating machinery. Patients should be cautioned not to drive or operate complex machinery until they know how Suboxone or Subutex affects their ability to function in these circumstances
- Patients should consult their physician if other prescription medications are currently being used or are prescribed for future use.
3. What is the role of the pharmacist in ensuring safe use of Suboxone and Subutex?
Each time a pharmacist fills a prescription for Suboxone or Subutex, he or she must:
- Verify that the prescriptions received are from physicians who are in compliance with the provisions of the Drug Addiction Treatment Act (DATA).
- Remind patients who are picking up induction doses to return as directed to the doctor’s office so that they can be supervised while taking the medication.
- Be vigilant in detecting fraudulent prescriptions or simultaneous prescriptions for the same patient from multiple suppliers.
4. Who is qualified to prescribe Suboxone and Subutex?
The DATA limits office-based use of Suboxone and Subutex to physicians who meet special training criteria and can provide appropriate services. To be qualified, physicians must meet one or more of the following training requirements:
- Hold a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties
- Hold a subspecialty board certification in Addiction Medicine from the American Osteopathic Association
- Hold an addiction certification from the American Society of Addiction Medicine.
- Have completed no less than 8 hours of authorized training on the treatment or management of opioid-dependent patients. This training may include classroom situations, seminars at professional society meetings, electronic communications, or other media. The American Society of Addiction Medicine, The American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, and the American Psychiatric Association are all authorized to provide this training.
- AND meet both of the following criteria: Have the capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy and agree to treat no more than 30 patients at any one time in their individual or group practice.
5. How can I be sure a physician is qualified to prescribe Suboxone and Subutex?
Physicians who meet the qualification criteria listed above must also notify the Secretary of Health and Human Services of their intent to prescribe Suboxone and Subutex before doing so. Once all relevant criteria are verified, DEA will issue the physician a unique identification number indicating that he or she is a qualifying physician under the DATA. The Center for Substance Abuse Treatment will send a letter informing the physician of the new DEA identification number. The physician will subsequently receive a revised DEA registration certificate.
21 CFR §1301.28(d)(3)
6. What if I get a prescription from a doctor who does not have a special DEA identification number?
A special DEA number is not required for physicians prescribing Suboxone/Subutex for the treatment of pain. If this is the case, the prescription must indicate “for pain”. Call that physician for clarification that the physician has made the appropriate notification to DHHS. DEA is developing regulations that will require this number along with the physician’s existing DEA registration number to be included on all prescriptions issued for the treatment of opioid dependence; therefore, physicians are being strongly urged to include this number on prescriptions. Most physicians will make arrangements to obtain the identification number before prescribing Suboxone or Subutex, but in rare cases a physician may need to write a prescription before the number has been issued. This is allowed under the DATA provided the physician has notified the Department of Health and Human Services of higher intention to begin treating a patient right away; the notification form includes a check box for this situation.
21 CFR §1301.28
7. Are there any special storage, record-keeping, or other requirements associated with Suboxone and Subutex?
As Schedule III controlled substances, Suboxone and Subutex are subject to certain federal regulations covering areas such as record-keeping, inventory, proper dispensing, and disposal.
42 CFR Part 2
1. If I am a retail/ independent pharmacy and conduct non- sterile compounding are there additional rules and regulations I must abide by?
Yes, USP 795
Ala. Admin. Code 680-X-2-.43
2. Can a pharmacist compound a preparation using all over-the-counter drugs and sell the compounded preparation without a prescription?
A pharmacy may prepare a compounded drug product to be sold over the counter without a prescription order. The product shall not contain an ingredient that exceeds recommended strengths and doses for over-the-counter drugs. The finished product shall not be one for which a prescription is required. It shall be properly labeled with the product’s name, directions for use, list of active ingredients, and any necessary warnings. A compounded product shall be sold directly to the consumer after professional interaction or consultation between the pharmacist and the consumer. The product may be prepared in advance in reasonable amounts in anticipation of estimated needs. The product shall be stored within the prescription department. The product may not be sold in bulk to other pharmacies or vendors for resale.
Code of Ala. §34-23-159
OPERATING A PHARMACY
1.What is the technician to pharmacist ratio for Alabama?
The maximum technician to pharmacist ratio is 4:1, of which two must be certified by a board-approved pharmacy technician certification program.
Ala. Admin. Code 680-X-2-.14
2.What is the minimum number of hours a pharmacy must be open?
The pharmacy must be open for a minimum of twenty (20) hours per week. A pharmacy may apply to the Board for a waiver or exception under special circumstances. A representative from the pharmacy may be required to appear before the Board in order for this waiver or exception to be considered. A sign in block letters not less than one inch in height shall be displayed either at the main entrance of the establishment or at or near the place where prescriptions are dispensed in a prominent place that is in clear and unobstructed view. Such sign shall state the hours the prescription department is open each day.
Ala. Admin. Code 680-X-2-.31
3.What does the law state regarding keys to the pharmacy in Alabama?
Any pharmacy doing business within the State of Alabama must be physically enclosed, secured and locked when not open for business, except in the temporary absence of the pharmacist on duty as provided for in §34-23-70(a), Title 34, Chapter 23, Code of Alabama 1975. At all times, registered pharmacists designated by the licensee must have all keys or other controlled access device or method in their possession. The owner of the pharmacy may designate one (1) unregistered person to have a key or other controlled access device or method to the pharmacy and still be considered to be in their possession. The Supervising Pharmacist must agree to this arrangement. The enclosed and secured area must encompass all drugs, products, and devices, the character of which require dispensing or sale by a registered pharmacist, and include store rooms used for receiving or storing these items. The permit holder (owner) must execute a signed agreement with the individual in possession of a key or other controlled access device or method to the pharmacy and must submit a copy to the Board of Pharmacy for approval prior to issuing a key or other controlled access device or method to any person that does not hold an active pharmacist license in the state of Alabama. Forms for this purpose may be obtained from the Board of Pharmacy. Further, if the municipality or other government authority in the jurisdiction where a pharmacy is located requires compliance with a Fire Code that mandates making a key or other controlled access device or method to the premises available to First Responders, the permit holder (owner) must execute a signed agreement with the highest ranking official of the agency that wants access to the key or other controlled access device or method and submit a copy to the Board of Pharmacy for approval prior to providing access to a key or other controlled access device or method; the Knox Box or other system for accessing the key or other controlled access device or method must have a working tamper protection system that is connected to an alarm system that will notify the permit holder (owner) or the supervising pharmacist if an attempt is made to remove the key or other controlled access device or method by unauthorized persons. Where the pharmacist does not have access to the prescription department by other entrances after normal operating hours of the entire store, the owner shall have an action plan that allows the pharmacist to gain access in case of an emergency.
Ala. Admin. Code 680-X-2-.11
4. If my pharmacy is changing its hours of operation, how soon do I have to notify the public before implementing the change?
There is no law that requires a pharmacy to notify the public within a certain time-period before implementing its change of operating hours. A pharmacy is required to be open a minimum of twenty (20) hours per week and the hours of operation must be displayed at the pharmacy.
Ala. Admin. Code 680-X-2-.31
5.What does the Alabama law state regarding offering to counsel patients at the pharmacy?
In the best interest of the public health, the patient must be offered counseling for all new prescriptions and, where appropriate, for refill prescriptions. The offer to counsel shall be made by the pharmacist or the pharmacist’s designee in a face to face oral communication with the patient, or the patient’s representative, unless in the professional judgment of the pharmacist, it is deemed inappropriate or unnecessary. If it is deemed inappropriate or unnecessary by the pharmacist, it would be permissible for the offer to counsel to be made in a written communication, by telephone, or in a manner determined by the pharmacist to be appropriate. Said counseling must be performed by the pharmacist or properly supervised pharmacist intern. A printed statement shall be included with every prescription listing the pharmacy’s telephone number, for the patient to call with questions about their medication.
Ala. Admin. Code 680-X-2-.21
6. What does the Alabama law state regarding operating a pharmacy during pharmacist breaks?
This rule is to allow pharmacists to have breaks and meal periods without unreasonably impairing the ability of a pharmacy to remain open. In any pharmacy that is staffed by a single pharmacist, the pharmacist may leave the pharmacy area or department, temporarily, for breaks and meal periods without closing the pharmacy and removing interns/externs and technicians from the pharmacy, if the pharmacist reasonably believes that the security of the controlled substances will be maintained in his or her absence. If, in the professional judgment of the pharmacist, the pharmacist determines that the pharmacy should be closed during his or her absence, then the pharmacist shall close the pharmacy area or department and remove all interns/externs and technicians from the pharmacy during his or her absence. During the pharmacist’s temporary absence, no prescription medication may be provided to a patient or to a patient’s agent unless the prescription medication is a new or refill medication that the pharmacist has checked, released for furnishing to the patient and was determined not to require the consultation of a pharmacist. During such times that the pharmacist is temporarily absent from the pharmacy area or department, the interns/externs and technicians may continue to perform the nondiscretionary duties authorized to them by any applicable law or rule. However, any duty performed by an intern/extern or technician shall be reviewed by a pharmacist upon his or her return to the pharmacy. The temporary absence authorized by this rule shall be limited to thirty (30) minutes. The pharmacist shall remain within the facility during the break period and be available to handle all emergency situations. The pharmacy shall have written policies and procedures regarding the operations of the pharmacy area or department during the temporary absence of the pharmacist for breaks and meal periods. The policies and procedures shall include the authorized duties of interns/externs and technicians, the pharmacist’s responsibility for maintaining the security of the pharmacy. The policies and procedures shall be open to inspection by the Board or its designee at all times during business hours.
Ala. Admin. Code 680-X-2-.28
7. What steps should a pharmacist take in the event of a pharmacy burglary, robbery, or theft?
- Notify the appropriate local law enforcement agency
- File a form 106 with the DEA if controlled substances are involved located on the DEA website.
- Notify the Alabama State Board of Pharmacy
- Send a copy of DEA 106 form and a copy of the police report to ALBOP via email to email@example.com.
- If a theft is committed by an ALBOP licensed pharmacy staff member, report the name and permit or registration number of the member to the state drug inspector assigned to your area.
- If a theft of non-controlled substances occurs, notify your area ALBOP state drug inspector.
Over the Counter Medications
1. May syringes be sold in Alabama without a prescription?
Yes, syringes may be sold in Alabama without a prescription. There are a few states which still require prescriptions as part of paraphernalia laws, and some states have age restrictions on purchasing syringes. A pharmacist always has the right to deny a sale which the pharmacist believes is not appropriate.
2. What are the Alabama restrictions on the sale of ephedrine or pseudoephedrine containing products?
These products must be sold by a pharmacy licensed by ALBOP from behind the counter and a person may purchase no more than 3.6 grams per calendar day and no more than 7.5 grams per 30 days (AL law). Purchaser must be at least 18 years of age and provide a valid, unsuspended driver’s license or non-driver ID card issued by one of the 50 states, a U.S. Uniformed Services Privilege and ID card or a US or foreign passport.
Code of Ala. §20-2-190
3. Does Alabama law require a “wet signature” or hand signed signature on prescriptions given to the patient for non-controlled drugs?
The Alabama Pharmacy Practice Act references “Every written prescription issued in this State by a licensed practitioner” ….and “the practitioner shall communicate the instructions to the pharmacist by SIGNING on the appropriate line.” It does not limit the prescriptions to Controlled Substances only. Any time a prescription is printed out from a fax machine and provided to a patient to take to a pharmacy, or defaults to a pharmacy’s fax machine for filling, it is not an “Electronic Prescription.” That prescription becomes an original, hard copy prescription and it must have an original “wet signature” on it. That means that if it is faxed to a pharmacy, or if it is understood that it will default to the pharmacy’s fax machine, you must stop the transmission of the prescription, sign the prescription and then you can send it on to the pharmacy.
Code of Ala. §34-23-8(4)
1. Can a prescription be filled/refilled which was written by a prescriber who is now deceased or retired?
The Code of Federal Regulations states the (DEA) registration of any person terminates when such person:
- a. dies,
- b. ceases legal existence,
- c. discontinues business,
- d. discontinues professional practice or,
- e. surrenders a registration.
The Alabama Board of Pharmacy has taken the position that where a prescription has been issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, and the practitioner is deceased, a pharmacy may fill such a valid prescription (after the practitioner’s death) for a maximum 30-day supply. The patient should be instructed that no additional refills may be given, and a new prescription will be required. The board is in agreement that the CFR makes clear that a DEA registration becomes void at the time of death or retirement; however, the board also feels that prescriptions written prior to death or retirement may be filled because the DEA registration was valid at the time written. The board determined that a 30-day supply would be in the best interest of the patient by ensuring continuity of care. In any event, the board expects pharmacists to use their professional judgment.
21 CFR §1301.52
Prescribers Treating Family Members/Self
1. Under what circumstances can physicians treat themselves or members of their immediate families?
Physicians generally should not treat themselves or members of their immediate families except in emergency settings or isolated settings where there is no other qualified physician available and only until another physician becomes available. Prescribing or dispensing a controlled substance to oneself or to one’s spouse, child, or parent is not allowed unless such prescribing or dispensing is necessitated by emergency or other exceptional circumstances.
Ala. Admin. Code 545-X-4-.06
2. What is the process for pharmacists if they suspect a physician is writing prescriptions for family members or themselves?
Pharmacists should contact the Board of Medical Examiners if they experience physicians writing controlled substances to family members, or especially to themselves. It can avert future problems for the physician who is simply acting out of a lack of understanding or be the catalyst for help for an impairment issue.
3. Are physicians allowed to prescribe non-controlled medications to treat themselves or immediate family members?
The Alabama Board of Medical Examiners (ALBME) makes clear that physicians should only prescribe controlled substances for themselves or immediate family members under certain circumstances; however, there is no such clarity regarding non-controlled medications. The American Medical Association (AMA) Code of Medical Ethics,Opinion 1.2.1, seems to be the standard adopted by ALBME, as recently as 2017. This opinion expresses concerns which speak to issues that are not specific to controlled substances, such as: professional objectivity being compromised, personal feelings influencing professional judgment, failing to probe sensitive areas when taking a medical history, patients feeling uncomfortable in disclosing sensitive information, physicians being inclined to treat conditions beyond their expertise/training, development of tensions in a professional relationship with a family member, concerns of patient autonomy and informed consent and a reluctance to state a preference for another physician. ALBME has not issued any current guidance on this topic, therefore, pharmacists are advised to use professional judgement when presented with such prescriptions for non-controlled prescription medications.
PRESCRIPTIONS: CONTROLLED SUBSTANCES
1. What are the requirements for schedule II controlled substances?
Schedule II controlled substances require a written prescription which must be manually signed by the practitioner or an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances.
21 CFR §1306.11(a)
2. Is there a time limit within which a schedule II prescription must be filled after being signed by the practitioner?
No. However, the pharmacist should determine that the prescription is still needed by the patient.
21 CFR §1306.12
3. Is there a limit to the quantity of controlled substances dispensed to a 30-day supply?
No. While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no expressed federal limits with respect to the quantities of drugs dispensed via a prescription. However, the amount dispensed must be consistent with the requirement that a prescription for a controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
4. Is an oral order for a schedule II controlled substance permitted?
No. Only in an emergency situation for a resident of a long-term care facility, a patient receiving hospice services, or a patient receiving home healthcare services is an oral order for a schedule II controlled substance permitted. The physician must provide a hard copy of the prescription within 7 days. If the prescriber does not provide said hard copy, the pharmacist is responsible for contacting the DEA.
21 CFR §1306.11(d)
5. What items may be changed on a Schedule II prescription?
Since there are no direct rulings in Alabama Pharmacy Statutes, Alabama pharmacists may refer to the DEA Diversion Website, which states a pharmacist may change or add the dosage form, drug strength, drug quantity, direction for use, or issue date only after consultation with and agreement of the prescribing practitioner. Dates for prescriptions which are dated for later fill may not be changed even after consultation with and permission of the prescribing physician.
ALBOP Policy 20100825
6. What information is required on a prescription for a controlled substance?
A prescription for a controlled substance must include the following information:
- Date of issue
- Patient’s name and address
- Practitioner’s name, address, and DEA registration number
- Drug name
- Drug strength
- Dosage form
- Quantity prescribed
- Directions for use
- Number of refills (if any) authorized
- Manual signature of prescriber
A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.
21 CFR §1306.05
7. May a prescriber use an electronic signature in preparing a prescription?
In Alabama, a prescription which is printed or prepared in the prescriber’s office for a controlled drug may NOT have a signature from the printer, or an electronic signature. All prepared or hard copy prescriptions for controlled substances must have a “wet” signature. This means the prescription must be signed manually.
21 CFR §1306.05(d)
Code of Ala. §34-23-8(4)
8. Can controlled substance prescriptions be refilled?
Prescriptions for schedule II controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months. Prescriptions for schedule V controlled substances may be refilled as authorized by the practitioner.
21 CFR §1306.12(a)
21 CFR §1306.22(a)
9. Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
Yes. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue.
21 CFR §1306.23
10. Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?
A prescription written for a schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile.
A pharmacist may dispense directly a controlled substance listed in schedules III, IV, or V pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
21 CFR §1306.11
11. Is it appropriate to provide a DEA registration number on prescriptions written for medications other than controlled substances?
DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend beyond May 23, 2008.
12. What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that “the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally.”
The instructions contained in the Rule’s preamble are in opposition to DEA’s previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations*** or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.
***ALABAMA PERMITS THE SAME CHANGES AS MAY BE MADE TO A SCHEDULE III-V.
ALBOP Policy 20100825
13. What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
The pharmacist may add or change the patient’s address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber’s signature.
14. Can a practitioner prescribe methadone for the treatment of pain?
Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV, or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by a registered practitioner acting in the usual course of professional practice.
Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment Program (NTP).
15. Can an individual return his/her controlled substance prescription medication to a pharmacy?
The Code of Federal Regulations does have a provision for an individual to return his/her unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred.
An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.
16. Under what conditions can a controlled substance prescription, CII-CV be issued electronically (E-prescribing)?
Requirements for issuing and processing controlled substance prescriptions:
Prescribers must be properly registered and have authority to dispense controlled substances; use an electronic prescription application which meets all applicable requirements; and, the prescriptions issued must conform with the requirements of a valid electronic prescription.
A pharmacy can process electronic prescriptions for controlled substances when using a pharmacy application which meets all applicable requirements; and, where the prescription conforms with the requirements of a valid electronic prescription.
Both the prescriber and pharmacy are responsible for ensuring the validity of a controlled substance prescription.
21 CFR §1311.100
17. What changes may be made to a CII prescription?
CII prescription (Federal): “When information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.”
18. What changes may be made to a CIII- CV prescription?
CIII, IV, V (State): A pharmacist may add/ change dosage form, strength, quantity, directions, issue date, or patient address only after speaking with prescriber and documenting on the prescription. If the prescription is missing the prescriber’s signature, pharmacist must then forfeit the written prescription and take a new one verbally and reduce to writing.
19. Can you do a partial fill on a CII prescription?
The partial filling of a Schedule II prescription is permissible as follows:
A) The Comprehensive Addiction and Recovery Act (C.A.R.A.) amended the federal controlled substances act to allow pharmacists to partially fill a prescription for a Schedule II controlled substance if:
- such partial fills are not prohibited by state law,
- the prescription is written and filled in compliance with federal and state law.
- a partial fill is requested by the patient or the prescribing practitioner; and
- the total quantity dispensed in all partial fillings does not exceed the quantity prescribed.
Remaining portions of partially filled prescriptions must be filled within 30 days of the original written prescription date.
21 U.S.C. §829(f)(1)
B) Where a pharmacist is unable to supply the full quantity of the prescription and the pharmacist makes a notation of the quantity supplied, then the remaining portion may be filled within 72 hours of the first partial filling. If not filled within 72 hours, the remaining balance is forfeited, and a new prescription is required. This is generally related to an inventory shortage in which a pharmacy is unable to acquire a Schedule II drug to fill the remaining quantity owed to a patient. Where a pharmacist is aware, at the time of the partial dispensing, that the pharmacy may not be able to obtain sufficient inventory within 72 hours, the pharmacist should notify the patient prior to the partial dispensing.
C) Schedule II prescriptions written for a patient in a long-term care facility (LTCF) and patients with a diagnosis of a terminal illness may be filled in partial quantities.
21 CFR §1306.13
**Keep in mind that a pharmacy computer system must be capable of processing a Schedule II partial fill under the original prescription number without assigning a new number to each fill.
20. Can a prescription for Suboxone be called in and what number must be obtained from the doctor for the prescription to be valid?
Yes, Suboxone is a CIII prescription and may be called in but does have necessary requirements in order to be valid. If the prescription is for opioid addiction, the prescriber must be a qualified physician and provide a DEA number with an “X’ in front of it to confirm prescriber has certified authorization. If it is for the treatment of pain the physician’s DEA number is required.
21. Should an Alabama pharmacy honor a CII prescription from an out-of-state nurse practitioner?
Yes, because registered nurse practitioners have prescriptive authority to prescribe a CII in the state of Alabama.
22. May a prescriber write multiple CII prescriptions for the same patient and same medication on same day office visit?
Yes, the patient may receive multiple prescriptions; but the current date must be written on all of the prescriptions, it cannot exceed a 90-day supply, and it may not be postdated. The prescriber must include instructions in the body of each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.
21 CFR §1306.12
23. Can a pharmacist fill an emergency prescription refill for a CII?
No, a CII cannot be refilled without a new valid written prescription.
EXCEPTION:In an emergency situation, a pharmacist may dispense a CII for a resident of a long-term care facility, a patient receiving hospice services, or a patient receiving home health care services pursuant to an emergency oral prescription transmitted by a prescriber. The quantity dispensed is limited to the amount necessary to adequately treat the patient during the emergency period and not to exceed 72 hours. The prescriber must then provide the pharmacy with a written prescription within 7 days of the emergency orally transmitted prescription. The written prescription must have “Authorization for Emergency Dispensing” and the date of the oral order written on it and it needs to be attached with the written verbal order previously taken by the pharmacist.
24. Can you use a partially/ fully pre-populated refill request form for a controlled substance?
No, because the practitioner must determine whether or not there is a legitimate medical purpose for the prescription.
25. Is there an expiration for schedule III substances?
Prescriptions for Schedule III substances expire 6 months after the date written. There may be 5 refills within the 6-month period. Refill authorization can be transferred from one pharmacy to another once within the 6-month period. Pharmacies operating within the same computer system may transfer refills multiple times. A practitioner may issue a new prescription for the Schedule III substance within a 6-month period if necessary.
21 CFR §1306.23
26. Are refills permitted for controlled substances?
The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. However, an authorized prescriber may prepare multiple prescriptions on the same day with instructions to fill on different dates.
21 CFR §1306.12
Prescriptions for Schedule III and IV controlled substances may be refilled up to 5 times in 6 months. Prescriptions for Schedule V controlled substances may be refilled as authorized by the prescriber. A prescription for Schedule III, IV or V controlled substances may be either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy, an electronic prescription, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
21 CFR §1306.21
21 CFR §1306.22
27. What is the proper way to handle emergency situations?
Emergency is defined by the Secretary of Health and Human Services as “situations in which the prescribing practitioner determines that: (1) immediate administration of a controlled substance is necessary, for proper treatment of the intended ultimate user; (2) that no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and (3) it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing”.
21 CFR §290.10
In emergency situations, a prescription for a Schedule II controlled substance may be phoned-in to the pharmacy for a resident of a long-term care facility, a patient receiving hospice services, or a patient receiving home healthcare services. The prescriber must follow up with a written prescription sent to the pharmacy within 7 days. (States may require that the prescription be sent to the pharmacist in a shorter time frame.) Prescriptions for Schedule III through V controlled substances may by written or transmitted orally or by fax.
Code of Ala. §20-2-58(g)
Here are some additional requirements to heed when orally transmitting prescriptions in emergency situations: “In an emergency, the prescriber may give an oral prescription for a Schedule II drug if the pharmacist makes a reasonable effort to identify the prescriber and the amount is limited to what is necessary to treat the patient during the emergency. The prescriber must cause to be delivered an original prescription to the dispensing pharmacist within 7 days. The prescriber must write ‘Authorization for Emergency Dispensing’ on the prescription. The prescriber must document how the situation met the criteria for emergency treatment”.
21 CFR §1306.11
28. Is it permissible to fax prescriptions for controlled substances?
Schedule II prescriptions can be faxed to a pharmacy by the practitioner or the practitioner’s agent:
1. as an alert to the pharmacist that the patient is in route with an original prescription and, the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance;
2. when written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion. The practitioner or the practitioner’s agent may transmit the prescription to the pharmacy by facsimile. The facsimile serves as the original written prescription;
3. when written for a resident of a Long-Term Care Facility; and
4. when written for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state.
21 CFR §1306.11
Prescriptions for Schedule III, IV or V controlled substances may be either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy, an electronic prescription, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
21 CFR §1306.21
29. Does Alabama have a Prescription Drug Monitoring Program (PDMP) and who has access?
Yes, licensed prescribers, dispensers, and law enforcement all have potential access to the PDMP. In order to gain access, you must be a licensed physician, physician assistant, or pharmacist in the state of Alabama and fill out the appropriate application. The program is managed by the Alabama Department of Public Health.
Code of Ala. §20-2-214
Prescriptions: C-II with Multiple Prescriptions
1. What does the rule state concerning the issuance of multiple prescriptions for schedule II controlled substances?
A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90-day supply of that controlled substance.
21 CFR §1306.12(b)(1)
2. What are the requirements for the issuance of multiple prescriptions for schedule II controlled substances?
Each prescription issued is for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice. The individual practitioner must provide written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription. The issuance of multiple prescriptions is permissible under applicable state laws. The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and implementing regulations, as well as any additional requirements under state law.
21 CFR §1306.12
3. Does this rule require or mandate a practitioner to issue multiple prescriptions for schedule II controlled substances?
No. This rule does not require individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days.
21 CFR §1306.12(b)(2)
4. Is there a limit on the number of schedule II dosage units a practitioner can prescribe to a patient?
There is no federal limit as to the amount of controlled substances a practitioner can legitimately prescribe. However, if a registered practitioner issues multiple schedule II prescriptions, he/she is limited to the combined effect of allowing a patient to receive, over time, up to a 90-day supply of a particular schedule II controlled substance.
5. Is there a limit on the number of separate prescriptions per schedule II controlled substance that may be issued for the 90-day supply?
This rule does not stipulate how many separate prescriptions per schedule II controlled substance may be issued for the 90-day supply. It is up to the practitioner to determine how many separate prescriptions to be filled sequentially are needed to provide adequate medical care. For example, a practitioner may issue three 30-day schedule II prescriptions to cover a 90-day supply or he/she may issue nine prescriptions for the same schedule II controlled substance, each for a ten-day supply, having the combined effect of a 90-day supply.
21 CFR §1306.12
6. How is the issuance of multiple schedule II prescriptions different than issuing a refill of a schedule II prescription?
The issuance of refills for a schedule II controlled substance is prohibited by law. The use of multiple prescriptions for the dispensing of schedule II controlled substances, under the conditions set forth in the Final Rule, ensures that the prescriptions are treated as separate dispensing documents, not refills of an original prescription. Each separate prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Each separate prescription must contain written instructions indicating the earliest date on which a pharmacy may fill each prescription.
21 CFR §1306.12(a)
7. What is expected of the pharmacist when filling a prescription issued pursuant to this regulation?
Where a prescription contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. In addition, when filling any prescription for a controlled substance, a pharmacist who fills multiple prescriptions issued in accordance with this regulation has a corresponding responsibility to ensure that each sequential prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
21 CFR 1306.14(e)
8. Is post-dating of multiple prescriptions allowed?
No. Federal regulations have always required that all prescriptions for controlled substances “be dated as of, and signed on, the day when issued.”
21 CFR 1306.05(a)
1. May a pharmacist process Schedule II through V prescriptions using e-prescribing?
Yes, assuming the proper requirements for proper e-prescribing have been met.
21 CFR 1311.100
2.What are the record requirements for e-prescribed controlled substances?
All records must be backed up daily and stored for a minimum of 2 years.
21 CFR 1311.305
3.What are the options for prescribers to be credentialed?
The prescriber must be credentialed. The prescriber must use two of these three credentials:
- a password or response to a challenge question
- a biometric, such as a fingerprint or iris scan
- a hard token, such as a cryptographic module
The act of applying the two credentials ensures the legal electronic signature on the prescription. The software should not permit the transmission of the controlled e-prescription unless the prescription is properly signed by a credentialed prescriber using the two-factor system.
21 CFR 1311.115
4. What are the software requirements for e-prescribing controlled substances?
The software used by the prescriber and the software used by the pharmacy must be audited by a third party, and that third party must be approved by the DEA. In the situation where the prescription has been digitally signed by the prescriber using his or her private cryptographic key, the pharmacy software must be able to apply the prescriber’s public key to confirm that the prescription was, in fact, signed. The software must check to verify that the prescriber’s digital certificate is still valid and has not been revoked. Otherwise, the software must be able to read and/or display the transmitted flag indicating that the prescription was signed. The soft must retain the full DEA number of the prescriber. On receipt of a controlled-substance e-prescription, the software must digitally sign the prescription. The digitally signed prescription must then be archived by the software. The pharmacy software must have logical access controls that restrict access by name or role. The software must store all applicable dispensing information, such as the number of units dispensed. it must also have an internal audit trail, and must perform automated internal audits and provide reports of incidents to the pharmacist.
21 CFR 1311.120
Prescriptions: Noncontrolled Substances
1. What must be included as the content of the prescription?
Alabama law states that every written prescription issued in this state by a licensed practitioner shall contain two signature lines. Additionally, Alabama Administrative Code requires, for recordkeeping purposes, that a pharmacy’s computerized system must be able to store and retrieve “original prescription orders” to include: original prescription number, prescriber’s name, full name and address of the patient, date the original prescription was issued and the name, strength, dosage form and quantity dispensed.
Federal regulations state the prescription should include the name and address of the patient; name, address, and DEA number of the prescriber; name, strength, dosage form, quantity of the drug prescribed; directions for use, number of refills, and signature of the prescriber. A prescription may only include one page and may not be multiple pages with a signature at the end. A prescription should be for one patient.
21 CFR §1306.05
Code of Ala. §34-23-8(4)
Ala. Admin. Code 680-X-2-.15
Ala. Admin. Code 680-X-2-.45
Refusal to Fill
1. What grounds are listed in the Board rule on refusing to fill or refill a prescription?
Pharmacists may refuse to fill or refill prescriptions if they believe it would be harmful to the patient, if there’s a question as to its validity, or they believe it is not in the patient’s best interest.
1. What is the “immediate use” exemption?
Three or fewer sterile products may be used to compound in worse than ISO Class 5 air when there is no direct contact or contamination, and administration begins within 1 hour of the start of compounding. Unless immediately and completely administered by the person who prepared it, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1-hour BUD and time.
2. What is an FDA Outsourcing facility?
Federal law defines an outsourcing facility as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of Section 503B (of the DQSA).
An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directors for us, but not the exemption from current good manufacturing practice (cGMP) requirements.
- Must comply with cGMP requirements
- Will be inspected by FDA according to a risk-based schedule
- Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound
3. If a commercially available FDA product is available, what would the Board of Pharmacy’s position be on compounding the same material using USP 797 conditions instead of buying the commercially available product?
Please be advised that you may not compound a prescription for a medication that is readily and commercially available. The Food and Drug Administration Modernization Act of 1997 (FDAMA) prohibits pharmacists from compounding “essentially copies” of commercially available drug products.
21 U.S.C. §353a
4. May a pharmacy provide samples of compounded medications to physicians and provide compounded medications of non-commercial products for use by physician in office?
Compounding is only allowed pursuant to a patient-specific prescription. If you would like to perform office use compounding, you should be registered with the FDA as an outsourcing facility.
5. How often must one successfully complete written and media- fill testing when preparing low or medium-risk compounded sterile products (CSPs)?
6. How often must one successfully complete written and media-fill testing when preparing high- risk compounded sterile products (CSPs)?
7. Which type CSP risk level can be prepared for immediate use?
Only low-risk CSPs may be compounded for immediate use.
8. How soon must an immediate use, low-risk CSP be used?
The immediate use, low-risk compound must be administered within one hour or less from the start of preparation. Otherwise, the preparation must be discarded.
9. Can a single- dose or single- use vial be used for more than one patient?
No, vials that are labeled single- dose/use, are only to be used once for an individual patient.
10. How many times can you access a single- dose or single-use vial for a single patient?
You should only enter the vial once to prevent contamination.
11. What is the maximum beyond- use date for a single use container (i.e. bags, bottles, vials, etc.)?
The maximum beyond-use date is six hours after entry into the vial, if the vial is entered in at least an ISO Class 5 environment. If it’s entered in less than an ISO Class 5 environment (i.e. 6), the maximum beyond-use date is one hour.
12. Can I prepare sterile and non- sterile compounds in the same?
No, there must be two distinct, separate areas, one for sterile compounding preparation and another for non-sterile compounding preparation. (See USP 797 Environmental and Quality Control)
13. What are some of the drugs that have been identified as “hazardous drugs”?
Testosterone, Estrogen, Progesterone, Chemotherapy
(More info and a more through list of medications can be found at: http://www.cdc.gov/niosh/topics/hazdrug/).
** Employees handling these medications must sign a consent form stating they have been trained on proper handling and they understand the potential risks associated**
14. What type of sink is required if in the ante-room?
There may be a hands-free sink located in the ante-room with either a sensor, foot pedal, or something of that nature. (Information located: USP 797 “Additional requirements”).
15. What are the requirements for the ceilings where sterile products are prepared and/or compounded?
“Junctures of ceilings to walls shall be coved or caulked to avoid cracks and crevices where dirt can accumulate. If ceilings consist of inlaid panels, the panels shall be impregnated with a polymer to render them impervious and hydrophobic, and they shall be caulked around each perimeter to seal them to the support frame.” (Information located: USP 797 “Facility Design and Environmental Controls”)
16. What type of environment must I weigh or mix non- sterile products in?
An ISO 8 environment or better (i.e. 7)
17. How many air exchanges are required in both the buffer and ante rooms per hour?
A minimum of 30 air- exchanges per hour
18. Can a pass-through be used between the buffer room and the general pharmacy?
General Chapter <797> does not specifically address pass-through from a cleanroom to an unclassified room. Ideally, a pass-through should have interlocks to prevent both doors from being open at the same time, therefore preventing transfer of contamination during material transfer. The suitability of using the pass-through should be supported by environmental monitoring. The buffer room should be evaluated for viable and nonviable particles during static operations. If the buffer room has a pass-through, it should be used during the time of evaluation to determine the impact of ISO 7 air.
19. What will an inspector be looking at during an inspection of a sterile compounding facility?
The inspector will be reviewing policies and procedures; training logs, including Glover finger testing, aseptic technique, and cleaning; cleaning logs; temperature logs; observed compounding procedures; compounding logs; and room(s) and hood(s) certifications.
20. Where must a pressure meter be placed when conducting sterile compounding?
A pressure meter is needed where the ante room connects to general pharmacy and if there is a wall between the buffer and ante room, a pressure sensor is needed there too. If there is no wall between the ante and buffer rooms then there needs to be a velocity meter at the division line between buffer and ante-room.
Weight Loss Medications
1. May a physician prescribe a Schedule II controlled substance for patients for the purpose of weight reduction?
2. May a physician or agent of a physician call in orders for controlled substances for patients for the purpose of weight reduction?
No, such prescriptions may not be called in to a pharmacy by the physician or agent of the physician. Such prescriptions may be written or e-prescribed.
Ala. Admin. Code 540-X-17-.03(2)
3. May anyone other than a licensed MD or DO prescribe controlled substances for weight reduction?
Only a doctor of medicine or doctor of osteopathy licensed by the Medical Licensure Commission of Alabama may order, prescribe, dispense, supply, administer or otherwise distribute a controlled substance in Schedule III, IV or V to a person for the purpose of weight control, weight loss, weight reduction or treatment of obesity. Certified Registered Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants are not authorized to prescribe or dispense any controlled substance for the purpose of weight control.
Ala. Admin. Code 540-X-17-.03
4. What is the maximum days’ supply a physician may prescribe for a weight loss medication?
Physicians may only prescribe a maximum of 35 days’ supply of medication. At the end of that prescription, the patient must be seen by the physician, a physician assistant, or a certified registered nurse and should be evaluated. If medically established goals have been met, the patient may have another prescription for a 35-day supply.
Ala. Admin. Code 540-X-17-.05
5. Under what circumstances may a patient be eligible for a prescription for a weight loss medication?
The patient should have any of the following before being prescribed a weight loss medication:
- Body Mass Index (BMI) of 30 or above
- Body Mass Index (BMI) of greater than 25 with at least one comorbidity factor
- Male patients: A measurable body fat content greater than or equal to 25% of total body weight
- Female patients: A measurable body fat content greater than or equal to 30% of total body weight
- Male patients: An abdominal girth of at least 40 inches.
- Female patients: An abdominal girth of at least 35 inches
6. Under what circumstances may a prescription for weight loss medication be refilled?
Only non-controlled drugs prescribed for the treatment of obesity may be refilled.
Ala. Admin. Code 540-X-17-.05